Can J Diabetes 45 (2021) 228e235

Contents lists available at ScienceDirect

Canadian Journal of Diabetes

journal homepage:
www.canadianjournalofdiabetes.com

Original Research

Revision of Alberta’s Provincial Insulin Pump Therapy Criteria for

Adults and Children With Type 1 Diabetes: Process, Rationale and
Framework for Evaluation
Dalal Haddadi MD a; Elizabeth Rosolowsky MD b; Danièle Pacaud MD c; Julie McKeen MD d;
Kim Young RD e; Bev Madrick RN f; Lorelei Domaschuk RN g; Peter Sargious MD h;
Sue Conroy MN i; Peter A. Senior MBBS, PhD a, *; on behalf of the
Alberta Provincial Insulin Pump Therapy Program Clinical Advisory Committee
a
Division of Endocrinology and Metabolism, University of Alberta, Edmonton, Alberta, Canada
b
Division of Pediatric Endocrinology, University of Alberta, Edmonton, Alberta, Canada
c
Division of Pediatric Endocrinology, University of Calgary, Calgary, Alberta, Canada
d
Division of Endocrinology and Metabolism, University of Calgary, Calgary, Alberta, Canada
e
Nutrition Services, Alberta Health Services, Calgary, Alberta, Canada
f
Endocrinology & Metabolism Program, Alberta Health Services, Calgary, Alberta, Canada
g
Provincial Insulin Pump Therapy Program, Alberta Health Services, Lacombe, Alberta, Canada
h
Diabetes, Obesity, Nutrition Strategic Clinical Network, Alberta Health Services, Calgary, Alberta, Canada
i
Provincial Clinical Programs, Alberta Health Services, Calgary, Alberta, Canada

Key Messages

Insulin pump therapy, is an effective, but costly therapy. Alberta has recently implemented new pump criteria, developed by a
clinical advisory committee.

Effective self-management education is an essential prerequisite for safe and effective pump therapy.

Explicit criteria defining indications and requirements to start and continue on insulin pump therapy will help focus resources and
evaluation.

a r t i c l e i n f o a b s t r a c t

Article history:
Objectives: Insulin pump therapy is a valuable, but costly approach, with public funding in Alberta for
Received 25 November 2019
eligible individuals since 2013. The Provincial Insulin Pump Therapy Program Clinical Advisory Com-
Received in revised form
7 August 2020 mittee has revised and updated the clinical criteria, integrating current literature, best practice and
Accepted 10 August 2020 feedback from clinicians. The objective was to develop criteria that would: 1) optimize safety and
effectiveness of insulin pump therapy, while 2) carefully stewarding resources available to care for people
Keywords: with type 1 diabetes.
criteria Methods: The Clinical Advisory Committee comprised health-care professionals with expertise in pump
insulin pump therapy and included adult and pediatric endocrinologists, an internist, a pediatrician, certified pump
policy trainers, diabetes educators and clinic managers. The group meets regularly by teleconference. Decisions
type 1 diabetes are made by consensus.
Results: Indications for insulin pump therapy for adults and children with insulin-deficient diabetes were
divided into 4 hierarchical levels: 1) problematic hypoglycemia, inability to achieve acceptable control or
progressive complications; 2) unpredictable activity, dawn phenomenon or children for whom use of
multiple daily injections is not appropriate; 3) individual preference and 4) clinical exception, with
priority given to indications with clear evidence of benefit. The criteria emphasize the importance of: 1)
adequate education in diabetes self-management; 2) adequate trial of flexible insulin therapy with
modern analogues and 3) evidence of active, safe diabetes self-management. Tools to facilitate effective

* Address for correspondence: Peter A. Senior MBBS, PhD, Division of Endocrinology and Metabolism, University of Alberta, 9.114 CSB, 11350 83 Avenue, Edmonton, Alberta
T6G 2S3, Canada.
E-mail address: psenior@ualberta.ca

1499-2671/Ó 2020 Canadian Diabetes Association.

The Canadian Diabetes Association is the registered owner of the name Diabetes Canada.
https://doi.org/10.1016/j.jcjd.2020.08.097
 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235 229

and efficient annual review and surveillance were developed incorporating biological, behavioural
evaluation and self-reflection to provide a framework for program evaluation. The recommendations
were implemented in January 2019.
Conclusions: The process and revised criteria may be valuable for jurisdictions considering how to
develop and implement a publicly funded insulin pump program.
Ó 2020 Canadian Diabetes Association.

Mots clés: r é s u m é
critères
pompe à insuline Objectifs : Le traitement par pompe à insuline offerte aux individus admissibles de l’Alberta depuis 2013 est
politiques une approche de financement public très utile, mais coûteuse. Le comité consultatif clinique du programme
diabète de type 1
provincial de traitement par pompe à insuline a révisé et actualisé les critères cliniques en intégrant la lit-
térature actuelle, les meilleures pratiques et les commentaires des cliniciens. L’objectif était d’élaborer des
critères qui permettraient : 1) d’optimiser l’innocuité et l’efficacité du traitement par pompe à insuline; 2) de
gérer prudemment les ressources disponibles pour soigner les personnes atteintes du diabète de type 1.
Méthodes : Le comité consultatif clinique regroupait des professionnels des soins de santé qui ont une
expertise dans le traitement par pompe et des endocrinologues en milieu adulte et pédiatrique, des
internistes, un pédiatre, des formateurs agréés en pompe, des éducateurs en diabète et des gestionnaires de
cliniques. Le groupe se rencontre régulièrement par téléconférence. Les décisions sont prises par consensus.
Résultats : Les indications de traitement par pompe à insuline chez les adultes et les enfants ayant un
diabète insulinodépendant ont été divisées en 4 niveaux hiérarchiques : 1) l’hypoglycémie problém-
atique, l’incapacité à atteindre une régulation acceptable ou les complications évolutives; 2) l’activité
imprévisible, le phénomène de l’aube ou les enfants pour qui l’utilisation de nombreuses injections
quotidiennes ne convient pas; 3) les préférences individuelles; 4) les exceptions cliniques, dont la pri-
orité est donnée lors d’indications qui démontrent clairement des avantages. Les critères démontrent
l’importance de : 1) l’éducation à la prise en charge autonome du diabète; 2) l’essai approprié de l’in-
sulinothérapie fonctionnelle à l’aide d’analogues modernes; 3) la démonstration d’une prise en charge
autonome active et sécuritaire du diabète. Des outils qui incorporent l’évaluation et l’autoréflexion sur les
comportements et les résultats biologiques pour favoriser l’efficacité et l’efficience de l’examen et la
surveillance annuels ont été élaborés dans le but d’offrir un cadre à l’évaluation du programme. Les
recommandations ont été mises en œuvre en janvier 2019.
Conclusions : Le processus et les critères révisés peuvent être très utiles aux provinces et territoires si l’on
tient compte de la façon d’élaborer et de mettre en œuvre un programme de financement public des
pompes à insuline.
Ó 2020 Canadian Diabetes Association.

Introduction
Intensive insulin therapy is recommended for the management
of type 1 diabetes (T1D) to reduce the risk of microvascular and
macrovascular complications, but it must be balanced against the
risk of hypoglycemia (1,2). Intensive insulin therapy is delivered with
multiple daily injections (MDI), or by continuous subcutaneous
insulin infusion—also referred to as insulin pump therapy (IPT).
Flexible insulin therapy, where individuals self-adjust insulin doses
depending on meal size and content, blood glucose and activity
levels, is generally recommended, irrespective of the mode of insulin
delivery (1,2). Both MDI and IPT can achieve excellent glycemic
control, but IPT is more expensive (in Alberta, health-care costs were
estimated to be 8-fold higher in adults and 20-fold higher in children
enrolling in the pump program) (3). In Canada, IPT is publicly funded
in all provinces and territories, although several provinces limit
coverage to children and young adults. Each province has deter-
mined its own policies around eligibility, access and coverage.
Alberta Health has provided coverage for insulin pumps for
adults and children with T1D since 2013 through the Provincial IPT
Program. This program covers the full costs of pumps, supplies and
up to 7 capillary blood glucose monitoring strips per day. There are
10 designated pump centres throughout the province (Figure 1A),
which provide pump education and supervise initiation and
continuation of pump therapy. Reimbursement is administered by
Alberta Blue Cross (Figure 1B).
At launch, clinical criteria were provided for authorized pump
prescribers and pump centres to identify individuals who were
eligible to enrol in and then continue in the Provincial IPT Program.
The original criteria required a diagnosis of T1D, 4 blood glucose
tests per day, regular attendance at diabetes appointments and
adequate blood glucose control (glycated hemoglobin [A1C] 9.0%,
or 9.5% for children <6 years old), but did not emphasize potential
goals or indication for why IPT may be preferred over MDI. An
evaluation of the initial program was conducted over a 2-year
period focused on cost-effectiveness, but was limited to a subset
of participants who provided research consent (3).
Subsequently, a Clinical Advisory Committee (CAC) was estab-
lished to review the IPT criteria, provide ongoing oversight of the
program and give clinical and strategic advice on the operation of
an effective Provincial IPT Program. The CAC includes a represen-
tative from Alberta Health, and interacts with key structures within
Alberta Health Services (the single provincial health authority)
(Figure 1B). One of the first activities undertaken by the CAC was
the review of the IPT clinical criteria.
The CAC identified the absence of a framework for ongoing
evaluation or quality assurance as a significant deficit and noted
substantial uncertainty and heterogeneity in the interpretation and
application of the initial clinical criteria among different prescribers
and centres. In particular, a narrow and rigid interpretation of the
need for patients to achieve and sustain an A1C of <9.0% to be
eligible and remain in the pump program had emerged as prob-
lematic. Several cases of people with severe hypoglycemia associ-
ated with unpredictable work schedules who were considered
ineligible because they ran high A1C (to avoid episodes of severe
hypoglycemia) had come to light. Also, pump centres had identified
230 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235

Figure 1. (A) Population density map of Alberta shows the locations of currently approved pump clinics serving adults or children or both. (B) Schematic organization chart
illustrates the central role of the CAC linking key structures within Alberta Health Services (DON Strategic Clinical Network and PIPTP) and the Ministry of Health and the rela-
tionships with AB Blue Cross, which administers payments and reimbursement for pumps and supplies, and locally approved pump clinics that deliver education, support and
clinical care to insulin pump users. AB, Alberta; CAC, Clinical Advisory Committee; DON, Diabetes Obesity and Nutrition; PIPTP, Provincial Insulin Pump Therapy Program.

that many individuals seeking pumps had inadequate knowledge
or skills in diabetes self-management, which, if addressed, would
not require IPT to improve clinical and patient important out-
comes—or unrealistic expectations of IPT. Furthermore, without
defining the indications for pump therapy in each case it would not
be possible to accurately determine whether IPT had been effective.
For example, if IPT were started for severe hypoglycemia, the
outcome of interest would be frequency of hypoglycemia rather
than reduction in A1C, which, on the other hand, would be a much
more important outcome if IPT were started to improve control in
the context of microvascular complications.
In the light of these observations, the CAC initiated a process to
revise and update the clinical criteria, based on consensus, by
integrating current literature, best practice and feedback from cli-
nicians working in pump centres. The overall objective was to
develop criteria that would: 1) optimize safety and effectiveness of
IPT, while 2) carefully stewarding resources available to care for
people with T1D. These criteria would form the basis for ongoing
evaluation and monitoring of the pump program.
Herein we describe the revision process, present the revised pump
clinical criteria and discuss the rationale and justification for the
recommendations. In addition, we present the tools for enrolment
and annual review designed to facilitate optimal clinical engagement,
self-management support and ongoing program evaluation.
experience and challenges faced by pump clinics. The revised
criteria were submitted to the Minister of Health for approval.
The CAC identified these guiding principles at the beginning of
their work:
1. Optimization of health outcomes (including quality of life) in
terms of both safety and effectiveness for individuals with
diabetes using IPT.
2. Ensuring responsible utilization and equitable allocation of
resources available for the care of all people with T1D.
Revised criteria to start insulin pump therapy
The major changes were: 1) a more structured approach to
applying the criteria in alignment with the guiding principles and
2) provision of some narrative to clarify common issues of uncer-
tainty or ambiguities experienced by pump clinics. The revised
clinical criteria to start IPT are presented in 3 sections: 1) Indica-
tions, 2) Qualifications and 3) Requirements. The CAC also recom-
mended that pump therapy be considered not only for individuals
with T1D (1,2) but also those with insulin-deficient diabetes (e.g.
type 3C diabetes) (4), because they face similar challenges in safely
achieving optimal glycemic control.

Methods
The CAC is a multidisciplinary group comprising health-care
professionals with substantial expertise in IPT and includes adult
and pediatric endocrinologists, an internist, a pediatrician, certified
pump trainers and diabetes educators (both registered nurses and
dietitians) and clinical managers from across Alberta (listed in
Supplementary Appendix). The group meets regularly by telecon-
ference. Together, the CAC developed consensus recommendations
based on best practice and literature review, integrated with
1). Indications for insulin pump therapy: The clinical indications for
IPT are presented in Table 1. Clearly defining the indication for
therapy is necessary to permit a meaningful assessment of the
effectiveness of the intervention, particularly because the
definition of success will differ depending on indication. The
criteria are listed in 4 hierarchical levels. The hierarchy was not
defined primarily to attribute relative values to the indications,
but rather to help prioritize in situations in which capacity to
start pumps is limited.
Level 1 indications were believed to represent the strongest
indications—either because of clinically significant risks from
 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235 231

Table 1 second-generation basal analogues, which have significantly low-

Indications for insulin pump therapy ered the risk for nocturnal hypoglycemia (8,9), IPT may remain a
Level 1 better option for some individuals, particularly if unpredictable
1.1 Problematic hypoglycemia Two or more episodes of severe activity or frequent participation in physical activity or sports
hypoglycemia in the past 12 require temporary basal rates.
months or 1 episode in the past 12
months associated with impaired
Level 3 indications primarily reflect the preferences of persons
awareness of hypoglycemia, with diabetes. Treatment satisfaction is generally superior and
extreme glycemic lability or major multiple aspects of quality of life improve with IPT compared with
fear and maladaptive behaviour MDI (10,11). Patient preference is recognized by the CAC as an
(18)
important factor to be considered.
1.2 Hypoglycemia unawareness Indicated by a Clarke et al (21) or
Gold et al (14) score 4/7 Level 4 was identified to allow for clinical exceptions in cases
1.3 Inability to achieve acceptable With flexible insulin therapy using where pump therapy may be valuable for individuals who did not
glycemic control * multiple daily injections meet other indications (e.g. needle phobia, adults with very low
1.4 Development and progression When glycemic control is insulin requirements, marked glycemic variability, planning of or
of microvascular complications inadequate *
Level 2
during pregnancy, gastroparesis, insulin allergy), or may be unable
2.1 Unpredictable variation in When ability to adjust basal insulin to satisfy usual requirements (described in what follows). It was
activity levels delivery is required to improve recommended that additional mechanisms be put in place to ensure
glycemic control or minimize risk this indication was appropriate, including a second opinion from
of hypoglycemia
another pump centre/prescriber before initiation, and earlier re-
2.2 Strong dawn phenomenon When increases to basal (analogue)
insulin to achieve fasting glucose evaluation to determine whether IPT had been safe and effective.
targets have caused nocturnal
hypoglycemia 2). Qualification criteria required to start insulin pump therapy: The
2.3 Age <12 years and multiple It may not be possible to make qualifying criteria are presented in Table 2. These criteria were
daily injections are considered sufficiently small adjustments to
impractical or inappropriate insulin doses when given by
developed in response to the experience of pump centres
injection in very small, insulin- managing referrals of individuals who had not received adequate
sensitive children diabetes self-management education or if the expectations (of
Level 3 persons with diabetes or their provider) of IPT were unrealistic.
3.1 Strong desire/motivation for In patients achieving acceptable
The criteria were also informed by recent evidence underscoring
pump therapy control with flexible insulin
therapy using multiple daily the primacy of education and training as prerequisites for
injections successful IPT (12). The minimum education required previously
3.2 Current/previous pump user With acceptable glycemic control * for applicants to watch a narrated online presentation and
Level 4 complete a quiz was not sufficient for safe and effective self-
4.1 Clinical exception When IPT is required to mitigate
risk from extremely poor glycemic
management.
control (e.g. due to severe needle The provision of intensive education and support was the most
phobia) or prevent recurrent important factor to reduce severe hypoglycemia in a clinical trial,
hospital admission, and alternative regardless of whether subjects were randomized to IPT or MDI (12).
approaches have been exhausted or
Furthermore, a recent randomized clinical trial demonstrated that
judged inappropriate
MDI and IPT were equally effective for glycemic control when
IPT, insulin pump therapy. people received education and training in flexible insulin therapy,
* Acceptable or optimal glycemic control will be individualized as recommended
by current clinical practice guidelines and will depend on the clinical context, such
although IPT did have some advantages for important patient-
as age, pregnancy, comorbidities and life expectancy. reported outcomes, including treatment satisfaction, dietary
freedom and daily hassle (13).
These trial data align with the experience of pump centres (and
severe hypoglycemia or microvascular complications resulting the previous evaluation) (3) who found that, after education and
from inadequate glycemic control, which may be considered as appropriate use of insulin analogues, some individuals no longer
failure of conventional therapy. The strongest evidence for the wished to start IPT. In Alberta, an online learning course is available
effectiveness of pump therapy to reduce hypoglycemia or improve (https://myhealth.alberta.ca/learning/insulin-pump-therapy) as
hyperglycemia is seen in those at highest risk (frequent severe well in-person classes that cover all major clinical and technical
hypoglycemia or high baseline A1C, respectively) (5). These rec- aspects of pump therapy. Because of the costs of IPT, it also seemed
ommendations align with international guidelines (6). appropriate to require an adequate trial of MDI using insulin ana-
Level 2 indications describe clinical situations in which pump logues with the principles of flexible insulin therapy. Exceptions to
therapy could reasonably be considered superior to most current this requirement may exist if MDI is not feasible.
basal insulins, or in young children, in whom smaller dose incre-
ments are required than can be achieved with injections. These
Table 2
indications would generally be considered best practice recom-
Qualification criteria for insulin pump therapy
mendations. Although there is less available evidence for effec-
tiveness of pump therapy to reduce A1C or hypoglycemia in Required factor Descriptors
pediatrics, there are clear practical advantages, which have been 1. Successfully completed type 1 . and demonstrated competence in
recognized in international guidelines (6). Although IPT is intui- diabetes education flexible insulin therapy and/or
tively attractive to address the dawn phenomenon, this was not strategies to prevent severe
hypoglycemia
demonstrated in a recent, relatively small (n¼40), 8-month obser- 2. Adequate trial of flexible insulin . supervised by an experienced
vational study. That study showed no reduction in the occurrence of therapy with modern insulin multidisciplinary team
the dawn phenomenon, but did identify an increased risk for analogues
hypoglycemia in pump users who programmed an increase in early 3. Actively involved in diabetes self- . as evidenced by ability and
management willingness to participate in a number of
morning basal rates (7). Finally, although the advantages of IPT for
self-care behaviours (Table 3)
basal insulin delivery may have diminished since the advent of
232 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235

The requirement for active involvement in diabetes self-
management was 3-fold: to address a common misconception
(among patients and referring health-care professionals) that a
pump would function autonomously, to ensure that individuals can
gain the most value from their pump and to ensure patient safety.
Previously, criteria were satisfied through assessment of behav-
iours, such as blood glucose monitoring (4 times per day) and
attendance at appointments, as well as management and problem-
solving skills. However, a full review of competence in all education
topics needed for safe and effective self-management of T1D was
not required. Subsequently, significant gaps in education and
management emerged relating to topics such as exercise, eating
out, drinking alcohol and sick-day management.
Typical indicators of active self-management behaviours are
listed in Table 3. The CAC sought to provide a framework describing
typical expected behaviours that should be sustained to ensure
safety and optimal outcomes, rather than defining arbitrary
thresholds achieved only to qualify for IPT and then abandoned.
Submission of blood glucose, insulin doses and food records is
invaluable for determining initial pump settings, but also provides
supportive evidence of competence in flexible insulin therapy.
Requests can be made to waive 1 or more of the qualification criteria.
3). Requirements for starting insulin pump therapy: The Alberta Pro-
vincial IPT Program requires approval by an authorized pump pre-
scriber (a medical doctor or nurse practitioner) and initiation by an
approved pump clinic, staffed by an interprofessional team with
expertise in IPT. Pump centres must be confident that individuals
have:

Completed work with a diabetes team, ideally containing a
registered nurse and dietitian to permit accurate assessment of
starting basal rates, insulin:carbohydrate ratios and insulin
sensitivity.

Completed training and demonstrated technical competence
with their selected pump to ensure safe use.
In some cases, this work may have been completed already by
the pump clinic while assessing whether qualification criteria were
met. Conversely, there is no requirement that all aspects of training
must be delivered exclusively by approved pump clinics. Previously,
some centres required individuals to repeat training that had been
completed elsewhere—consuming capacity and adding frustration
for applicants.
Insulin pump therapy periodic review and criteria for continuation
Many people with T1D receive their routine diabetes care from
family physicians and chronic disease management teams and live a
long way from authorized pump centres (Figure 1A). The CAC was
concerned that a requirement for in-person annual review by an
approved pump centre was burdensome for patients and required
clinic capacity that would be difficult to sustain. Nevertheless, the CAC
recommended some form of periodic review as essential to ensure
patient safety and maximize the clinical benefits of IPT for individuals
enrolled in the provincial program. The goal of the review process is to
help maintain people on IPT by providing ongoing education, support
and coaching, and to promote active self-management:

At minimum, a review at 1 year after initiation in the Provincial
IPT Program and at 5 years (or before replacement pump) is
required (Alberta Health has maintained the requirement for
annual reviews).

More frequent review is required if expectations are not being
met or concerning factors arise or are identified (described in
what follows).

The review may be done in-person or remotely (e.g. via tele-
health or teleconference).

For experienced pump users with glycemic control in the target
range, no severe hypoglycemia and meeting expectations, this
may simply consist of a self-assessment (Supplementary
Figure 2) and pump upload.
Expectations for insulin pump users
The CAC concluded that it would be helpful for both pro-
fessionals and pump users if expectations to ensure safe and
effective pump therapy were made explicit. These expectations are
for pump users to:
1. Regularly follow up with a doctor (e.g. family physician), or
other health-care professional, for routine diabetes care (reg-
ular A1C, surveillance for complications).
2. Demonstrate active involvement in diabetes self-management
(Table 3).

Table 3
Active self-management behaviours—typical indicators
For all people with type 1 diabetes
Carbohydrate counting or following
another recommended meal-planning tool
Monitor blood glucose frequently and
consistently using capillary blood
glucose monitoring and/or continuous
or flash glucose monitoring (usually
this would require 4 tests per day,
before meals and at bedtime)
Consistently taking insulin as directed
(using basal and meal-time insulin for
people on MDI, and consistently
bolusing for meals and snacks for
“pumpers”)
Adherent with follow up—which includes
attending clinic visits, completing A1C
tests and completing required
documentation (e.g. blood glucose logs,
food records)
A1C, glycated hemoglobin; MDI, multiple daily injections.
Additional behaviours for
people using insulin pumps
Performing regular infusion
set/site changes.
Appropriately using the smart
features of the insulin pump
Safely managing their pump to
minimize risks of hypoglycemia
or diabetic ketoacidosis
Concerning factors
The CAC identified several factors that may raise concerns
regarding the safety or effectiveness of pump therapy (Table 4).
These may identify areas where additional education or support is
required to ensure appropriate, optimal and safe use of IPT. More
frequent review by the diabetes team and/or pump clinic would be
recommended if any of these are present.
Discontinuation from provincial IPT program
For individuals who remain eligible for Alberta Health Care,
discontinuation from the Provincial IPT Program may occur if they
no longer wish to continue using IPT, or when its continuation is
considered unsafe. Pump prescribers and centres may consider
costs (financial and opportunity) when deciding on whether IPT
should be continued. An open discussion involving the patient/
family is recommended.
The CAC identified several factors that may indicate continued
use of IPT is unsafe and that discontinuation from the Provincial IPT
 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235
Table 4
Concerning factors suggesting need for additional education and/or support
Increase in glycated hemoglobin of >1.5% from baseline, or to levels >10%
Recurrent admissions to hospital for diabetic ketoacidosis
More than 1 episode of severe hypoglycemia in a 12-month period
Failure to engage consistently in active self-management (Table 3)
Excessive basal rates associated with risk for hypoglycemia if meals are omitted
or delayed
Physical, psychological or cognitive deficits, or changes in social situation, where
the individual (or family) may find it more challenging to manage pump
therapy safely
Program should be considered (Table 5). Patients discontinued
from IPT should continue to be followed by a diabetes care team. A
full reassessment would be required if they aimed to re-enrol in the
Provincial IPT Program.
Special situations
The CAC identified some situations in which additional guidance
would be helpful.
Transitioning young adult pump users: Transition from pediatric to
adult diabetes care is challenging. In many cases, the initial IPT
education may have been provided to caregivers, rather than the
individual living with T1D. Therefore, an assessment of the indi-
vidual’s knowledge and skills related to IPT, independent of their
caregiver, before transfer to adult care, should be performed and
gaps addressed. The CAC considered it helpful for young adults to
participate in pump training directed at adults around flexible
insulin therapy, carbohydrate counting, meal planning and
advanced pump use, to ensure they have the requisite skills to
safely and successfully manage their pump independently.
The CAC recommended that adequate time be allowed for suc-
cessful completion of new insulin pump starts or pump renewals
(at 5 years) before being discharged from pediatric care.
Existing pump users wishing to join the provincial IPT
program: Existing pump users whose current pump was pur-
chased privately, through a private drug plan or who have moved to
Alberta from another jurisdiction, will required to undergo
assessment by an approved pump centre to ensure that eligibility
and continuation criteria are met and will be required to satisfy the
IPT qualification criteria (Table 2, except for an adequate trial of
flexible insulin therapy) and requirements for pump initiation
(described earlier). The CAC recommended that, in general, these
individuals should be encouraged to participate in pump
education/refresher courses to facilitate optimal self-management
and smooth enrolment in the provincial program.
Quality assurance and evaluation framework
The CAC recognized that safe, appropriate and responsible
prescribing of IPT needs to be demonstrated. Forms were devel-
oped (Supplementary Figures 1, 2 and 3) to capture key data as the
Table 5
Factors suggesting discontinuation of pump therapy be considered
Persistent failure to meet expectations of IPT users
Persistent failure to demonstrate engagement with diabetes self-management
(Table 3)
Unwilling to work with diabetes and/or pump team to address concerning
factors (Table 4)
Unwilling to maintain engagement with pump program when this is clearly
associated with risk of harm
When continuation of IPT would be unsafe
When the patient (or family) is unable to safely operate and/or manage IPT
Illegal or unethical behaviour (e.g. reselling supplies)
IPT, insulin pump therapy.
233
basis for an evaluation framework, but which would also be valu-
able for day-to-day operations.
The Insulin Pump Start Form (Supplementary Figure 1) captures
the indication for IPT, the most recent A1C values and the indi-
vidualized A1C target (and reason).
A Self-assessment and Declaration Form (Supplementary
Figure 2) was developed to reduce the burden of in-person
annual review, free up capacity to support those in greatest need
and promote self-reflection and self-efficacy. This form also cap-
tures key patient-reported safety parameters (severe hypoglyce-
mia, diabetic ketoacidosis and hypoglycemia awareness) (14).
The Pump Review Form (Supplementary Figure 3) was designed
to capture key data to evaluate the effectiveness and safety of pump
therapy. Current A1C, frequency of severe hypoglycemia and dia-
betic ketoacidosis, hypoglycemia awareness, participation in reg-
ular medical follow up, engagement in self-management or
presence of unsafe behaviours are captured, and alert values
defined for each of these parameters. The reviewer is then asked to
make an overall assessment and address (or formulate a plan to
address) any deficiencies identified. In addition to providing key
data elements for program evaluation, this form offers a framework
for conversation and self-management support.
Two additional recommendations were made by the CAC.
Because of the need for individualized assessment and a significant
reliance on clinical judgement, regular provincial case conferences
and quality improvement rounds should be held to facilitate peer
support and learning, and to ensure consistent, best practice across
the province. The CAC also recommended that an electronic data-
base be established to capture provincial IPT program data. By
linking a database to provincial claims (hospital admissions and
physician billing claims) and laboratory data, post hoc analysis of
the impact of pump therapy on health-care utilization, glycemic
control, cost-effectiveness, interactions with socioeconomic factors
and potentially (over the longer term) progression of complications
(e.g. changes in incidence of albuminuria, decline in estimated
glomerular filtration rate and treatments for retinopathy) would be
facilitated. It could also automate the identification of individuals
with hypoglycemia or diabetic ketoacidosis who may require
additional education or support in close to real time.
Discussion
In this study, we have described the process and rationale for
revision of the clinical criteria for participation in the Provincial IPT
Program in Alberta. The major shifts have been in defining the
indication for pump therapy in the revised criteria (which are listed
