NCT06207838

Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump

Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump: the Impact on Glucose Patterns, Quality of Life Physical & Cognitive Measures, as Well as Vascular Status

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Diabetes Type 1

Interventions

Type	Name	Description
DEVICE	MiniMed 780G system	The MiniMed™ 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 SmartGuard™ technology. If patient glucose levels are trending high, it gives patient more insulin. Technology is CE marked.

Timeline

• Start date: 2023-09-14
• Primary completion: 2024-09-07
• Completion: 2024-12-31
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: Poland