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Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease
The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD). The main objective is: • To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal disease Secondary objectives are: • To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this population Participants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks. Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels.
Details
| Lead sponsor | Steno Diabetes Center Copenhagen |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 15 |
| Start date | Thu Apr 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Jul 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Dialysis
- Chronic Kidney Disease
- Diabetes Mellitus, Type 2
- Diabetes Mellitus, Type 1
- Hemodialysis
- Peritoneal Dialysis
Interventions
- 2nd Generation Automated Insulin Delivery (AID) system
Countries
Denmark