Bariatric Surgery, Type 1 Diabetes
Conditions
Keywords
Bariatric surgery, type 1 diabetes, hybrid closed-loop insulin pump
Brief summary
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.
Detailed description
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.
Interventions
OTHERbariatric surgery
Having undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery
Sponsors
Centre Hospitalier Sud Francilien
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Major patient * With type 1 diabetes for \> 1 year * Obese (BMI≥30) * Having undergone bariatric surgery * On a hybrid closed-loop insulin pump * Not pregnant * No hybrid closed-loop insulin pump discontinuation for more than 45 days after surgery
Exclusion criteria
\- Patient informed and opposed to data use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time spent within glycemic target 70-180 mg/dL | at 3 months | time spent within glycemic target 70-180 mg/dL in type 1 diabetes patients who underwent bariatric surgery, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in level 2 hyperglycemia (>250 mg/dL) | at 3 months | Time spent in level 2 hyperglycemia (\>250 mg/dL) |
| HbA1c | at 3 months | HbA1c |
| Time spent in level 1 hyperglycemia (181-250 mg/dL) | at 3 months | 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 hypoglycemia (51-70 mg/dl) | at 3 months | Time spent in level 1 hypoglycemia (51-70 mg/dl) |
| Time spent in level 2 hypoglycemia (< 50 mg/gdl) | at 3 months | Time spent in level 2 hypoglycemia (\< 50 mg/gdl) |
| Coefficient of variation | at 3 months | Coefficient of variation |
Countries
France
Outcome results
None listed