Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease

NCT06330194 | Completed

• 1 other identifier: AID-study
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hemodialysis; Peritoneal Dialysis; Dialysis; Chronic Kidney Disease

Keywords

Insulin Infusion Systems; Continuous Glucose Monitoring; Randomized Controlled Trial; Equipment Safety; Glycemic Control; Time-in-range

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (34)

• Proportion of time spent <2.8 mmol/L

  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

  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

  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

  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

  End of run in phase: week 3-5; end of phase 1: week 11-13; end of phase 2: week 20-22

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

2nd Generation Automated Insulin Delivery system (Medtronic MiniMed 780G)

Device: 2nd Generation Automated Insulin Delivery (AID) system

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.

Interventions

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.

Also known as: Medtronic MiniMed 780G

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of ketoacidosis within the past 6 months
• Moderate to severe cognitive impairment
• Major allergy to tape/ adhesives
• Women who are pregnant or planning pregnancy
• Life-expectancy to \<6 months
• Major psychiatric history
• Treatment with sulphonylureas in pre-dialysis participants (SGLT2 inhibitors, metformin, and GLP1 analogues may be used within regulatory guidelines)
• 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)
• Systemic steroid treatment within 4 weeks (stable doses of steroids \>8 weeks allowed)
• Visual impairment

Sponsors & Collaborators

• Rigshospitalet, Denmark: collaborator
• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Tobias Bomholt

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Interventions

Insemination, Artificial, Heterologous; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Drug Therapy

Study Officials

• Tobias Bomholt, MD, PhD

  Department of Nephrology, Rigshospitalet, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tobias Bomholt, MD, PhD, Post.doc.

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 26, 2024
• Study Start: April 18, 2024
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)