hierarchically to assist with prioritization) and removing an arbi-
trary A1C threshold (which had, unintentionally, become the
dominant criterion). The emphasis on T1D education as a key
element regardless of mode of insulin delivery and a prerequisite
for pump therapy aligns with current literature and a philosophy of
promoting self-management. The revised criteria provide a
framework for ongoing evaluation of both safety and effectiveness.
A unique element of Alberta’s revised criteria is the recording
and tracking of the indication for IPT, which have been categorized
hierarchically. Our qualification and requirements for pump ther-
apy are, in essence, similar to those of other Canadian provinces
(with requirements for blood glucose monitoring, participation in
education and follow up). However, this document is unique in
providing a clear description not only of the purpose and rationale
for the criteria and how they align with the programs overarching
objectives, but also to provide a framework that goes beyond a
functional, quantitative assessment of tasks (e.g. 4 blood glucose
tests per day) toward one designed to assess and build compe-
tencies and promote safe and healthy behaviours (e.g. demon-
strates active involvement in self-management) around IPT. Our
234 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235
previous criteria (and published criteria from other provinces) may
have been interpreted as a tool to restrict or remove access to IPT,
whereas the revised criteria aim to promote safe and effective use
of IPT as part of an overall strategy to promote effective self-
management.
This document represents an integration of knowledge from
published literature and international guidelines, combined with
clinical expertise and a pragmatic approach to resolving real-world
problems. As such, we believe this working document will be of
great practical value for clinics, programs and planners.
Much of the earlier literature has described retrospective
observational data, clinical trials, meta-analyses or health tech-
nology assessments, which sought to summarize the literature to
determine clinical benefits and/or cost-effectiveness. The fairly
marginal improvements in glycemic control associated with
pump use reported in meta-analyses of randomized controlled
trials (10) at first appear to contradict the enthusiasm described
by clinicians and people living with diabetes, where the benefits
of IPT are most clearly reflected in superior treatment satisfaction
(12), diabetes-specific quality of life and less fear of hypoglycemia
(13). Others have highlighted that clinical benefit will be under-
estimated by the inclusion of low-risk subjects (5). A meta-
analysis of trials selecting patients with a high baseline rate of
severe hypoglycemia showed that the use of IPT was associated
with a clinically relevant decrease in severe hypoglycemia epi-
sodes (15), with the greatest reductions seen in participants with
the highest initial rates. Similarly, patients with higher A1C at
baseline have demonstrated the greatest improvement in glyce-
mic control as a result of using IPT (15e17).
Furthermore, the decision to use or recommend IPT is often in
response to limitations, or perceived failure, of MDI. Thus, careful
patient selection and education appear to be key components for
subsequent successful pump therapy. The REPOSE trial highlighted
the importance of self-management education for persons with
T1D, regardless of mode of insulin delivery (13). In the absence of a
clinical indication or personal preference for pump therapy, struc-
tured education in flexible insulin therapy was associated with
improvement in A1C at 24 months (0.6%, on average, for those with
an initial A1C of >7.5%) and a 50% reduction in severe hypoglycemia
rates, irrespective of randomization to pump or MDI; treatment
satisfaction and quality of life, however, were better in the group
allocated to pump therapy (13). Therefore, we recommend priority
be given to the provision of structured education in flexible insulin
therapy for all those with T1D.
We recognize that this document is not a systematic literature
review or evaluation of cost-effectiveness. Nevertheless, we believe
it aligns with recommendations from the UK National Institute for
Health and Care Excellence, which also identified the need to
incorporate the perspective of clinical experts and a broad range of
stakeholders, among them patient experts (6). Other consensus
groups have highlighted a primary role for educational interven-
tions before advancing to IPT for problematic hypoglycemia (18)
and before advancing to therapies incorporating continuous
glucose monitoring (sensor-augmented pumps) (19), which is not
publicly funded in Alberta currently.
It is important to acknowledge that the CAC was composed of
health-care professionals and there was no formal representation
from people living with or affected by diabetes in the review pro-
cess—a deficiency that will be addressed in the future. The CAC
recognizes that the evaluation framework is focused largely on
biologic outcomes, which may not adequately capture outcomes
that are most important to persons with diabetes. The CAC further
recognizes that A1C is an imperfect proxy for glycemic control, and
other outcome variables (e.g. time in range) may emerge in the
future (20). Finally, issues of equity and access should be formally
evaluated, with particular attention to populations that may face
additional barriers to IPT, including matters relating to literacy,
numeracy, visual or other impairments, as well as ensuring that
language proficiency is not a barrier to accessing high-quality
educational tools and self-management support.
To our knowledge, Alberta is the only province with a CAC
providing strategic advice for a pump program. We believe this is an
important function and has been of value to the Ministry of Health,
people living with diabetes and health-care providers. We also
believe that these revised clinical criteria, with clearly stated expec-
tations and a streamlined review and evaluation process, will help
promote safe and effective pump therapy to deliver optimal care and
good value for the money in Alberta. The evaluation framework will
allow regular reporting and serve as a basis for quality assurance and
improvement. This description of the process and structure of an
effective partnership between clinicians, payers and policymakers
can serve as a valuable model for other jurisdictions. Future work
should not only assess whether these revised criteria have assisted in
the safe and effective adoption of IPT in Alberta, but also when
compared with other provinces throughout Canada.
Supplementary Material
To access the supplementary material accompanying this article,
visit the online version of the Canadian Journal of Diabetes at www.
canadianjournalofdiabetes.com.
Author Disclosures
K.Y., B.M. and S.C. are employees of Alberta Health Services.
P.A.S. serves in several volunteer roles in Diabetes Canada,
including past chair of the Professional Section Executive, chair of
the Clinical Practice Guidelines Steering Committee and member of
the board of directors. He is co-lead of the Innovations in Type 1
Diabetes Goal Group in Diabetes Action Canada (a patient-oriented
research organization). Before 2015, he received consulting fees
from Animas, Insulet and Medtronic, having marketed insulin
pumps in Canada. The work of the Alberta Provincial Insulin Pump
Therapy Program Clinical Advisory Committee was conducted
within the scope of the authors’ employment with Alberta Health
Services and service agreements with the Alberta Academic Med-
icine and Health Services Program, or on a voluntary basis.
Author Contributions
D.H. prepared the first draft of the manuscript. P.A.S. conceived
and oversaw all stages of the manuscript and acts as guarantor. All
authors provided critical review of drafts and approved the final
manuscript.
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235.e1 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235

Supplementary Appendix

Provincial Insulin Pump Therapy Program Clinical Advisory Committee:

Name Role/affiliation

Bev Madrick Education consultant, Endocrinology & Metabolism Program,

Calgary, AB
Bonny Erickson Bariatric diabetes specialty clinic coordinator, Grande Prairie,
AB
Daniele Pacaud Pediatric endocrinologist, University of Calgary, Calgary, AB
Debbie Hodder Unit manager, Kaye Edmonton Clinic, Edmonton, AB
Mark Mahood Pediatrician, Red Deer, AB
Elizabeth Pediatric Endocrinologist, University of Alberta, Edmonton, AB
Rosolowsky
Jane Cresswell Registered nurse, diabetes clinic, Lethbridge, AB
Julia Mercer Registered dietitian, certified diabetes educator, Calgary, AB
Julie McKeen Endocrinologist, University of Calgary, Calgary, AB
Karen Smilski Alberta Health, Edmonton, AB, ex officio
Stephanie Alberta Health, Edmonton, AB, ex officio
Minnema
Kim Young Registered dietitian, provincial practice lead, Nutrition
Services, Alberta Health Services, Edmonton, AB
Lisa Huggins Registered nurse, certified diabetes educator, Edmonton, AB
Lorelei Registered nurse, certified diabetes educator, provincial IPT
Domaschuk program coordinator, Lacombe, AB
Michelle White Registered dietitian, certified diabetes educator, Fort
McMurray, AB
Robert Burris Internist, Grande Prairie, AB
Peter Senior Endocrinologist, University of Alberta, Edmonton, AB
Sue Conroy Senior provincial director, provincial clinical programs,
Alberta Health Services, Edmonton, AB
Peter Sargious Medical director, Diabetes, Obesity, Nutrition Strategic Clinical
Network, Alberta Health Services, Edmonton, AB
Tanya Patient care manager, Stollery Diabetes Clinic, Edmonton, AB
Cruickshank
 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235 235.e2

Insulin Pump Therapy Program - Start Form

Must Indicate Level
Indication for Pump Therapy
Provide the primary indication from Section 4.1 in IPTP Clinical Criteria:
(Level 1.1 – 4.1)
Must Select “YES” or “NOT APPLICABLE” for every item

Not
Qualification Criteria Met (IPTP Clinical Criteria Document 4.2): Yes Applicable
a) Successful completion of:
Diabetes management education
Pre-insulin pump information session
Demonstrated competence in Flexible Insulin Therapy (FIT)
Strategies to prevent severe hypoglycemia
b) Adequate trial of FIT with modern insulin analogs supervised by an
experienced multidisciplinary team.
c) Active involvement in diabetes self-management.
d) Patient assessment at the Approved IPT Clinic.

Additional Support for Approval / Other Clinical Factors:

Rationale for CLINICAL EXCEPTION or WAIVER of qualifications to be recorded here. Discussion at a
case conference or second opinion from another pump prescriber could be documented here as a
marker of due diligence.

Must indicate
YES” or “NO”.

If Yes: Must include “Physician Name” Must include

Clinic Team
Member
Approvers: “Name”
Insulin Pump Therapy Program
“Signature” AND
Insulin Pump Therapy Program Clinic Team Member “Date”
Physician Approval Name:
No Signature:
Physician Name: Date:
Pump Centre:
Must include Name of “Pump Centre”

Additional Information (for program evaluation purposes):

Most Recent A1C Result: Date:

Must include: “Most Recent A1C Result” AND “Date” of the Lab Test

Supplementary Figure 1. Pump Start Form. (Note: “Physician” would be better labelled as “authorized pump prescriber,” which may include nurse practitioners or other health-
care professionals, depending on provincial legislation.)
235.e3 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235

Supplementary Figure 2. Annual Self-assessment and Attestation Document (https://www.albertahealthservices.ca/assets/programs/ps-1061556-iptp-participant-self-assess

ment-questionnaire.pdf).
 D. Haddadi et al. / Can J Diabetes 45 (2021) 228e235 235.e4

Insulin Pump Therapy Program - Review Form

Insulin PumpTherapy Participant Self-Assessment Questionnaire Received: Yes No
Comments: Must Select Method(s) of the review – it might have Must Select
occurred by more than one method. Check ALL that apply. “YES” or
Method of Review: “NO”
whether
In Person Remote: Written Correspondence Video Telephone clinic
received
Self -
Elements to Review: Assessment
Yes No Form from
A1c >10% or increased by > 1.5% paent/
caregiver
Severe Hypoglycemia two or more times/year Must
DKA admission two or more times/year Select
“YES”
Hypoglycemia unawareness
or
Inadequate medical follow up “NO”
Inadequate engagement in self-management for
every
Excessive basal rates Element
Physical, psychological, or cognive deficits

Comments:

Assessment Summary:
Must Doing well, no concerning features
select
1 of 4
Satisfactory, minor concerns identified
options Concerning features requiring further work and in person follow up
To be disconnued from IPTP
Must indicate if paent was
Actions for Follow-up: reviewed by an IPTP physician
by selecting “YES” or “NO”.
Not a mandatory Must include “Name”
field (there may If Yes: must include AND “Signature” of
or may not be “Physician Name” Clinic Team Member
documentation) who completed
Patient Review

Reviewedby: Insulin Pump Therapy Program

Insulin Pump Therapy Program Clinic Team Member:
Physician: Name:
Yes No Signature:
Physician Name: Date:
Pump Centre:
Must include Name of “Pump Centre” and “Date” of review
d

Supplementary Figure 3. Pump Review Form. (Note: “Physician” would be better labelled as “authorized pump prescriber,” which may include nurse practitioners or other health-
care professionals, depending on provincial legislation.)