Evaluation of the Function Stop Before Hypoglycemia on External Insulin Pump

Study Overview
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Brief Summary
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This study compares the apparition of hypoglycaemia in type I diabetic patients between 2 phases: the one without the use of SmartGuard® function and the one with the use of SmartGuard® function.

Detailed Description
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The aim of this study is to compare SmartGuard® function with captor and insulin pump to improve the glycemia stability in real condition. There are several phases: phase 1: insulin pump without captor (12 weeks) phase 2: insulin pump with captor and without SmartGuard® function (4X6 days; 4 weeks) phase 3: insulin pump with captor and with SmartGuard® function (6X6 days; 6 weeks) phase 4: insulin pump without captor (4 weeks)

Official Title
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Evaluation of the Function Stop Before Hypoglycemia on External Insulin Pump Coupled With the Continuous Measurement of Interstitial Glycemia in Type 1 Diabetic Adults

Conditions
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Type I Diabetes

Intervention / Treatment
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* Device: MiniMed™ 640G
* Device: Captor CGM Enlite®
* Device: SmartGuard®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type I diabetic patients undr basal/prandial diet treated by insuline with no insuline pump during at least 3 months with HbA1C dosed during the 3 months before inclusion Exclusion Criteria: minor patients pregnant woman already participating to another studies

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MiniMed™ 640G alone<br>MiniMed™ 640G (insulin pump) is used without Captor CGM Enlite® (captor) at phase 1 and phase 4 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. | Device: MiniMed™ 640G<br>* The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin<br>|
| Other: MiniMed™ 640G + Captor CGM Enlite®<br>insulin pump coupled with captor without SmartGuard® function tat phase 2 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. | Device: MiniMed™ 640G<br>* The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin<br>Device: Captor CGM Enlite®<br>* The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level<br>|
| Other: MiniMed™ 640G + Captor + SmartGuard®<br>insulin pump + captor + SmartGuard® function are used at phase 3 of the study. ADDQoL, BIPQ and HADS questionnaire are performed. | Device: MiniMed™ 640G<br>* The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin<br>Device: Captor CGM Enlite®<br>* The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level<br>Device: SmartGuard®<br>* This SmartGuard® function is used to improve the glycemia stability in real condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hypoglycemia between a phase with no SmartGuard® function and a phase with SmartGuard® function | The primary outcome is the area between the glycemic curve and the hypoglycemic level (70 mg/dL), measured between the 6 last days of the phase without SmartGuard® function and the 6 last days with the use of SmartGuard® function | 6 days |