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Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.
Patients with type 1 diabetes and obesity are at risk of "double diabetes". Bariatric surgery may be indicated for these patients, to combat insulin resistance. Nevertheless, post-operative patients are at risk of hypoglycemia.
At the same time, patients with type 1 diabetes can benefit from a hybrid closed loop insulin pump to improve diabetes control and reduce the occurrence of hypoglycemia.
In type 1 diabetic patients who have undergone bariatric surgery and are treated with a hybrid closed loop insulin pump, continuous glucose measurement can be studied. In the medium and long term, the efficacy and safety of this system in this context will be described.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bariatric surgery | Other | Having undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| time spent within glycemic target 70-180 mg/dL | time spent within glycemic target 70-180 mg/dL in type 1 diabetes patients who underwent bariatric surgery, | at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time spent in level 1 hyperglycemia (181-250 mg/dL) | Time spent in level 1 hyperglycemia (181-250 mg/dL) Time spent in level 1 hyperglycemia (181-250 mg/dL) Time spent in level 1 hyperglycemia (181-250 mg/dL) | at 3 months |
| Time spent in level 2 hyperglycemia (>250 mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
- Patient informed and opposed to data use
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Patient with type 1 diabetes who underwent bariatric surgery and treated by hybrid closed-loop insulin pump.
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey BOULATE, MD | Centre Hospitalier Sud Francilien | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | 91106 | France | ||
| CHU de Nantes |
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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 |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Time spent in level 2 hyperglycemia (>250 mg/dL) |
| at 3 months |
| HbA1c | HbA1c | at 3 months |
| Coefficient of variation | Coefficient of variation | at 3 months |
| Time spent in level 1 hypoglycemia (51-70 mg/dl) | Time spent in level 1 hypoglycemia (51-70 mg/dl) | at 3 months |
| Time spent in level 2 hypoglycemia (< 50 mg/gdl) | Time spent in level 2 hypoglycemia (< 50 mg/gdl) | at 3 months |
| Nantes |
| France |
| 44000 |
| France |
| APHP Hôpital de la Pitié Salpètrière | Paris | France | 75013 | France |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |