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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices
Recent advances in insulin pumps, continuous glucose monitoring (CGM) devices, and control algorithms have resulted in an acceleration of progress in the development of the automated systems of insulin delivery including advanced hybrid closed loop (HCL) insulin pumps. The results of the AHCL insulin pump based studies published so far are very encouraging, including that Medtronic-sponsored study performed at our center "Transition of CSII/CGM naïve patients directly into AHCL (780G) insulin pump: the impact on glucose patterns and quality of life measures" (1-6). Unfortunately there is little data concerning the usage of AHCL systems in older patients. The management of these individuals is particularly challenging as older adults with type 1 diabetes are especially vulnerable to hypoglycaemia. The recent ADA/EASD consensus underlines that the use of advanced technologies in older individuals is useful and should not be discontinued or a priori excluded because of the older age (7). Since the AHCL systems are very effective in hypoglycemia prevention they could be considered the treatment of choice in older patients with T1DM. The open question is how effectively would older individuals adopt this advanced technology, how would they accept it, and if the simplicity in terms of everyday usage of AHCL versus less advanced technologies would be appreciated by older individuals with T1DM. Older people with diabetes have a higher risk for cognitive impairment and for physical disability whether this may be effected by an improvement in glucose indices is unknown. Thus, the aim of this study is to assess the efficacy of AHCL in people with type 1 diabetes in improving glucose indices, quality of life and physical capacity indices
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actual therapy | No Intervention | The patient continues Multiple Daily Injection/Insulin Pump Therapy with or without CGM use as per routine procedures | |
| Advanced Hybrid Cloosed Loop System | Experimental | The patients will be switched to MiniMed 780G advanced hybrid cloosed loop system/ AHCL system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMed 780G system | Device | The MiniMedâ„¢ 780G system automatically adjust insulin delivery to patient needs for an easier way to stabilise glucose levels. It features an advance level of automation for diabetes management, known as SmartGuardâ„¢ technology. If patient glucose levels are trending high, it gives patient more insulin. Technology is CE marked. |
| Measure | Description | Time Frame |
|---|---|---|
| Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L). | Between group difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (TIR) (3.9-10.0 mmol/L). | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Between groups difference in the percentage of participants achieving TIR >70% | Between groups difference in the percentage of participants achieving TIR >70% | Month 12 |
| Between group difference in the percentage of time spent in hyperglycemic range with SG > 250 mg/dL (13.9 mmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Klupa, Prof. | Jagiellonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital University; Jagiellonian University Medical College | Krakow | 30688 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42347980 | Derived | Matejko B, Cyranka K, Sudul P, Susul K, Krezel J, Chernovol J, Maga P, Malecki MT, Klupa T. Metabolic and vascular outcomes after transition to the MiniMed 780G system in adults >/=65 years with type 1 diabetes: a randomised, single-centre study. Diabetologia. 2026 Jun 25. doi: 10.1007/s00125-026-06780-9. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2022 | May 16, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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The trial is a two-centers, randomized controlled, parallel group study
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|
Between group difference in the percentage of time spent with SG > 250 mg/dL (13.9 mmol/L) |
| Month 12 |
| Between group difference in the percentage of time spent in hyperglycemic range with SG > 180 mg/dL (10.0 mmol/L) | Between group difference in the percentage of time spent with SG > 180 mg/dL (10.0 mmol/L) | Month 12 |
| Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L) | Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L) | Month 12 |
| Between group difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L) | Between group difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L) | Month 12 |
| QoL group difference using: The World Health Organisation- Five Well-Being Index (WHO-5) | QoL group difference (WHO-5): Final score: 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. | Month 12 |
| Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry | Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry | Month 12 |
| Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation | Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation | Month 12 |
| Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness | Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness, | Month 12 |
| Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test | Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test (units distance in meters, higher value mean a better outcome) | Month 12 |
| Difference in physical capacity indices listed in screening visit: Fried Scale | Difference in physical capacity indices listed in screening visit: Fried Scale (higher scores mean a worse outcome, score >3 frail present) | Month 12 |
| Difference in physical capacity indices listed in screening visit: Berg Balance Scale | Difference in physical capacity indices listed in screening visit: Berg Balance Scale (higher score mean a better outcome) | Month 12 |
| Difference in physical capacity indices listed in screening visit: Four Square Step | Difference in physical capacity indices listed in screening visit:Four Square Step (units time, shorter time means better outcome) | Month 12 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |