NCT06330194Completed
Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease
Glucose Control With a Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 20 Feb 2024
- Start date
- 18 Apr 2024
- Primary completion date
- 28 Jul 2025
- Lead sponsor
- Steno Diabetes Center Copenhagen
- NCT number
- NCT06330194
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 18 Apr 2024 to the primary completion date, 28 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with sulphonylureas in pre-dialysis participants (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines)
- Systemic steroid treatment within 4 weeks (stable doses of steroids \>8 weeks allowed)
Other illness
- History of ketoacidosis within the past 6 months
- Moderate to severe cognitive impairment
- Major allergy to tape/ adhesives
- Major psychiatric history
- Visual impairment
Lab values
- 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)
Other
- Women who are pregnant or planning pregnancy
- Life-expectancy to \<6 months
Who the study is looking for
- Written informed consent obtained before any trial-related procedures are performed
- 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)
- Maintenance HD, PD, or CKD stage 3b-5 (not on dialysis).
- Subject must be willing and able to comply with trial protocol
- HbA1c \<91 mmol/mol (10.5%)
- All participants will require to have internet or mobile phone access enabling upload of the AID system data to cloud based software.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tobias Bomholt Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
Related publications
- The impact of automated insulin delivery on glucose management in people with diabetes and advanced chronic kidney disease.Diabetologia · 2026 · PMID 42108331
This page is information, not medical advice. Discuss any trial with your doctor.