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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 hard, with fluctuating glucose levels and an increased risk of unsafe low glucose levels.
There are currently 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 deliver insulin automatically to control glucose. 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 diabetes treated with more than one insulin injection with advanced kidney failure and/or undergoing regular dialysis treatment. This study will be a feasibility study conducted in a single centre (Imperial College, London) and be of a cross-over design. The study will aim to complete 12 people. Participants will wear a glucose sensor at the start. In random order, half will start AID followed by the usual treatment, while the other half will start the usual treatment followed by AID treatment. The duration of each treatment stage is eight weeks. The study will last about 22 weeks for each participant. Investigators 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. Investigators will carefully monitor the safety of participants.
This will be a single-centre, prospective, open-label, two-stage, randomized crossover study comparing automated subcutaneous insulin delivery (AID), also known as Hybrid Closed Loop (HCL) therapy using the 780G system with usual insulin therapy plus continuous glucose monitoring (CGM) in people with type 1 and type 2 diabetes complicated by advanced renal disease and managed with insulin. The study will be conducted at Imperial College Healthcare NHS Trust.
Duration of each treatment arm is 8 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated insulin delivery using Medtronic 780G System | Experimental |
| |
| Usual care plus continuous glucose monitoring | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic 780G System | Device | Automated insulin delivery using Medtronic 780G system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent time in sensor glucose target range (3.9-10.0 mmol/L) | Percent time in sensor glucose target range (3.9-10.0 mmol/L) with Automated Insulin Delivery (AID) versus Usual Care measured during the final 3 weeks of each study stage. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time in sensor glucose target range (<3.0 mmol/L) | Percent time in sensor glucose target range (<3.0 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Percent time in sensor glucose target range (<3.9 mmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lalantha Leelarathna, FRCP PhD | Contact | +447984477771 | e.leelarathna@imperial.ac.uk | |
| Nick Oliver, FRCP PhD | Contact | nick.oliver@imperial.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | M13 9WL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34349267 | Background | Boughton CK, Tripyla A, Hartnell S, Daly A, Herzig D, Wilinska ME, Czerlau C, Fry A, Bally L, Hovorka R. Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial. Nat Med. 2021 Aug;27(8):1471-1476. doi: 10.1038/s41591-021-01453-z. Epub 2021 Aug 4. | |
| 31133457 |
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No plans to share IPD
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
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| Continuous Glucose Monitoring | Device | Usual care with continuous glucose monitoring |
|
Percent time in sensor glucose target range (<3.9 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage |
| 3 weeks |
| Percent time in sensor glucose target range (>10 mmol/L) | Percent time in sensor glucose target range (<10 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Percent time in sensor glucose target range (<2.8 mmol/L) | Percent time in sensor glucose target range (<2.8 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Percent time in sensor glucose target range (<3.3 mmol/L) | Percent time in sensor glucose target range (<3.3 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Percent time in sensor glucose target range (>13.9 mmol/L) | Percent time in sensor glucose target range (<13.9 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Percent time in sensor glucose target range (>16.7 mmol/L) | Percent time in sensor glucose target range (<16.7 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Percent time in sensor glucose target range (3.9-7.8 mmol/L) | Percent time in sensor glucose target range (3.9-7.8 mmol/L) with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Mean sensor glucose | Mean sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| Standard deviation and coefficient of variation of sensor glucose | Standard deviation and coefficient of variation of sensor glucose with AID versus Usual Care, measured during the final 3 weeks of each study stage | 3 weeks |
| The Diabetes Treatment Satisfaction Questionnaire status | The Diabetes Treatment Satisfaction Questionnaire status with AID versus Usual Care | 8 weeks |
| Hypoglycaemia Fear Survey | Hypoglycaemia Fear Survey with AID versus Usual Care | 8 weeks |
| EQ-5D-5L | EQ-5D-5L with AID versus Usual Care | 8 weeks |
| Episodes of CGM time in <3.0mmol/L range lasting >15minutes | Episodes of CGM time in <3.0mmol/L range lasting >15minutes with AID versus Usual Care | 3 weeks |
| Number of hospital admissions with diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycaemia | Number of hospital admissions with diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycaemia with AID versus Usual Care | 8 weeks |
| Number of hospitalised and non-hospitalised patients with severe hypoglycaemia | Number of hospitalised and non-hospitalised patients with severe hypoglycaemia with AID versus Usual Care | 8 weeks |
| Bally L, Gubler P, Thabit H, Hartnell S, Ruan Y, Wilinska ME, Evans ML, Semmo M, Vogt B, Coll AP, Stettler C, Hovorka R. Fully closed-loop insulin delivery improves glucose control of inpatients with type 2 diabetes receiving hemodialysis. Kidney Int. 2019 Sep;96(3):593-596. doi: 10.1016/j.kint.2019.03.006. Epub 2019 Mar 20. |
| 37162092 | Background | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |