Can Continuous Glucose Measurements Help Diabetic Patients Treated With an Implantated Pump?

Not Applicable

Terminated

• Conditions: Type1diabetes
• Interventions: Device: Continuous Glucose Measurement (CGM)

• Registration Number: NCT03048227
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-04-21
• Primary Completion: 2020-03-21
• Study Completion: 2020-03-21
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Measurement (CGM)	Continuous Glucose Measurement (CGM)	Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).

Primary Outcome Measures

Name	Time	Method
Time spent with glucose	last 20 days of intervention period	Time spent with glucose between 70-180mg/dL

Secondary Outcome Measures

Name	Time	Method
Time spent in hypoglycaemia	last 20 days of intervention period	Time spent in hypoglycaemia (\<70mg/dL)
HbA1c	last 20 days of intervention period	HbA1c
Time spent in hyperglycemia	last 20 days of intervention period	Time spent in hyperglycemia (\>180mg/dL)
Time spent in glucose range	last 20 days of intervention period	Time spent in glucose range \[70-180\] and \[80-140\] mg/dL
High Blood Glucose Index (HBGI)	last 20 days of intervention period	High Blood Glucose Index (HBGI)
Glucose mean and standard deviation	last 20 days of intervention period	Glucose mean and standard deviation
Low Blood Glucose Index (LBGI)	last 20 days of intervention period	Low Blood Glucose Index (LBGI)
Percentage of sensor use	last 20 days of intervention period	Percentage of sensor use
Number of symptomatique hypoglycaemia, severe et non severe	last 20 days of intervention period	Number of symptomatique hypoglycaemia, severe et non severe
Score of Quality of Life questionnaire (IDSRQ)	last 20 days of intervention period	Score of Quality of Life questionnaire (IDSRQ)
Glucose Variability	last 20 days of intervention period	Glucose Variability: MODD : Mean Of daily blood Glucose Difference
Number of pump programmation	last 20 days of intervention period	Number of pump programmation

Trial Locations

Locations (10)

Chu de Nancy; 🇫🇷 Nancy, Vandoeuvre-les-nancy, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHRU de Lille; 🇫🇷 Lille, France

UHMontpellier; 🇫🇷 Montpellier, France

AP - Hôpitaux de Paris; 🇫🇷 Paris, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

AP - Hôpitaux de Marseille; 🇫🇷 Marseille, France

CH Sud Francilien; 🇫🇷 Corbeil-essonnes, France

Chu de Toulouse; 🇫🇷 Toulouse, France