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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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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.
Dialysis patients with diabetes have a very short life expectancy likely caused by a high incidence of co-morbidities combined with an increased risk of hypoglycaemia and poor glycaemic control. In the past decades various diabetes technologies have revolutionised treatment, primarily in type 1 diabetes, but have also shown effect in type 2 diabetes. The Automated Insulin Delivery (AID) system combines continuous glucose monitoring (CGM) with an insulin pump that automatically infuse short-acting insulin subcutaneously and has shown remarkable results in improving glucose levels. We hypothesise that the AID system can lead to a substantial improvement in glycaemic control for patients receiving haemodialysis (HD), peritoneal dialysis (PD) and patients with chronic kidney disease (CKD) stage 3b to 5 (not on dialysis).
The primary objective is to determine if the AID system is superior in regulating glucose levels, in people living with type 1 and type 2 diabetes, receiving HD, PD or having advanced CKD, compared with usual care. Secondary objectives are to evaluate the impact on life quality, incidence of hypoglycaemia and if this treatment is feasible for this population
This prospective, open-label, two-stage randomized-crossover study is conducted at the Department of Nephrology, Rigshospitalet Copenhagen and Steno Diabetes Center Copenhagen. The study is performed in collaboration with six Australian centres (St Vincent's Melbourne, Royal Melbourne, Austin, Cairns Base, Flinders, and Canberra Hospitals).
A total of 15 participants will be recruited in Copenhagen, with participants evenly distributed across the three disease categories (HD, PD, and advanced CKD). Data collected from Copenhagen will be pooled with data obtained from the Australian centers.
Participants entering the study will have a four-to-six-week run-in phase with diabetes education (carbohydrate counting, inserting of CGM etc). Training will consist of three sessions of 2-4 hours with a dedicated diabetes nurse. During the run-in phase three weeks of unblinded CGM will be performed to assess baseline glucose levels. All participants will be randomized 1:1 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.
The trial will be conducted in compliance with the Good Clinical Practice (GCP) guidelines, and written informed consent will be obtained before any trial activities are performed. The project including a plan for the handling of personal information will be approved by the Danish Data Protection Agency before initiation. If necessary, the Danish Medicines Agency and the responsible GCP unit will be granted access to journals, documents, and other materials relevant to the project. All participants will be assigned with a subject number and will be recorded on data sheets. Only tubes will appear with subject number and trial ID. Information on full name and social security and subject numbers will be stored separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | 2nd Generation Automated Insulin Delivery system (Medtronic MiniMed 780G) |
|
| Control Group | No Intervention | Usual care consisting of participants current insulin-treatment (either multiple daily injection with insulin or traditional insulin pump therapy with manual determination of insulin dosing) and real-time CGM if already used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2nd Generation Automated Insulin Delivery (AID) system | Device | The AID system will initially commence delivery by insulin pump post-randomisation without the AID in operation and with predictive low glucose suspend activated for a period of two weeks. Once safety has been established, the autocorrect function can be activated and the setpoint reduced to 5.5 mmol/L. Throughout the study insulin pump uploads will be reviewed twice weekly initially and at least weekly thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time in sensor glucose target range (3.9-10.0 mmol/L) | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of time spent <2.8 mmol/L | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Proportion of time spent <3.0 mmol/L |
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Inclusion Criteria:
All participants will require to have internet or mobile phone access enabling upload of the AID system data to cloud based software.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Bomholt, MD, PhD | Department of Nephrology, Rigshospitalet, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobias Bomholt | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42108331 | Derived | Lu JC, Meyer-Olesen CL, Halim B, Vogrin S, Christensen MB, Apostolopoulos J, Bomholt T, MacIsaac RJ, Lee P, Trawley S, Cohen N, Fourlanos S, Stranks S, Jenkins AJ, Ekinci E, Hornum M, Norgaard K, O'Neal DN. The impact of automated insulin delivery on glucose management in people with diabetes and advanced chronic kidney disease. Diabetologia. 2026 Aug;69(8):2168-2181. doi: 10.1007/s00125-026-06732-3. Epub 2026 May 11. |
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Design: Prospective, open-label, two-stage randomised-crossover study.
Population: Patients with type 1 or type 2 diabetes undergoing hemodialysis (n=5), peritoneal dialysis (n=5) or chronic kidney disease stage 3b to stage 5 (n=5).
Methods: Participants entering the study will have a four-to-six-week run-in phase with diabetes education. During the run-in phase three weeks of unblinded continous glucose monitoring (CGM) will be performed to assess baseline glucose levels.
All participants will be randomized to receive either eight weeks with an advanced insulin delivery (AID) System or eight weeks of control (usual care) with cross over at the end of the first eight weeks.
CGM study outcome data will be collected by identical methods, using unblinded-CGM devices, for participants in both intervention and control study arms.
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Assessed by 3 continuous weeks of CGM
| End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Proportion of time spent <3.3 mmol/L | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Proportion of time spent <3.9 mmol/L | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Proportion of time spent 3.9-7.8 | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Proportion of time spent >10.0 mmol/L | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Proportion of time spent >13.9 mmol/L | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Proportion of time spent >16.7 mmol/L | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Glucose variability (SD and coefficient of variation) | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Mean glucose | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| HbA1c | Blood sample | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes | Assessed by 3 continuous weeks of CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia | Hospital presentations with either of the above | Week 0-22 |
| eGFR (estimated glomerular filtration rate) | Based on serum creatinine measurements, using the CKD-EPI equation. Only measured in patients from the CKD-group | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Potassium pre-dialysis | Blood sample. Only measured in patients from the HD-group | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Urine albumine-to-creatinine ratio | Urine sample. Only measured in patients from the CKD-group | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Actigraph Metrics for sleep architecture | Used concurrently with the CGM | End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22 |
| Sleep diary | Week 6-22 |
| Proportion of time Automode is active | Registered through uploads from insulin pump in the intervention arm | Weekly assessed: week 6-22 |
| Diabetic ketoacidosis | Week 0-22 |
| Severe hypoglycemia | Requiring third party assistance | Week 0-22 |
| Serious Adverse Event | Week 0-22 |
| Unanticipated Serious Adverse Device Event | Week 0-22 |
| Satisfaction with diabetes treatment | Questionnaire: The Diabetes Treatment Satisfaction Questionnaire status [DTSQs] | Enrollment visit: week 0; end of phase 1: week 14; end of phase 2: week 22 |
| Satisfaction with diabetes treatment | Questionnaire: The Diabetes Treatment Satisfaction Questionnaire control version [DTSQc] | End of phase 1: week 14; end of phase 2: week 22 |
| Fear of hypoglycaemia | Questionnaire: Hypoglycaemia Fear Survey [HFS-II] | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Hypoglycaemia awareness | Questionnaire: Gold Score and Clarke Score | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Diabetes distress | Questionnaire: Problem Areas in Diabetes [PAID] | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Sleep Quality | Questionnaire: Pittsburgh Sleep Quality Index [PSQI] | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Cognitive function | Questionnaire: Montreal Cognitive Assessment (MOCA) | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Sarcopenia | SARC-F questionnaire | End of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Semi-structured interview | Influence of kidney disease on diabetes management and experience with the AID. Only performed in intervention arm. | End of phase 1: week 14; end of phase 2: week 22 |
| Health-related quality of life | Questionnaire: EQ-5D | Enrollment visit: week 0; end of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| Frailty | Questionnaire: Fried Frailty | End of run in phase: week 6; end of phase 1: week 14; end of phase 2: week 22 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007316 | Insemination, Artificial, Heterologous |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D004358 | Drug Therapy |
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