Type 2 Diabetes, Chronic Kidney Disease 5D
Conditions
Keywords
Type 2 Diabetes, Haemodialysis, Chronic kidney diseases
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.
Interventions
DEVICEOmnipod 5
Omnipod 5 automated insulin delivery system
DEVICEInsulin injections
Usual insulin injections
Sponsors
Imperial College London
Guy's and St Thomas' NHS Foundation Trust
Manchester University NHS Foundation Trust
University Hospitals of Derby and Burton NHS Foundation Trust
King's College London
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years and older 2. Participant has insulin-treated type 2 diabetes on more than 1 insulin injection per day or insulin pump therapy 3. 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 4. If the participant uses a CGM, the baseline time spent between 3.9 to 10 mmol/L in the last 4 weeks is \<70% 5. For those not using CGM screening HbA1c \>7.0% (53 mmol/mol) and ≤ 12% (108 mmol/mol) 6. Total daily dose of insulin is \> 10 units and \<200 units per day 7. Literate in English for safe study conduct. 8. Willing to wear study glucose sensors and the AID system 9. Willing to follow study-specific instructions 10. Female participants of childbearing age should be on effective contraception, not sexually active / or have no plans for pregnancy 11. All patients whether transplant-wait listed or not, are eligible for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range 3.9 to 10 mmol/l | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent below target glucose (<3.9mmol/l) | 12 weeks | Time spent below target glucose (\<3.9mmol/l) |
| Time spent below target glucose (<3.0mmol/l) | 12 weeks | Time spent below target glucose (\<3.0mmol/l) |
| Severe hypoglycaemic episodes | 12 weeks | Severe hypoglycaemic episodes as defined by American Diabetes Association |
| Frequency of significant ketosis events (ketones >1.5) | 12 weeks | Frequency of significant ketosis events (ketones \>1.5) |
| Diabetes Treatment Satisfaction Questionnaire Score | 12 weeks | 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 |
| Quality of life (EQ-5D-5L) Score | 12 weeks | 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'. |
| Xerostomia Inventory (XI) Score | 12 weeks | 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). |
| Type 2 Diabetes Distress Assessment System (T2-DDAS) Score | 12 weeks | 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 |
| Frequency of significant ketosis events (ketones >3) | 12 weeks | Frequency of significant ketosis events (ketones \>3) |
| Dialysis Thirst Inventory (DTI) Score | 12 weeks | 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). |
Countries
United Kingdom
Contacts
CONTACTLalantha Leelarathna, PhD
Outcome results
None listed