Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump (780G65+)

Jagiellonian University

Status: Invitation-only

Conditions: Diabetes Type 1

Treatments: Device: MiniMed 780G system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06207838

1072.61201.5.2023

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age over 65 years
2. T1DM
3. Willing to participate in a study for the specified duration
4. Willing to perform ≥ 4 finger stick blood glucose measurements daily
5. Willing to wear the system continuously throughout the study
6. Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
7. Treated with MDI/CSII (with exclusion of 780G)
8. Willing to perform at least 4 BGM/day, when on MDI/CSII
9. Lack of advanced complications of diabetes, eGFR>30

Exclusion criteria

1. Severe concurrent illness
2. Laboratory abnormalities, or medications that might affect study participation,
3. Severe renal impairment (eGFR<30)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Actual therapy

No Intervention group

Description:

The patient continues Multiple Daily Injection/Insulin Pump Therapy with or without CGM use as per routine procedures

Advanced Hybrid Cloosed Loop System

Experimental group

Description:

The patients will be switched to MiniMed 780G advanced hybrid cloosed loop system/ AHCL system

Treatment:

Device: MiniMed 780G system