Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:43 PM
Study NCT ID:
NCT07422532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Death', 'timeFrame': '12 weeks', 'description': 'Death'}, {'measure': 'Time above range > 10 mmol/L', 'timeFrame': '12 weeks', 'description': 'Time above range \\> 10 mmol/L'}, {'measure': 'Time above range > 13.9 mmol/L', 'timeFrame': '12 weeks', 'description': 'Time above range \\> 13.9 mmol/L'}, {'measure': 'Mean glucose levels', 'timeFrame': '12 weeks', 'description': 'Mean glucose levels'}, {'measure': 'Coefficient of variation of glucose levels', 'timeFrame': '12 weeks', 'description': 'Coefficient of variation of glucose levels'}, {'measure': 'Total Daily Dose of Insulin', 'timeFrame': '12 weeks', 'description': 'Total Daily Dose of Insulin'}, {'measure': 'Ultrafiltration volume', 'timeFrame': '12 weeks', 'description': 'Ultrafiltration volume'}, {'measure': 'Interdialytic weight gain', 'timeFrame': '12 weeks', 'description': 'Interdialytic weight gain'}, {'measure': 'Percentage of time auto-mode use', 'timeFrame': '12 weeks', 'description': 'Percentage of time auto-mode use'}], 'primaryOutcomes': [{'measure': 'Time in range 3.9 to 10 mmol/l', 'timeFrame': '12 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Time spent below target glucose (<3.9mmol/l)', 'timeFrame': '12 weeks', 'description': 'Time spent below target glucose (\\<3.9mmol/l)'}, {'measure': 'Time spent below target glucose (<3.0mmol/l)', 'timeFrame': '12 weeks', 'description': 'Time spent below target glucose (\\<3.0mmol/l)'}, {'measure': 'Severe hypoglycaemic episodes', 'timeFrame': '12 weeks', 'description': 'Severe hypoglycaemic episodes as defined by American Diabetes Association'}, {'measure': 'Frequency of significant ketosis events (ketones >1.5)', 'timeFrame': '12 weeks', 'description': 'Frequency of significant ketosis events (ketones \\>1.5)'}, {'measure': 'Diabetes Treatment Satisfaction Questionnaire Score', 'timeFrame': '12 weeks', 'description': "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"}, {'measure': 'Quality of life (EQ-5D-5L) Score', 'timeFrame': '12 weeks', 'description': "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'."}, {'measure': 'Xerostomia Inventory (XI) Score', 'timeFrame': '12 weeks', 'description': '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).'}, {'measure': 'Type 2 Diabetes Distress Assessment System (T2-DDAS) Score', 'timeFrame': '12 weeks', 'description': '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.\n\nMean 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'}, {'measure': 'Frequency of significant ketosis events (ketones >3)', 'timeFrame': '12 weeks', 'description': 'Frequency of significant ketosis events (ketones \\>3)'}, {'measure': 'Dialysis Thirst Inventory (DTI) Score', 'timeFrame': '12 weeks', 'description': '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).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Haemodialysis', 'Chronic kidney diseases'], 'conditions': ['Type 2 Diabetes', 'Chronic Kidney Disease 5D']}, 'referencesModule': {'references': [{'pmid': '37162092', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 18 years and older\n2. Participant has insulin-treated type 2 diabetes on more than 1 insulin injection per day or insulin pump therapy\n3. 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\n4. If the participant uses a CGM, the baseline time spent between 3.9 to 10 mmol/L in the last 4 weeks is \\<70%\n5. For those not using CGM screening HbA1c \\>7.0% (53 mmol/mol) and ≤ 12% (108 mmol/mol)\n6. Total daily dose of insulin is \\> 10 units and \\<200 units per day\n7. Literate in English for safe study conduct.\n8. Willing to wear study glucose sensors and the AID system\n9. Willing to follow study-specific instructions\n10. Female participants of childbearing age should be on effective contraception, not sexually active / or have no plans for pregnancy\n11. All patients whether transplant-wait listed or not, are eligible for inclusion.\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. 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\n2. 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\n3. Only treated with background (basal) insulin\n4. The participant is currently on AID or more than 2 weeks use of AID in the last 4 weeks\n5. Known or suspected allergy against insulin\n6. Treated with sulphonylureas (use of SGLT2 inhibitors are allowed)\n7. Treated with hydroxyurea (sensor interference)\n8. Presence of unstable retinopathy per Investigator's judgement\n9. Severe bilateral visual impairment\n10. 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"}, 'identificationModule': {'nctId': 'NCT07422532', 'acronym': 'AID-HD', 'briefTitle': 'A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '173303'}, 'secondaryIdInfos': [{'id': 'NIHR207915', 'type': 'OTHER_GRANT', 'domain': 'National Institute for Health and Care Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group (Usual Care)', 'description': 'Usual insulin injections', 'interventionNames': ['Device: Insulin injections']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Arm', 'description': 'Omnipod 5', 'interventionNames': ['Device: Omnipod 5']}], 'interventions': [{'name': 'Omnipod 5', 'type': 'DEVICE', 'description': 'Omnipod 5 automated insulin delivery system', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Insulin injections', 'type': 'DEVICE', 'description': 'Usual insulin injections', 'armGroupLabels': ['Control group (Usual Care)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Derby', 'country': 'United Kingdom', 'contacts': [{'name': 'Emma Wilmot, PhD', 'role': 'CONTACT', 'email': 'emma.wilmot2@nhs.net'}], 'facility': 'Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Janaka Karalliedde, PhD', 'role': 'CONTACT', 'email': 'janaka.karalliedde@kcl.ac.uk'}, {'name': 'Janaka Karalliedde, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guys and St Thomas' Hospitals", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Lalantha Leelarathna, PhD', 'role': 'CONTACT', 'email': 'lalantha.leelarathna@nhs.net'}], 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'contacts': [{'name': 'Hood Thabit, PhD', 'role': 'CONTACT', 'email': 'hood.thabit@mft.nhs.uk'}], 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Lalantha Leelarathna, PhD', 'role': 'CONTACT', 'email': 'lalantha.leelarathna@nhs.net', 'phone': '+44 7984477771'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': 'University Hospitals of Derby and Burton NHS Foundation Trust', 'class': 'OTHER'}, {'name': "King's College London", 'class': 'OTHER'}, {'name': 'University of Nottingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}