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

N/ANot Yet RecruitingNCT07422532

Imperial College London84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: Exclusion Criteria 1. 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 2. 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 3. Only treated with background (basal) insulin 4. The participant is currently on AID or more than 2 weeks use of AID in the last 4 weeks 5. Known or suspected allergy against insulin 6. Treated with sulphonylureas (use of SGLT2 inhibitors are allowed) 7. Treated with hydroxyurea (sensor interference) 8. Presence of unstable retinopathy per Investigator's judgement 9. Severe bilateral visual impairment 10. Pregnancy, planned pregnancy in the next 3 months or breastfeeding current or planned glucocorticoid use other than inhaled/ topical use. Stable long-term steroid use is not an exclusion

Locations (4)

Royal Derby Hospital

Derby, United Kingdom

Guys and St Thomas' Hospitals

London, United Kingdom

Hammersmith Hospital

London, United Kingdom

Manchester Royal Infirmary

Manchester, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts