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The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.
The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.
Grenoble and Toulouse will test the prandial algorithm with several carbohydrate intake and a primer of 50% or 75% of the total bolus. Groups of patients are described as follows:
CHSF (Centre Hospitalier Sud Francilien) will test the algorithm glycemic control during physical activity of moderate (50% VO2max) or high intensity (75% VO2max) for 30 minutes on a bicycle ergometer. In different situations, three patient groups will be created:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proposed treatment by Diabeloop algorithm | Experimental | the insulin dose is calculated by the algorithm based on the usual treatment of the patient, the ratio I / C, the intensity of physical activity and blood glucose sensor. |
|
| usual treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | the intervention is applied only at the dose of insulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in glucose reference intervals | After the end of the tests |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia) | To evaluate the efficacy and safety of prandial algorithm, informed carbohydrate intake by the patient either quantitatively or semi-quantitative, or not informed way. | After the end of the tests |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC in conditions identical meals for each trigger level (50 or 75%). Measuring AUC during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night. |
|
Inclusion Criteria:
For Grenoble and Toulouse Centers (Prandial algorithm test : MEAL):
For CHSF center (test of algorithm during activity):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia FRANC, MD | Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète | Principal Investigator |
| Pierre-Yves BENHAMOU, Pr. | CHU of Grenoble | Principal Investigator |
| Guillaume CHARPENTIER, MD | Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Évry | 91058 | France | |||
| University Hospital of Grenoble |
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| After the end of the tests |
| Grenoble |
| 38043 |
| France |
| University Hospital of Toulouse | Toulouse | 31403 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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