Clinical trial NCT06207838: Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Type 1
Keywords: AHCL
Insulin pump therapy
Multiple daily injection
QoL
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2024-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial is a two-centers, randomized controlled, parallel group study
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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)

Primary outcomes:
measure: 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).
timeFrame: Month 12
Secondary outcomes:
measure: Between groups difference in the percentage of participants achieving TIR >70%
timeFrame: Month 12
measure: Between group difference in the percentage of time spent in hyperglycemic range with SG > 250 mg/dL (13.9 mmol/L)
timeFrame: Month 12
measure: Between group difference in the percentage of time spent in hyperglycemic range with SG > 180 mg/dL (10.0 mmol/L)
timeFrame: Month 12
measure: Between group difference in the percentage of time spent in hypoglycemic range with SG < 54 mg/dL (3.0 mmol/L)
timeFrame: Month 12
measure: Between group difference in the percentage of time spent in hyperglycemic range in hypoglycemic range with SG < 70 mg/dL (3.9 mmol/L)
timeFrame: Month 12
measure: QoL group difference using: The World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: Month 12
measure: Differences in baseline vs end of the study in vascular status as measured with LDF: Laser Doppler Flowmetry
timeFrame: Month 12
measure: Differences in baseline vs end of the study in vascular status as measured with FMD: Flow-Mediated Dilatation
timeFrame: Month 12
measure: Differences in baseline vs end of the study in vascular status as measured with IMT-Intima-media thickness
timeFrame: Month 12
measure: Difference in physical capacity indices listed in screening visit: 6 Minute Walk Test
timeFrame: Month 12
measure: Difference in physical capacity indices listed in screening visit: Fried Scale
timeFrame: Month 12
measure: Difference in physical capacity indices listed in screening visit: Berg Balance Scale
timeFrame: Month 12
measure: Difference in physical capacity indices listed in screening visit: Four Square Step
timeFrame: Month 12
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Hospital University; Jagiellonian University Medical College
Study officials:
affiliation: Jagiellonian University
name: Tomasz Klupa, Prof.
role: PRINCIPAL_INVESTIGATOR
References: