A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis

NCT07422532 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 173303NIHR207915
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

Brief Summary

Diabetes is the leading cause of kidney failure in the UK. Many people with diabetes and advanced kidney failure inject themselves with insulin and do finger-prick blood glucose tests. Managing diabetes in people with advanced kidney disease is challenging, with fluctuating glucose levels and an increased risk of unsafe low glucose levels. We now have continuous glucose monitors (CGM), which allow people to monitor glucose without painful fingerprick tests. CGM can be combined with insulin pumps to create automated insulin delivery systems (AID) that automatically deliver insulin to control glucose levels. AID systems are currently used in people with type 1 diabetes, but they are not used in people with type 2 diabetes. There is little information on how these systems might help people with diabetes and advanced kidney failure, and on dialysis. This study will investigate whether automated insulin delivery can improve glucose levels and quality of life in people with type 2 diabetes treated with more than one insulin injection with advanced kidney failure and undergoing regular haemodialysis treatment. This study will be conducted in four UK centres and will be of a parallel design. We estimate that the trial will require 84 participants to be recruited, and 76 participants to be randomised. We aim for 64 participants across both groups to complete the trial. Participants will wear a glucose sensor at the start. In random order, half will be randomised to AID treatment while the other half will continue usual care augmented with continuous glucose monitoring. The duration of each treatment stage is 12 weeks. The study will last about 18 weeks for each participant. We will compare the glucose levels in the AID group with the usual care group to see if there is a difference. Questionnaires and interviews will help us understand participants' experiences. We will carefully monitor the safety of the participants.

Conditions

Type 2 Diabetes; Chronic Kidney Disease 5D

Keywords

Type 2 Diabetes; Haemodialysis; Chronic kidney diseases

Outcome Measures

Primary Outcomes (1)

• Time in range 3.9 to 10 mmol/l

  Glucose time in range (TIR), % of readings between 3.9 to 10.0 mmol/l based on sensor glucose levels, from randomisation to 12 weeks

  12 weeks

Secondary Outcomes (10)

• Time spent below target glucose (<3.9mmol/l)

  12 weeks

• Time spent below target glucose (<3.0mmol/l)

  12 weeks

• Severe hypoglycaemic episodes

  12 weeks

• Frequency of significant ketosis events (ketones >1.5)

  12 weeks

• Diabetes Treatment Satisfaction Questionnaire Score

  12 weeks

Other Outcomes (9)

• Death

  12 weeks

• Time above range > 10 mmol/L

  12 weeks

• Time above range > 13.9 mmol/L

  12 weeks

Study Arms (2)

Control group (Usual Care)

PLACEBO COMPARATOR

Usual insulin injections

Device: Insulin injections

Intervention Arm

ACTIVE COMPARATOR

Omnipod 5

Device: Omnipod 5

Interventions

Omnipod 5 DEVICE

Omnipod 5 automated insulin delivery system

Intervention Arm

Insulin injections DEVICE

Usual insulin injections

Control group (Usual Care)

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and older
• Participant has insulin-treated type 2 diabetes on more than 1 insulin injection per day or insulin pump therapy
• Participant has ESKD and is established on out-patient hospital-based haemodialysis treatment at least 3 times a week, via an arterio-venous fistula, graft or central venous catheter
• If the participant uses a CGM, the baseline time spent between 3.9 to 10 mmol/L in the last 4 weeks is \<70%
• For those not using CGM screening HbA1c \>7.0% (53 mmol/mol) and ≤ 12% (108 mmol/mol)
• Total daily dose of insulin is \> 10 units and \<200 units per day
• Literate in English for safe study conduct.
• Willing to wear study glucose sensors and the AID system
• Willing to follow study-specific instructions
• Female participants of childbearing age should be on effective contraception, not sexually active / or have no plans for pregnancy

You may not qualify if:

• Any other physical disease or people with known severe mental illness (psychotic disorder, bipolar disorder, dementia, substance and alcohol dependence, learning disabilities, active suicidal ideation) that are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
• Either current use of peritoneal dialysis or planned modality transfer (transplantation from a live donor with a confirmed date, peritoneal dialysis or conservative care) in the next 18 weeks
• Only treated with background (basal) insulin
• The participant is currently on AID or more than 2 weeks use of AID in the last 4 weeks
• Known or suspected allergy against insulin
• Treated with sulphonylureas (use of SGLT2 inhibitors are allowed)
• Treated with hydroxyurea (sensor interference)
• Presence of unstable retinopathy per Investigator's judgement
• Severe bilateral visual impairment

Sponsors & Collaborators

• Imperial College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Manchester University NHS Foundation Trust: collaborator
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator
• King's College London: collaborator
• University of Nottingham: collaborator

Study Sites (4)

Royal Derby Hospital

Derby, United Kingdom

Location

Guys and St Thomas' Hospitals

London, United Kingdom

Location

Hammersmith Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Related Publications (1)

• Lu JC, Lee P, Ierino F, MacIsaac RJ, Ekinci E, O'Neal D. Challenges of Glycemic Control in People With Diabetes and Advanced Kidney Disease and the Potential of Automated Insulin Delivery. J Diabetes Sci Technol. 2024 Nov;18(6):1500-1508. doi: 10.1177/19322968231174040. Epub 2023 May 10.

  PMID: 37162092 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; 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

Central Study Contacts

Lalantha Leelarathna, PhD

CONTACT

+44 7984477771; lalantha.leelarathna@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-label, multi-centre, randomised, parallel-design, superiority trial using a commercially available CE-marked AID system (Omnipod 5) for 12 weeks compared with usual insulin therapy plus continuous glucose monitoring.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)