Clinical trial NCT03048227: Can Continuous Glucose Measurements Help Diabetic Patients Treated With an Implantated Pump?
Official title: Assessement of the Influence of Continuous Glucose Measurement on Glucose Control of Type 1 Diabetic Patients Treated by Implanted Insulin Pump
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type1diabetes
Keywords: TIDM
Type1diabetes
Implantable Pump
CGM
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: During this study, we propose to assess the utility of Continuous Glucose Measurements (CGM) in a group of Type 1 diabetic patients treated with an implanted insulin pump. Patients will participate in two period of 3 months separated by a 3 months washout. During one period, they will use CGM to adapt their insulin therapy while during the other period, they will manage their diabetes with their usual capillary blood glucose meter. We except to observe an increase of time spent in glucose safe range when using CGM.

Detailed description: Glucose control and quality of life of patients with type 1 diabetes with high glucose variability can be improve with use of an implanted pump which delivers insulin by the intra-peritoneal route. Some patients however still have difficulties to achieve their glycemic goal despite this therapy. Continuous Glucose Measurements (CGM) has proven to be able to improve glucose control (HbA1c, time spent in hypoglycaemia) of patients treated with an external insulin pump. No trial has been performed yet to assess the utility of CGM on patients using an intra-peritoneal insulin delivery.

During this study, we propose to assess the influence of CGM use on type 1 diabetic subject treated with implanted insulin pump. It is a prospective, randomized cross-over study. After a 2 weeks run-in period with CGM followed by a 4 weeks break, subjects will participate at two experimental periods of 3 months separated with a 3 month washout. During the intervention phase, patient will use a CGM system (Abbott Freestyle Navigator II) to adapt their insulinotherapy. During the control period, patients will based their insulinotherapy upon their usual care and capillary glucose measurements. The order of the periods will be randomized.

The main endpoint will be the time spent in glucose interval 70-180mg/dL during the last 20 days of each period. The control arm will wear a blinded sensor during this phase to allow comparison.

Eligibility criteria: Inclusion Criteria:

* Age from 18 and 70
* Type 1 diabetes for at least 1 year
* Treatment of diabetes withimplanted insulin pump for at least 6 months
* HbA1c level between 7.5 and 10%
* Minimum of 4 capillary glucose controls per day over past 3 months
* Use of CGM at least 75% during run-in period
* Willingness to follow all study procedures
* Informed consent signed
* Patient must be affiliated or beneficiary of a social medical insurance

Exclusion Criteria:

* Pregnancy of breast feeding, or intention to be pregnant during the study duration
* Impaired cognitive or psychological abilities which may result in defective adherence to study procedures
* Any disease which could make the use glucose sensor difficult (ex : blindness, severe arthrosis or immobility)
* Known allergy to medical adhesive or glucose sensor component
* Medication affecting glucose metabolism, unless stable during the study
* Long term use of continuous glucose measurements during pas 6 months
* Pump implanted more than 6 years ago
* Anti-insulin antobodies syndrom
* Active enrollment in another clinical trial or participation in a study within 30 days

Primary outcomes:
measure: Time spent with glucose
timeFrame: last 20 days of intervention period
Secondary outcomes:
measure: HbA1c
timeFrame: last 20 days of intervention period
measure: Time spent in hypoglycaemia
timeFrame: last 20 days of intervention period
measure: Time spent in hyperglycemia
timeFrame: last 20 days of intervention period
measure: Time spent in glucose range
timeFrame: last 20 days of intervention period
measure: Glucose mean and standard deviation
timeFrame: last 20 days of intervention period
measure: Low Blood Glucose Index (LBGI)
timeFrame: last 20 days of intervention period
measure: High Blood Glucose Index (HBGI)
timeFrame: last 20 days of intervention period
measure: Glucose Variability
timeFrame: last 20 days of intervention period
measure: Glucose Variability
timeFrame: last 20 days of intervention period
measure: Glucose Variability
timeFrame: last 20 days of intervention period
measure: Number of symptomatique hypoglycaemia, severe et non severe
timeFrame: last 20 days of intervention period
measure: Number of pump programmation
timeFrame: last 20 days of intervention period
measure: Percentage of sensor use
timeFrame: last 20 days of intervention period
measure: Score of Quality of Life questionnaire (IDSRQ)
timeFrame: last 20 days of intervention period
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chu de Nancy
state: Vandoeuvre-les-nancy
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Corbeil-essonnes
country: France
facility: CH Sud Francilien
city: Dijon
country: France
facility: CHU de Dijon
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: AP - Hôpitaux de Marseille
city: Montpellier
country: France
facility: UHMontpellier
city: Paris
country: France
facility: AP - Hôpitaux de Paris
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: Chu de Toulouse
Study officials:
affiliation: University Hospital, Montpellier
name: Eric RENARD, MD
role: PRINCIPAL_INVESTIGATOR
References: