Type 2 DiabetesAID-HDNCT07422532
A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis
A study testing Omnipod 5 and Insulin injections in people with Type 2 Diabetes and Chronic Kidney Disease 5D, run by Imperial College London at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Disease 5D
- What is being tested?
- Omnipod 5 and Insulin injections
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Sep 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- All patients whether transplant-wait listed or not, are eligible for inclusion.
Who cannot join
- 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)
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- Treated with hydroxyurea (sensor interference)
- Presence of unstable retinopathy per Investigator's judgement
- Severe bilateral visual impairment
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites, 4 recruiting
- Recruiting
Royal Derby Hospital
Derby
Emma Wilmot, PhD, emma.wilmot2@nhs.net
- Recruiting
Guys and St Thomas' Hospitals
London
Janaka Karalliedde, PhD, janaka.karalliedde@kcl.ac.uk
Janaka Karalliedde, PhD
- Recruiting
Hammersmith Hospital
London
Lalantha Leelarathna, PhD, lalantha.leelarathna@nhs.net
- Recruiting
Manchester Royal Infirmary
Manchester
Hood Thabit, PhD, hood.thabit@mft.nhs.uk
About this study
Official title: An Open-label, Multi-centre, Randomised Controlled Trial to Assess the Efficacy, Safety and Utility of Automated Insulin Delivery in People With Type 2 Diabetes and Sub-optimal Glycaemia Undergoing Haemodialysis
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
- Being tested
- Omnipod 5, Insulin injections
- Keywords
- Type 2 Diabetes, Haemodialysis, Chronic kidney diseases
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod 5Device
Omnipod 5 automated insulin delivery system
Insulin injectionsDevice
Usual insulin injections
| Study group | Role | What they receive |
|---|---|---|
| Control group (Usual Care) | Placebo comparator | Usual insulin injections Receives: Device: Insulin injections |
| Intervention Arm | Active comparator | Omnipod 5 Receives: Device: Omnipod 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (10)
Time spent below target glucose (<3.9mmol/l)
Time spent below target glucose (<3.9mmol/l)
Measured: 12 weeks
Time spent below target glucose (<3.0mmol/l)
Time spent below target glucose (<3.0mmol/l)
Measured: 12 weeks
Severe hypoglycaemic episodes
Severe hypoglycaemic episodes as defined by American Diabetes Association
Measured: 12 weeks
Frequency of significant ketosis events (ketones >1.5)
Frequency of significant ketosis events (ketones >1.5)
Measured: 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
Measured: 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'.
Measured: 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).
Measured: 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
Measured: 12 weeks
Frequency of significant ketosis events (ketones >3)
Frequency of significant ketosis events (ketones >3)
Measured: 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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Sep 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422532
- Sponsor's protocol ID
- 173303
- Other IDs
- NIHR207915
- Acronym
- AID-HD
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37162092
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-centre, Randomised Controlled Trial to Assess the Efficacy, Safety and Utility of Automated Insulin Delivery in People With Type 2 Diabetes and Sub-optimal Glycaemia Undergoing Haemodialysis
- ClinicalTrials.gov ID
- NCT07422532
- Acronym / sponsor ID
- AID-HD / 173303
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease 5D
- Keywords
- Type 2 Diabetes, Haemodialysis, Chronic kidney diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- 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 start
- 1 Sep 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group (Usual Care) | Placebo comparator | Device: Insulin injectionsUsual insulin injections |
| Intervention Arm | Active comparator | Device: Omnipod 5Omnipod 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnipod 5Omnipod 5 automated insulin delivery system | Device | Intervention Arm |
| Insulin injectionsUsual insulin injections | Device | Control group (Usual Care) |
Primary outcome
Time in range 3.9 to 10 mmol/l
Time frame: 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
10 secondary outcomes
Time spent below target glucose (<3.9mmol/l)
Time frame: 12 weeks
Time spent below target glucose (<3.0mmol/l)
Time frame: 12 weeks
Severe hypoglycaemic episodes
Time frame: 12 weeks
Frequency of significant ketosis events (ketones >1.5)
Time frame: 12 weeks
Diabetes Treatment Satisfaction Questionnaire Score
Time frame: 12 weeks
Quality of life (EQ-5D-5L) Score
Time frame: 12 weeks
Xerostomia Inventory (XI) Score
Time frame: 12 weeks
Type 2 Diabetes Distress Assessment System (T2-DDAS) Score
Time frame: 12 weeks
Frequency of significant ketosis events (ketones >3)
Time frame: 12 weeks
Dialysis Thirst Inventory (DTI) Score
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 37162092Lu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnipod 5 and Insulin injections in people with Type 2 Diabetes and Chronic Kidney Disease 5D, run by Imperial College London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lalantha Leelarathna, PhD (+44 7984477771, lalantha.leelarathna@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range 3.9 to 10 mmol/l (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07422532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.