Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease (NCT06330194) | Clinical Trial Compass
CompletedNot Applicable
Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease
Denmark15 participantsStarted 2024-04-18
Plain-language summary
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:
ā¢ 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:
ā¢ 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Written informed consent obtained before any trial-related procedures are performed
ā. Type 1 diabetes of at least 1-year duration or insulin requiring type 2 diabetes (Total insulin dose should be below 200 IE per day)
ā. Maintenance HD, PD, or CKD stage 3b-5 (not on dialysis).
ā. Subject must be willing and able to comply with trial protocol
ā. HbA1c \<91 mmol/mol (10.5%)
Exclusion criteria
ā. History of ketoacidosis within the past 6 months
ā. Moderate to severe cognitive impairment
ā. Major allergy to tape/ adhesives
ā. Women who are pregnant or planning pregnancy
ā. Life-expectancy to \<6 months
ā
What they're measuring
1
Percent time in sensor glucose target range (3.9-10.0 mmol/L)
Timeframe: End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22
ā. Treatment with sulphonylureas in pre-dialysis participants (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines)
ā. Treatment with non-insulin glucose lowering therapies may not be used on dialysis participants (with the exception of GLP1 agonists used in preparation for transplantation)