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

NCT07422532 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-02-20

No results posted yet for this study

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

Interventions

DEVICE

Omnipod 5

Omnipod 5 automated insulin delivery system

DEVICE

Insulin injections

Usual insulin injections

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • University Hospitals of Derby and Burton NHS Foundation Trust

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • Imperial College London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07422532 on ClinicalTrials.gov