Type 1 Diabetes
Conditions
Brief summary
Automated insulin delivery systems, also known as closed-loop systems, have shown to improve TIR, TAR, and TBR compared with insulin pump and CGM systems that cannot automatically dose insulin. Only few studies have described long-term use of AID systems over several years. Real-world studies suggest that the beneficial effects of AID systems on glycemic outcomes are sustained over time; however, a modest increase in body weight has been observed in some users, raising concerns about the metabolic trade-offs of improved glycemia. We aim to explore wether the improvements in glycemic outcomes and treatment satisfaction achieved with AID systems remain stable over multiple years, and secondly, if long-term treatment with AID systems may be associated with an increase in body weight.
Detailed description
40 participants, who have completed the Steno780G trial, will be invited to attend a follow-up visit at Steno Diabetes Center Copenhagen between 3.5 - 4.5 years after start of AID treatment to assess the long-term effects of the MiniMed 780G system.
Interventions
DEVICE780G AID pump
Long term follow-up
Sponsors
Steno Diabetes Center Copenhagen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous participation in the Steno780G study
Exclusion criteria
* Lack of compliance with key study procedures at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in range | Last 2 weeks compared with 2 weeks before 780G start |
Secondary
| Measure | Time frame |
|---|---|
| Time above and below range | Last 2 weeks compared with 2 weeks before 780G start |
| HbA1c | Compared with HbA1c before 780G |
| