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To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy:
Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.
The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unsual treatment | No Intervention | The patient will have his usual treatment in this arm | |
| The Diabeloop algorithm | Experimental | In this arm, the insulin Asp(B28) 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin, Asp(B28)- | Drug | the insulin dose is calculated by the "Diabeloop" algorithm and then administered to the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in blood glucose range [70-180 mg/dl] | comparing the time spent in [70-180 mg/dl] with usual algorithm vs Diabeloop algorithm. | up to 24 hours after each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent Blood Glucose range [80-140 mg/dl] | Comparing the time spent in range [80-140 mg/dl] with usual algorithm vs Diabeloop algorithm | 24 hours after each treatment period |
| time spent below 70 mg/dl and above 180 mg/dl |
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Inclusion Criteria:
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 |
| Ahmed DAOUDI, 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 |
| Sandrine LABLANCHE, MD | CHU of Grenoble | Principal Investigator |
| Eric RENARD, Pr | CHU of Montpellier | Principal Investigator |
| Anne FARRET, MD | CHU of Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier du Sud Francillien | Évry | 91058 | France | |||
| University Hospital of Grenoble |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| up to 24 hours after each treatment period |
| Grenoble |
| 38043 |
| France |
| University Hospital of Montpellier | Montpellier | 34295 | France |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |