An interventional study of Omnipod 5 and Insulin injections in Type 2 Diabetes and Chronic Kidney Disease 5D, sponsored by Imperial College London. Not yet recruiting at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Imperial College London · Not applicable, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 84 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria
Usual insulin injections
Device: Insulin injections
Omnipod 5
Device: Omnipod 5
Omnipod 5 automated insulin delivery system
Usual insulin injections
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
Time frame: 12 weeks
Time spent below target glucose (<3.9mmol/l)
Time spent below target glucose (\<3.9mmol/l)
Time frame: 12 weeks
Time spent below target glucose (<3.0mmol/l)
Time spent below target glucose (\<3.0mmol/l)
Time frame: 12 weeks
Severe hypoglycaemic episodes
Severe hypoglycaemic episodes as defined by American Diabetes Association
Time frame: 12 weeks
Frequency of significant ketosis events (ketones >1.5)
Frequency of significant ketosis events (ketones \>1.5)
Time frame: 12 weeks
Diabetes Treatment Satisfaction Questionnaire Score
The DTSQ is a validated, 8-item measure that evaluates respondents' satisfaction with their diabetes treatment using a 7-point Likert scale. It consists of six questions about diabetes treatment and two questions regarding the burden of hypo- and hyperglycaemia. Treatment satisfaction is scored from 0 to 36 based on the responses to the first six questions, with higher scores indicating greater satisfaction with treatment
Time frame: 12 weeks
Quality of life (EQ-5D-5L) Score
The EQ-5D-5L consists of two parts. The EQ-5D descriptive system is a non-disease-specific measure of health-related quality of life. Respondents evaluate their perceived health status across five dimensions, each with five levels. The results from these five dimensions can be combined into a five-digit number that describes the respondent's perceived health state. The second part is the EQ VAS, where respondents record their self-rated health on a vertical visual analogue scale with endpoints labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: 12 weeks
Xerostomia Inventory (XI) Score
The Xerostomia Inventory (XI) assesses oral dryness and comprises 11 items, each rated on a five-point Likert scale (never = 1, to very often = 5). The responses to these 11 items are summed, resulting in an individual XI score for each patient that ranges from 11 (no dry mouth) to 55 (extremely dry mouth).
Time frame: 12 weeks
Type 2 Diabetes Distress Assessment System (T2-DDAS) Score
Type 2 Diabetes Distress Assessment System (T2-DDAS) - The T2-DDAS is a validated 8-item measure of diabetes distress, where respondents answer each question on a 5-point Likert scale. The core distress score is the average of the eight items on the core scale, with each item rated from 1 to 5. Mean score \<2.0 indicate little or no distress Mean score ≥2.0 but not more than 2.9 indicates moderate distress Mean score ≥3.0 indicate high distress Any score \> 2.0 is considered clinically significant
Time frame: 12 weeks
Frequency of significant ketosis events (ketones >3)
Frequency of significant ketosis events (ketones \>3)
Time frame: 12 weeks
Dialysis Thirst Inventory (DTI) Score
Dialysis Thirst Inventory (DTI) - The DTI is a questionnaire that measures perceived thirst in individuals undergoing dialysis. It contains seven items, each with a five-point Likert-type scale (never = 1, to very often = 5). The scores are summed to produce a DTI score ranging from seven (no thirst) to 35 (very thirsty).
Time frame: 12 weeks
Death
Death
Time frame: 12 weeks
Time above range > 10 mmol/L
Time above range \> 10 mmol/L
Time frame: 12 weeks
Time above range > 13.9 mmol/L
Time above range \> 13.9 mmol/L
Time frame: 12 weeks
Mean glucose levels
Mean glucose levels
Time frame: 12 weeks
Coefficient of variation of glucose levels
Coefficient of variation of glucose levels
Time frame: 12 weeks
Total Daily Dose of Insulin
Total Daily Dose of Insulin
Time frame: 12 weeks
Ultrafiltration volume
Ultrafiltration volume
Time frame: 12 weeks
Interdialytic weight gain
Interdialytic weight gain
Time frame: 12 weeks
Percentage of time auto-mode use
Percentage of time auto-mode use
Time frame: 12 weeks
Plan to share: No
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Imperial College London