Status:
ENROLLING_BY_INVITATION
Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump
Lead Sponsor:
Jagiellonian University
Collaborating Sponsors:
Medtronic
Conditions:
Diabetes Type 1
Eligibility:
All Genders
65+ years
Phase:
NA
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 s...
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 insuli...
Eligibility Criteria
Inclusion
- Age over 65 years
- T1DM
- Willing to participate in a study for the specified duration
- Willing to perform ≥ 4 finger stick blood glucose measurements daily
- Willing to wear the system continuously throughout the study
- Glycosylated hemoglobin (A1C) value less than 10.0% at time of screening visit
- Treated with MDI/CSII (with exclusion of 780G)
- Willing to perform at least 4 BGM/day, when on MDI/CSII
- Lack of advanced complications of diabetes, eGFR\>30
Exclusion
- Severe concurrent illness
- Laboratory abnormalities, or medications that might affect study participation,
- Severe renal impairment (eGFR\<30)
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06207838
Start Date
September 14 2023
End Date
December 31 2024
Last Update
January 17 2024
Active Locations (1)
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1
Hospital University; Jagiellonian University Medical College
Krakow, Poland, 30688