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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessement of the Influence of Continuous Glucose Measurement on Glucose Control of Type 1 Diabetic Patients Treated by Implanted Insulin Pump

Conditions
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Type1diabetes

Intervention / Treatment
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* Device: Continuous Glucose Measurement (CGM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Measurement (CGM)<br>Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II). | Device: Continuous Glucose Measurement (CGM)<br>* Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).<br>|
| No Intervention: Control<br>Patients will manage their diabetes as usual as recommended by their care team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent with glucose | Time spent with glucose between 70-180mg/dL | last 20 days of intervention period | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TIDM, Type1diabetes, Implantable Pump, CGM