DIABETES TECHNOLOGY & THERAPEUTICS

Volume 18, Number 3, 2016

Mary Ann Liebert, Inc.
DOI: 10.1089/dia.2015.0240

ORIGINAL ARTICLE

Evaluation of the Adherence to Continuous Glucose

Monitoring in the Management of Type 1 Diabetes
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.

Patients on Sensor-Augmented Pump Therapy:

The SENLOCOR Study
Sylvie Picard, MD, PhD,1 Helene Hanaire, MD, PhD,2 Sabine Baillot-Rudoni, MD,3
Elisabeth Gilbert-Bonnemaison, MD,4 Didier Not, PhD,5
Yves Reznik, MD, PhD,6 and Bruno Guerci, MD, PhD7

Abstract
Background: Continuous glucose monitoring (CGM) and sensor-augmented pump (SAP) therapy improve
glucose control provided good adherence. In France, not only diabetologists, nurses, and dieticians but also
nurses employed by homecare providers (HCPNs) are together involved in the initiation and/or follow-up of
continuous subcutaneous insulin injection (CSII) and SAP training. The SENLOCOR Study is an observational
study designed to assess SAP adherence over 6 months (primary objective). Secondary objectives included the
impact of SAP on metabolic control and patients satisfaction.
Materials and Methods: CGM initiation (M0) was performed within 3 months after CSII. CGM adherence,
defined by sensor wear >70% of the time, glycated hemoglobin (HbA1c) levels, and satisfaction questionnaires
were collected at inclusion and at 3 (M3) and 6 (M6) months.
Results: The analysis population was 234 patients, including 27 children. Of the physicians, 88.0% were involved in
SAP education for the whole cohort (median time, 45 min), whereas HCPNs were involved in CGM training for 190
patients (81.2%) (median time: at M0, 156 min; at M3, 20 min). Good adherence was obtained in 86.1% (M0M3)
and 68.9% (M3M6) of the patients. The HbA1c level decreased from 8.16 1.35% (M0) to 7.67 1.01% (M6) in
189 patients (change, -0.48%; 95% confidence interval, -0.64, -0.33). The percentage of patients who experienced
severe hypoglycemia decreased from 20.7% (M0) to 13.6% (M3) and 13.3% (M6). Satisfaction scores were high.
Conclusions: In patients with type 1 diabetes, a 6-month training on SAP involving a multidisciplinary team,
and especially HCPNs, improved metabolic control with a high level of adherence and satisfaction.

Introduction decide the best way of delivering basalbolus therapy:

multiple daily injections (MDI) or continuous subcutaneous

S ince the Diabetes Control and Complications Trial

study, basalbolus therapy is considered as a gold stan-
dard therapy for patients with type 1 diabetes (T1D). Ten
years ago, the question facing a patient with T1D was to
insulin infusion (CSII). More recently the question has
emerged whether continuous glucose monitoring (CGM) is a
reliable and beneficial tool for reaching glucose targets and
preventing hypoglycemia in patients using sensor-augmented

1
Point Medical, Rond-Point de la Nation, Dijon, France.
2
Endocrinology-Diabetes Care Unit, Toulouse University Hospital, Toulouse, France.
3
Endocrinology-Diabetes Care Unit, Dijon University Hospital, Dijon, France.
4
Endocrinology-Diabetes Care Pediatric Unit, Tours University Hospital, Tours, France.
5
Center of Clinical Research, Lyon, France.
6
Endocrinology-Diabetes Care Unit, Caen University Hospital, Caen, France.
7
Endocrinology-Diabetes Care Unit, University of Lorraine, Vandoeuvre Les Nancy, France.
The members of the SENLOCOR Study Group are listed in Appendix 1.

127
 128
pump (SAP) therapy. The efficacy of CGM was demonstrated
in randomized controlled trials (RCTs) provided patients used
the sensor at least 70% of the time over a 6-month period.1
In France, CSII therapy ought to be started in pump-
specialized diabetes centersmore than 180 in 2007.2 Multi-
ple health professionals are involved in patients training
such as diabetologists and members of the diabetes team
(nurses, dieticians). The technical part is initiated and/or
followed by a nurse employed by a homecare provider (HCP).
HCPs provide pump technical support and deliver infusion
sets according to the physicians prescription and the pa-
tients needs. They visit the patient at least twice a year to
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.
download pump data and report to the diabetologist. More
recently, some HCP nurses (HCPNs) have been involved in
CGM technology to train and/or follow up patients, although
no reimbursement has been obtained for CGM from French
health authorities yet. CGM training is time consuming for
the medical team but is crucial as it could influence patient
adherence and thus efficacy.
The SENLOCOR study is the first observational study that
was designed to assess as a primary objective the adherence
over a 6-month period to SAP therapy (initiated less than 3
months after CSII) in patients trained and/or followed up by a
medical team and HCPs all together. It implements SAP into
real-life practice involving an initial patients training by the
usual diabetes care team and, for the first time, a subsequent
home follow-up by HCPNs. Secondary objectives included
the evaluation of its impact on metabolic control as well as
the patients satisfaction.
Patients and Methods
Recruitment
The protocol of the study has been approved by local health
authorities as well as the French national agency for the
protection of personal computerized data (agreement number
DR-2011-029). Patients were recruited by diabetologists
(75%) or pediatricians (25%) while they had started CSII for
less than 3 months.
Inclusion criteria
Male and female T1D patients on intensive treatment
could be included whatever their age (adults or children
under 18 years of age) if they were treated with MDI, if they
performed three or more self-monitoring of blood glucose
(SMBG) tests per day, and if they were prescribed CSII and
were to be CGM users according to the French guidelines.3,4
Informed consent was obtained from the patients and the
childrens parents.
Exclusion criteria
Exclusion criteria included pregnancy starting more than 3
months before inclusion, active retinopathy, progressive co-
morbidities, visual or hearing impairment (preventing the patient
from seeing or hearing the alarms), and psychiatric disorders.
Study design
Enrollment in the study was performed within 1 week
before or after CGM initiation and was considered as baseline
(M0). Observance was defined by the sensor wear and was
expressed as the actual number of minutes (or the percentage
PICARD ET AL.
of minutes) when the sensor was actually worn. Adherence
to CGM, defined as the use of the sensor >70% of the time
when downloading the pump data (Carelink Pro; Med-
tronic, Minimed, Inc., Northridge, CA) together with gly-
cated hemoglobin (HbA1c) level and satisfaction rating were
reported at M0, 3 months (M3), and 6 months (M6). CSII
initiation was performed with Medtronic pumps, and Enlite
(Medtronic) sensors coupled with a Minilink (Medtronic)
transmitter were used for CGM. Almost all the patients were
on the VEO (Medtronic) system (two were on the Para-
digm [Medtronic] system).
The basic education for SAP use was provided by the
physicians and/or the diabetes team in hospital-based centers.
Then the HCPNs took over the patient education and SAP
practice back home (Appendix 2).
HbA1c measurement was performed at the patients local
laboratory. During the study, patients were allowed to call their
referring diabetes team, and the number of calls per patient was
recorded.
Questionnaires and data collection
Questionnaires were completed by the patient and the HCP
team at M0, M3, and M6. The M0 questionnaire was sent by the
patients within 6 days after CGM initiation. Satisfaction scales
were scored on a 5-point Likert scale, with 5 representing the
most positive response and 1 the most negative response.
Metabolic efficacy was defined as an HbA1c value of <7.5% or
an HbA1c diminution of >1.0%. Differences in adherence
according to the interval between CSII and CGM initiation
(more than 7 days vs. 7 days or less) were analyzed.
Statistical methods
Statistical analyses were conducted with SAS software
(version 9.2; SAS Institute, Cary NC). The analyses were
performed on patients with at least one follow-up visit avail-
able (3 or 6 months) and CSIICGM interval of >105 days. No
missing data were imputed.
Quantitative variables are expressed as mean SD or median
(Q1Q3). Qualitative variables are expressed as the number of
patients and percentages. For all analyses, the probability of a
type I error (a) was set at 0.05, and the confidence level was set
at 0.95 for two-sided tests.
Comparisons between patient subgroups were performed
using the v2 test for qualitative variables, Students t test or
analysis of variance for normal quantitative variables, and the
nonparametric MannWhitney or KruskalWallis test for
semiquantitative or quantitative variables with non-normal
distribution. Based on the finding that 60% of patients had a
recommended adherence to CGM (sensor wear >70% of the
time), 215 patients should be included to have a power of
80% to show an adherence of 70% (Type I error = 0.05 two-
sided and 15% of missing data). The definition of severe
hypoglycemia was the same as the one used in the Diabetes
Control and Complications Trial.5
Results
Physician population
In total, 79 physicians recruited the patients. Most physicians
were hospital based, with only 16 (21.3%) being office-based.
Two-thirds of the centers were located in large urban areas.
 ADHERENCE TO SAP THERAPY IN TYPE 1 DIABETES
Patient population
In total, 277 patients were included (Fig. 1). Among
them, 43 were excluded because the CSIICGM interval
was more than 105 days (n = 15) or because data from the
follow-up visit were not available. The per-protocol popu-
lation included 234 patients, of whom 27 were children.
Data were available for 227 patients at M3 and for 214
patients at M6. Characteristics of the analyzed population
and of the 28 patients who were lost to follow-up between
the inclusion and M3 are shown in Table 1, as well as the
characteristics of the patients who kept only one of the
follow-up visits: M3 or M6 (n = 27). The population char-
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.
acteristics of the children were a mean age of 11.0 4.3
years, diabetes duration of 3.9 4.0 years, and baseline
HbA1c level of 8.30 1.63%. The CSIICGM interval was
more than 7 days in 56% of the patients.
SAP initiation and training
CSII was initiated using a rapid-acting insulin analog (in
86.5% of the adults and 92.3% of the children) or human
regular insulin (13.5% and 7.7%, respectively). The median
interval between CSII initiation and inclusion was 22 days
(Q1Q3, -49.0 to 0.0 days) (in children, 3 days [-51.0 to
0.0 days]).
SAP training was performed by one care provider for
47.2% of the patients (HCPN, 34.8%; hospital diabetes team,
10.6%; diabetologist, 1.8%), compared with two and three
care providers for 35.4% and 17.2% of patients, respectively.
In 88.0% of the adult patients and 92.6% of the children, SAP
education was performed by physicians at M0 with a median
training time of 45 min (Q1Q3, 20.060.0 min) in the whole
cohort (in children, 22.5 min [10.052.5 min]). Training was
FIG. 1. Flow chart of the SENLOCOR study population.
CGM, continuous glucose monitoring; CSII, continuous
subcutaneous insulin infusion; M3, Month 3; M6, Month 6.
129
performed in adults and children orally (86.4% and 72.0%,
respectively), by written instructions (23.2% and 28.0%, re-
spectively), or by a brochure (57.1% and 36.0%, respec-
tively). HCPNs spent an additional 156 101 min for initial
SAP training at M0.
Overall, HCPNs were involved in the CGM training of 190
patients (81.2%), including 25 children (92.6%). They spent some
additional time, on average 29.3 27.4 min (median, 20.0 min;
Q1Q3, 10.045.0 min) at M3 for counseling (in children,
35.7 28.0 min; median, 30.0 min; Q1Q3, 10.060.0 min).
After CGM training, phone calls to physicians were re-
ported for adult patients and for children as 32.1% and 22.2%,
respectively, at M3 and 31.5% and 32.0%, respectively, at M6
with a frequency of phone calls per patient of 3.0 3.1% and
4.0 1.4%, respectively, at M3 and 3.4 4.8% and 2.8 1.8%,
respectively, at M6. The frequency of phone calls at M6 was
one to five phone calls for 87.7% of the patients and more than
10 times in one adult patient.
Status of patients according to CSII
and CGM use at M6
At M6, 166 patients (70.9%) currently used both CSII and
CGM, whereas 27 (11.5%) had withdrawn from CGM (six of
them at M3), and seven (3.0%) had withdrawn from both
CSII and CGM (two of them at M3). Status was not reported
for 34 patients (14.5%).
Among children, 14 (51.9%) currently used both CSII and
CGM at M6, whereas nine (33.3%) had withdrawn from
CGM (two of them at M3), and one (3.7%) had withdrawn
from both CSII and CGM (at M3). Status was not reported for
three (11.1%) young patients.
Primary outcome: adherence to CGM use
Recommended adherence to CGM (sensor wear >70% of
the time) was observed in 86.1% of the patients for M0M3
and 68.9% for M3M6 (Table 2), resulting in sensor wear at
the two study periods during 84.9 16.8% and 73.8 30.3%
of the time, respectively (Table 2). In the pediatric popula-
tion, adherence was obtained in 87.5% of the children for
M0M3 and 57.1% for M3M6. Among the patients who
kept the M6 follow-up (n = 214), poor adherence (<50% of
the time) was reported in only 11 patients (one child and 10
adults), whereas very good adherence (sensor wear >90% of
the time) was observed in 49.1% for M0M3 and 37.8% for
M3M6 of the patients (31.3% and 9.5% of the children,
respectively) (Table 2).
Secondary outcomes
HbA1c values. In the 189 patients complying with
HbA1c measurement at both baseline and M6, HbA1c dropped
from 8.16 1.35% to 7.67 1.01% (mean difference, -0.48
1.10%; 95% confidence interval, -0.64%, -0.33%). An HbA1c
level below 7.5% was obtained in 106 patients (56.1%) at M3
and 93 patients (49.2%) at M6 (12 children [50.0%] at M3 and
10 [41.7%] at M6). There were no correlations between ad-
herence to CGM and HbA1c variation at M3 or M6 (q = 0.12
and 0.07, respectively) or between SMBG frequency before
inclusion and HbA1c variation at M6. There was no difference
in HbA1c change between patients with a CSIICGM interval
at more or less than 7 days (data not shown).
 130 PICARD ET AL.

Table 1. Characteristics at Inclusion

Patients who performed Patients lost to
Analysis only one of the two follow-up (excluded
population follow-up visits from the analysis)
(n = 234) (M3 or M6) (n = 27/234) (n = 28/277)
Age (years) 37.9 15.4 36.4 13.7 39.9 17.0
Age at diagnosis (years) 21.2 12.9 22.2 14.4 22.6 13.9
Diabetes duration (years) 16.4 12.3 13.8 8.9 16.0 11.1
Gender female 109 (46.6) 11 (40.7) 13 (46.4)
BMI (kg/m2) 24.3 4.5 24.4 4.1 23.7 4.3
Waist circumference (cm) 88.8 14.3 88.9 12.5 88.3 14.4
Patients with 1 SH in the previous 6 months 46 (20.7) 7 (26.9) 3 (12.0)
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.

Mild hypoglycemia/week 3.0 (2.06.0) 3.0 (2.06.0) 2.5 (2.04.0)

DKA in the previous 6 months 1 0 0
Complications
Retinopathy 70 (30.6) 6 (22.2) 8 (29.6)
Nephropathy 23 (10.2) 1 (3.9) 4 (14.8)
Neuropathy 41 (17.9) 1 (3.7) 5 (18.5)
CVD 4 (1.7) 0 (0.0) 0 (0.0)
Stroke 4 (1.7) 0 (0.0) 0 (0.0)
Other vascular disease 7 (3.1) 0 (0.0) 0 (0.0)
HbA1c at baseline (%) 8.18 1.39 8.76 1.61 8.26 1.79
<7.0% 39 (17.7) 4 (16.0) 4 (14.8)
>8.0% 110 (50.0) 18 (72.0) 10 (37.0)
Insulin regimen before CSII
<3 injections/day 15 (6.6) 2 (7.7) 0 (0.0)
3 injections/day 212 (93.4) 24 (92.3) 28 (100)
Insulin total dose (units/day) 52.1 31.8 56.9 36.1 52.0 22.5
Patients using
Insulin pen 221 (98.2) 26 (100) 27 (96.4)
Syringes 4 (1.8) 0 (0.0) 1 (3.6)
Patients injecting occasionally correction bolus 133 (57.8) 16 (59.3) 15 (53.6)
SMBG tests per day 5.0 (3.06.0) 5.0 (3.06.0) 6.0 (4.08.0)
Data are mean SD values, n (%), or median (Q1Q3) unless otherwise specified.
CSII, continuous subcutaneous insulin infusion; CVD, cardiovascular disease; DKA, diabetic ketoacidosis; SH, severe hypoglycemia;
SMBG, self-monitoring of blood glucose.

Metabolic features. The proportion of patients who had
at least one severe hypoglycemia episode decreased from
20.7% in the 6 months prior to inclusion to 13.6% during
M0M3 and 13.3% during M3M6 in adults (in children,
from 25.0% to 11.1% and 11.8%, respectively). There
were only two hospitalizations for diabetic ketoacidosis
(one during the M0M3 period and one during the M3M6
period).
Patient satisfaction. Figure 2 show the patients satisfac-
tion scores about sensor use and SAP benefits in the manage-
ment of insulin therapy. Percentages indicate the proportion of
patients with a high or very high degree of satisfaction. Basi-
cally, main improvements in patients satisfaction related to
the prevention of asymptomatic hypoglycemia (48.7% at M0,
64.4% at M3, and 64.3% at M6), perception of less erratic
glucose values (46.4%, 60.0%, and 58.8%, respectively), and
treatment self-adaptations after CGM analysis (71.3%, 75.2%,
and 74.4%, respectively). Participants felt that diabetes was
easier to manage (85.0% at M3, 80.2% at M6) with more
appropriate reaction to hypoglycemia trends (77.7% and
70.5%, respectively) and better dosing of insulin (85.2% and
79.3%, respectively). The same trends were observed in the
pediatric population.

Table 2. Continuous Glucose Monitoring Observance and Adherence During the SENLOCOR Study
Sensor observancea Sensor wear adherenceb Sensor very good adherencec
Pediatric Total Pediatric Total Pediatric Total
population population population population population population
M0M3 83.3 13.4 84.9 16.8 87.5 (71.3100.0) 86.1 (81.091.3) 31.3 (11.058.7) 49.1 (41.556.8)
M3M6 59.5 34.0 73.8 30.3 57.1 (36.078.3) 68.9 (62.175.7) 9.5 (1.230.4) 37.8 (30.745.3)
Data are mean SD values or percentage (95% confidence interval), as indicated.
a
Percentage of the time with sensor wear.
b
Percentage of patients with sensor observance >70%.
c
Percentage of patients with sensor observance >90%.
 ADHERENCE TO SAP THERAPY IN TYPE 1 DIABETES 131
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.

FIG. 2. Satisfaction of the patients with continuous glucose monitoring and sensor-augmented pump use: (a) sensor use
and (b) sensor-augmented pump use. Satisfaction scales were scored on a 5-point Likert scale, with 5 representing the most
favorable response and 1 the most negative response. A scale of 100 is used for the graph. The Month 0 (M0) questionnaire
was actually administered 6 days after the first insertion of sensor. BG, Blood glucose; M3, Month 3; M6, Month 6.

Discussion is a key element, implying both technical and medical training

CGM has been used for several years and has proven its ef-
ficacy for improving glucose control in both adults and children
with T1D. However, barriers to CGM use can compromise good
adherence to sensor wear and therefore weaken CGM impact
on glucose control.6 The patients involvement in CGM and SAP
to help interpret and react to graphs and alarms.7 Such educa-
tion is time consuming for diabetes teams and HCPNs, who are
care providers recently involved in SAP training in France.
Most studies on SAP have focused on improvement of
metabolic control. The primary objective of the SENLOCOR
study was to assess patients adherence to SAP therapy over a
 132
6-month period in a real-life setting where patients were
trained and followed up by different care providers. Good
adherence, defined as sensor use >70% of the time, was ob-
tained in almost 81% of patients over a 6-month period.
Average sensor use in the present study was higher than in
others, including randomized controlled studies such as the
RealTrend study where only 69% complied with the >70% of
the time wear of the sensor.1 In the INTERPRET study, a 12-
month real-time SAP study including 263 patients who had
already used CSII for 2.6 3.0 years (baseline HbA1c of
8.1%), sensor use decreased from 37% during M0M3 to
27% during months 912.8 Actually, the first months of CGM
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.
use could be especially important as it appeared that after 1
year of SAP with sensor wear >60% of the time, patients could
maintain their HbA1c level while dropping the CGM wear to
only 40% of the time.9 These results suggest that long-term use
of CGM with good compliance should allow maintenance of
fair glucose control despite decreasing the percentage time of
CGM use. The decrease in adherence observed during M3M6
compared with the first M0M3 period might relate to the
patients feeling of better diabetes management with time and
the decrease in the need for further CGM data.
We did not observe a difference in adherence according to
CSIICGM time interval (more or less than 7 days), with the
CSIICGM time interval being less than 3 months according
to the study design. Other studies have reported a higher rate
of CGM use when it was started before CSII.10 A recent pilot
study11 suggests that simultaneous start of CSII and CGM is
associated with better adherence to sensor use compared with
delayed CGM training. Nevertheless, when 24 Danish adult
patients who participated to an European SAP trial were
followed up for 36 months after the trial, 16 of the 24 were
still using SAP at the end of the extension period, including
14 patients who used it more than 70% of the time with a
similar sustained decrease in HbA1c level, regardless of
whether SAP was started during or after the RCT.12
In the pediatric population, the percentage of patients still
using SAP at M6 (51.9%) was much lower than during the
JDRF RCT (95% at M6)13 but comparable to the 52.4% of the
children still using SAP 1 year after the interventional Pe-
diatric ONSET Study.14 However, even if in the JDRF study
most patients were still using CGM, the wear of sensor was
less than optimal (6 days per week or more) at M6 for more
than half of the children 814 years of age and for 71% of the
1524 year olds.15 Furthermore, the design of the study was
very different: in order to be included in the JDRF study,
patients had to show the ability to wear a sensor and to insert a
new sensor at home.16 It should also be noted that the defini-
tion of the sensor wear differs greatly among studies. In our
study we chose to precisely calculate the ratio of the minutes of
sensor wear to the total time of the study in minutes, reflecting
the real duration of sensor wear throughout the study. The
difficulties of sensor wear and thus the relative lack of efficacy
of CGM in the youngest patients have been described in other
studies as well.17 Furthermore, it should be noted that in our
study, almost all children who withdrew from CGM also did it
with CSII. It has been reported that in children, SAP therapy is
considered first for its convenience rather than its efficacy.18
The size of our pediatric population was too small to draw any
conclusion, but more favorable outcomes of SAP have been
previously reported in children compared with adolescents.19
Thus, it appears that in France the involvement of multiple
PICARD ET AL.
health professionals in SAP training and follow-up helped
increasing the participants adherence to sensor wear.
HbA1c reduction after switching from MDI to SAP was
much less in the present real-life study (0.48%) than the 0.8%
decrease in the STAR3 RCT20 or the 1.2% reduction in the
EURYTHMICS Trial21 but was comparable to the -0.50%
change in the EVADIAC Sensor Study, although in this study
patients were treated either by MDI or by CSII.22 Other RCTs
reported even much lower HbA1c reductions such as -0.27%
with CGM23 or even no decrease compared with the control
group in one of the first CGM studies.24
One of the goals of CGM use is to decrease the incidence of
hypoglycemia, especially severe hypoglycemia and nocturnal
hypoglycemia. In our study, the proportion of patients with at
least one severe hypoglycemia episode decreased from 20.7%
in the 6 months prior to the study to 13.6% (M0M3) and 13.3
(M3M6). Such a decrease may be compared with the one in
the JDRF study where the proportion of subjects with at least
one severe hypoglycemia episode decreased from 12% in the
6-month control period to 10% in the 6-month CGM use pe-
riod in adult patients (25 years old).25 The design of our study
did not specifically identify nocturnal hypoglycemia.
The high degree of satisfaction in the present study is in
accordance with that observed in large randomized studies.26
As expected, the lowest satisfaction scores were obtained for
alarms a few days after starting CGM but improved with
time. A recent survey on 877 online questionnaires in CGM
users has shown that the best predictors of a good quality of
life in RCTs are the satisfaction with the device accuracy, its
convenience, and self-confidence to use CGM data.27
One of the limiting factors of CGM device is their cost,28
which may be reduced by extending sensor use beyond the
manufacturer-specified lifetime.29 CGM reimbursement is an
issue all over Europe,30 although it has already been ap-
proved in more than 10 countries. RCTs showing SAP effi-
cacy and safety but also real-life studies of CGM in clinical
practice could help focusing the indications and implement-
ing CGM and SAP in hospital-based or office-based practice.
Conclusions
The present real-life study has demonstrated that sy-
nergisticc SAP training by different health professionals,
including HCPNs in France, is associated with good com-
pliance to sensor wear, improved metabolic control (HbA1c
variation), and reduction in severe hypoglycemia incidence.
Thus, it confirms data from previous observational or ran-
domized trials. Furthermore, high satisfaction scores were
observed. SAP training in dedicated diabetes centers and
subsequent home follow-up by HCPNs have certainly helped
with the good sensor adherence. We conclude that the use of
SAP in selected patients with T1D in our conditions is real-
istic, effective, and safe in real-life practice.
Acknowledgments
This study was sponsored by and funded by VitalAire and
Medtronic. Statistical analyses were performed by RCTs. All
the HCPNs were employed by VitalAire. Editorial support was
provided by S.P. Funding for this assistance was provided by
VitalAire. The authors are very grateful to the patients and
the patients families for their committed participation in the
study.
 ADHERENCE TO SAP THERAPY IN TYPE 1 DIABETES
Author Disclosure Statement
S.P. reports personal fees from VitalAire during the conduct
of the study, as well as personal fees from Sanofi, Novo Nordisk,
Animas, Lifescan, VitalAire, and Janssen outside the submitted
work. H.H. reports grants from Medtronic, personal fees from
Abbott, grants from Novo Nordisk, personal fees from Lilly,
grants and personal fees from Sanofi, and grants from Lifescan
outside the submitted work. S.B.-R. reports other support from
VitalAire during the conduct of the study, as well as personal
fees from Sanofi and NovoNordisk outside the submitted work.
E.G.-B. reports personal fees from Sanofi, Lilly, Medtronic,
Orkyn, VitalAire, and Assdia outside the submitted work. D.N.
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.
declares fees and payment from VitalAire for statistical data
analyses of the manuscript. Y.R. declares no conflict of interest.
B.G. reports grants from Medtronic, VitalAire, Sanofi, and
Novo Nordisk and personal fees from Medtronic, Abbott,
VitalAire, Orkyn, Sanofi, Astra Zeneca, Lilly, MSD, Novo
Nordisk, GSK, and Novartis outside the submitted work.
References
1. Raccah D, Sulmont V, Reznik Y, et al.: Incremental value
of continuous glucose monitoring when starting pump
therapy in patients with poorly controlled type 1 diabetes:
the RealTrend study. Diabetes Care 2009;32:22452250.
2. Sulmont V, Lassmann-Vague V, Guerci B, et al.: Access of
children and adolescents with type 1 diabetes to insulin
pump therapy has greatly increased in France since 2001.
Diabetes Metab 2011;37:5963.
3. Lassmann-Vague V, Clavel S, Guerci B, et al.: When to treat
a diabetic patient using an external insulin pump. Expert
consensus. Societe francophone du diabete (ex ALFEDIAM)
2009. Diabetes Metab 2010;36:7985.
4. Benhamou PY, Catargi B, Delenne B, et al.: Real-time
continuous glucose monitoring (CGM) integrated into the
treatment of type 1 diabetes: consensus of experts from SFD,
EVADIAC and SFE. Diabetes Metab. 2012;38(Suppl 4):
S67S83.
5. Diabetes Control and Complications Trial Research Group:
Hypoglycemia in the Diabetes Control and Complications
Trial. Diabetes 1997;46:271286.
6. Tansey M, Laffel L, Cheng J, et al.: Satisfaction with
continuous glucose monitoring in adults and youths with
Type 1 diabetes. Diabet Med 2011;28:11181122.
7. Hirsch IB: Clinical review: Realistic expectations and
practical use of continuous glucose monitoring for the en-
docrinologist. J Clin Endocrinol Metab 2009;94:22322238.
8. Nrgaard K, Scaramuzza A, Bratina N, et al.: Routine
sensor-augmented pump therapy in type 1 diabetes: the IN-
TERPRET study. Diabetes Technol Ther 2013;15:273280.
9. Bergenstal RM, Tamborlane WV, Ahmann A, et al.: Sensor-
augmented pump therapy for A1C reduction (STAR 3)
study: results from the 6-month continuation phase. Diabetes
Care 2011;34:24032405.
10. Moreno-Fernandez J, Gomez FJ, Gazquez M, et al.: Real-
time continuous glucose monitoring or continuous subcu-
taneous insulin infusion, what goes first?: results of a pilot
study. Diabetes Technol Ther 2013;15:596600.
11. Olivier P, Lawson ML, Huot C, et al.: Lessons learned from
a pilot RCT of simultaneous versus delayed initiation of
continuous glucose monitoring in children and adolescents
with type 1 diabetes starting insulin pump therapy. J Dia-
betes Sci Technol 2014;8:523528.
133
12. Schmidt S, Nrgaard K: Sensor-augmented pump therapy
at 36 months. Diabetes Technol Ther 2012;14:11741177.
13. Chase HP, Beck RW, Xing D, et al.: Continuous glucose
monitoring in youth with type 1 diabetes: 12-month follow-
up of the Juvenile Diabetes Research Foundation continu-
ous glucose monitoring randomized trial. Diabetes Technol
Ther 2010;12:507515.
14. Kordonouri O, Hartmann R, Pankowska E, et al.: Sensor
augmented pump therapy from onset of type 1 diabetes: late
follow-up results of the Pediatric Onset Study. Pediatr
Diabetes 2012;13:515518.
15. Juvenile Diabetes Research Foundation Continuous Glu-
cose Monitoring Study Group, Beck RW, Buckingham B,
et al.: Factors predictive of use and of benefit from con-
tinuous glucose monitoring in type 1 diabetes. Diabetes
Care 2009;32:19471953.
16. Juvenile Diabetes Research Foundation Continuous Glucose
Monitoring Study Group, Tamborlane WV, Beck RW, et al.:
Continuous glucose monitoring and intensive treatment of
type 1 diabetes. N Engl J Med 2008;359:14641476.
17. Mauras N, Beck R, Xing D, et al.: A randomized clinical trial to
assess the efficacy and safety of real-time continuous glucose
monitoring in the management of type 1 diabetes in young
children aged 4 to <10 years. Diabetes Care 2012;35:204210.
18. Peyrot M, Rubin RR; STAR 3 Study Group: Treatment
satisfaction in the sensor-augmented pump therapy for A1C
reduction 3 (STAR 3) trial. Diabet Med 2013;30:464467.
19. Slover RH, Welsh JB, Criego A, et al.: Effectiveness of
sensor-augmented pump therapy in children and adoles-
cents with type 1 diabetes in the STAR 3 study. Pediatr
Diabetes 2012;13:611.
20. Bergenstal RM, Tamborlane WV, Ahmann A, et al.: Ef-
fectiveness of sensor-augmented insulin-pump therapy in
type 1 diabetes. N Engl J Med 2010;363:311320.
21. Hermanides J, Nrgaard K, Bruttomesso D, et al.: Sensor-
augmented pump therapy lowers HbA1c in suboptimally
controlled Type 1 diabetes; a randomized controlled trial.
Diabet Med 2011;28:11581167.
22. Riveline JP, Schaepelynck P, Chaillous L, et al.: Assess-
ment of patient-led or physician-driven continuous glucose
monitoring in patients with poorly controlled type 1 dia-
betes using basal-bolus insulin regimens: a 1-year multi-
center study. Diabetes Care 2012;35:965971.
23. Battelino T, Phillip M, Bratina N, et al.: Effect of contin-
uous glucose monitoring on hypoglycemia in type 1 dia-
betes. Diabetes Care 2011;34:795800.
24. Hirsch IB, Abelseth J, Bode BW, et al.: Sensor-augmented
insulin pump therapy: results of the first randomized treat-
to-target study. Diabetes Technol Ther 2008;10:377383.
25. Juvenile Diabetes Research Foundation Continuous Glucose
Monitoring Study Group: Effectiveness of continuous glucose
monitoring in a clinical care environment: evidence from the
Juvenile Diabetes Research Foundation continuous glucose
monitoring ( JDRF-CGM) trial. Diabetes Care 2010;33:1722.
26. Juvenile Diabetes Research Foundation Continuous Glu-
cose Monitoring Study Group, Beck RW, Lawrence JM,
et al.: Quality-of-life measures in children and adults with
type 1 diabetes: Juvenile Diabetes Research Foundation
Continuous Glucose Monitoring randomized trial. Diabetes
Care 2010;33:21752177.
27. Polonsky WH, Hessler D: What are the quality of life-related
benefits and losses associated with real-time continuous
glucose monitoring? A survey of current users. Diabetes
Technol Ther 2013;15:295301.
 134
28. McQueen RB, Ellis SL, Maahs DM, et al.: Frequency of
continuous glucose monitoring use and change in hemo-
globin A1C for adults with type 1 diabetes in a clinical
practice setting. Endocr Pract 2014;20:10071015.
29. Luijf YM, Mader JK, Doll W, et al.: Accuracy and reliability
of continuous glucose monitoring systems: a head-to-head
comparison. Diabetes Technol Ther 2013;15:722727.
30. Heinemann L, Franc S, Phillip M, et al.: Reimbursement for
continuous glucose monitoring: a European view. J Diabetes
Sci Technol 2012;6:14981502.
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.
Appendix 1
The SENLOCOR Study Group
Investigators are listed as co-investigators, with the center
and the town indicated:
Gwenaelle Arnault Ouary, Centre Hospitalier Bretagne
Atlantique, Vannes; Sabine Baillot-Rudoni, Hopital Du
Bocage, Centre Hospitalier Universitaire Dijon, Dijon; Pas-
cal Barat, Centre Hospitalier Pellegrin, Bordeaux; Marie-
Gaelle Barrande, Hopital De La Source, Orleans; Noura
Belahbib-Messaouidi, Centre Hospitalier Dreux Hopital
Victor Jousselin, Dreux; Pierre-Yves Benhamou, Hopital
Nord CHU 38, Grenoble; Candace Bens Ignor, Hopital Du
Bocage, Centre Hospitalier Universitaire Dijon, Dijon;
Bouchra Betari-Tabet, Cabinet, Sainte Genevieve des Bois;
Patricia Blanchard, Centre Hospitalier De Cornouailles,
Quimper; Elisabeth Bonnemaison, Hopital Gatien De Cloche-
ville, Tours; Nathalie Bourcigaux, Hopital Saint Antoine,
Paris; Juliette Cahen-Varsaux, Hopital dArgenteuil, Argen-
teuil; Bogdan Catargi, Hopital Haut Leveque, Pessac; Lucy
Chaillous, CHU de Nantes Hotel Dieu, Nantes; Nicolas
Chevalier, Hopital de LArchet Adulte, Nice; Sylvaine Cla-
vel, Hopital Hotel Dieu, Le Creusot; Christine Coffin-
Boutreux, Centre Hospitalier Perigueux, Perigueux; Bernard
Colle, Hopital Desgenettes, Lyon; Carole Collet-Gaudillat,
Andre Mignot, CH de Versailles, Le Chesnay; Michele
Couturier, Centre Hospitalier De Belfort, Belfort; Fabienne
Dalla-Vale, Hopital Arnaud De Villeneuve, Montpellier;
Thanh lan Dang Duy, CH Sud Francilien,Corbeil Essonnes;
Francois Dorey, Centre Hospitalier De Valenciennes, Va-
lenciennes; Eric Dresco, Hopital De Dourdan, Dourdan; Se-
verine Dubois, CHU dAngers, Angers; Cedric Fagour,
Hopital Haut Leveque, Pessac; Salha Fendri, Hopital Sud,
CHU Amiens, Amiens; Catherine Fermon, Centre Hospita-
lier De Roubaix, Roubaix; Laurence Floch, CHU de Nantes
Hotel Dieu, Nantes; Thierry Gabreau, Centre Hospitalier
dAuxerre, Auxerre; Sophie Galinat, Hopital du Cluzeau,
Limoges; Jean-Francois Gautier, Hopital Saint Louis, Paris;
Nathalie Gervaise, Clinique Saint Gatien, Tours; Didier
Gouet, Centre Hospitalier La Rochelle, La Rochelle; Bruno
Guerci, CHU Brabois, Vandoeuvre Les Nancy; Patrick
Hassler, Centre Hospitalier dHaguenau, Haguenau; Jean-
Pierre Haulot, Centre Hospitalier De Tulle, Tulle; Blandine
Janand-Delenne, Centre Hospitalier Du Pays DAix, Aix en
Provence; Mickael Joubert, CHU Cote De Nacre, Caen;
Valerie Jullien, Hopital Rene Dubos, Pontoise; Miriam Lad-
sous, Centre Hospitalier De Valenciennes, Valenciennes;
Tessa Lambolez, Hopital De Longjumeau, Longjumeau;
PICARD ET AL.
Address correspondence to:
Bruno Guerci, MD, PhD
University of Lorraine
Diabetology, Metabolic Diseases & Nutrition
Brabois Hospital
CHU of Nancy
CIC INSERM, ILCV
54500 Vandoeuvre Les Nancy, France
E-mail: b.guerci@chu-nancy.fr
Anne-Marie Le Roux, Clinique Princess, Pau; Anne-Marie
Leguerrier, CHRU De Rennes Hopital Sud, Rennes; Marie
Lejeune, Centre Hospitalier De Bligny, Briis Sous Forges;
Marc Lepeut, Centre Hospitalier De Roubaix, Roubaix; Syl-
vie Loison, Hopital Robert Debre, Paris; Ignacio Lopez,
Centre Hospitalier Du Vexin, Magny en Vexin; Celine Lukas-
Croisier, Hopital Robert Debre, CHU Reims, Reims; David
Malet, Hopital De Lourdes, Lourdes; Richard Marechaud,
CHU Poitiers La Miletrie, Poitiers; Laurent Meyer, Cabinet
Medical Endocrinologie, Strasbourg; Kamel Mohammedi,
Hopital Bichat-Claude Bernard, Paris; Benedicte Mycinski,
Centre Hospitalier de Calais, Calais; Sophie Nadler, Hopital
Saint Joseph, Paris; Anne Navaranne-Roumec, Hopital Haut
Leveque, Pessac; Eric Renard, Hopital Lapeyronie CHU
Montpellier, Montpellier; Jean-Jacques Robert, Hopital
Necker Enfants Malades, Paris; Martine Roques, Centre
Hospitalier Perigueux, Perigueux; Veronica Roudaut, Hopital
De Fontainebleau, Fontainebleau; Pauline Schaepelynck-
Belicar, Hopital La Conception, Marseille; Pierre Serusclat,
Ghm Les Portes Du Sud, Venissieux; Agnes Sola-Gazagnes,
Hopital Cochin, Paris; Emmanuel Sonnet, CHRU Brest Site
Hopital de la Cavale Blanche, Brest; Anne Spiteri, Hopital
Nord CHU 38, Grenoble; Veronique Sulmont, Centre Hos-
pitalier Alpes LemanContamine sur Arve; Frederique Tixier,
Hopital Femme Mere Enfant, Bron; Odile Verier Mine,
Centre Hospitalier De Valenciennes, Valenciennes; Sylvie
Villar-Fimbel, HCL Groupement Hospitalier Est, Bron; and
Christel Voinot, Centre Hospitalier De Pau, Pau.
Appendix 2
Educational material to be used by the nurses
employed by the homecare provider at the inclusion
and follow-up visits
HCPNs contribute to the education of the patient on how to
properly insert the sensor and how calibrate it, as well as to
anticipate the supply of sensors.
At M0, the patient is supposed to:
 Know how to insert and calibrate the sensor
 Be familiar with the main menu of the sensor use
 Know the differences between interstitial and capillary
blood glucose
 Know how to read and to understand the CGM graphs
on the pump screen
 ADHERENCE TO SAP THERAPY IN TYPE 1 DIABETES
 Turn on/off the alarms (zero alarm; glucose alarm: NO)
 Set the glucose range target
At M0 + 6 days at home (first sensor replacement), the
HCPN will:
 Assess the ability of the patient to insert the sensor
 Teach the patient how to recalibrate the sensor
 Set and use the alarms with the patient (use the range
of goals sheet that has been filled with the physician)
 Proceed to the data extraction (from the pump and the
blood glucose meter)
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.
135
At M0 + 6 days, the patient is supposed to:
 Know his or her range of goals for his or her blood glucose
 The repetition time for the alarm (glucose alerts)
 Be familiar with the predictive alerts
 Be familiar with the speed alerts
The HCPNs visited the patients at home at Day 6, Day 12
(if needed), and M1 and saw him or her right before the M3
and M6 medical visits to record the observance and remind
the patients to fill the questionnaire
M2 contact was either a phone call or a visit.
 This article has been cited by:

1. Christopher G. Parkin, Claudia Graham, John Smolskis. 2017. Continuous Glucose Monitoring Use in Type 1 Diabetes:
Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization. Journal
of Diabetes Science and Technology 11:3, 522-528. [Crossref]
2. L. Schoumacker-Ley, L. Duchesne, T. Cuny, P. Bhme, S. Benzirar, R. Fay, O. Ziegler, B. Guerci. 2017. Optimisation du contrle
glycmique chez les patients diabtiques de type 1 par Mesure Continue du Glucose (MCG) et arrt prdictif de la pompe :
rsultats de ltude OMEGA. Mdecine des Maladies Mtaboliques 11:2, 137-147. [Crossref]
3. Andrea E Scaramuzza, Claudia Arnaldi, Valentino Cherubini, Elvira Piccinno, Ivana Rabbone, Sonia Toni, Stefano Tumini,
Gilberto Candela, Paola Cipriano, Lucia Ferrito, Lorenzo Lenzi, Davide Tinti, Ohad Cohen, Fortunato Lombardo. 2017.
Recommendations for the use of sensor-augmented pumps with predictive low-glucose suspend features in children: The
Downloaded by University Of Warwick from online.liebertpub.com at 09/07/17. For personal use only.

importance of education. Pediatric Diabetes . [Crossref]

4. Anhalt Henry. 2016. Limitations of Continuous Glucose Monitor Usage. Diabetes Technology & Therapeutics 18:3, 115-117.
[Abstract] [Full Text HTML] [Full Text PDF] [Full Text PDF with Links]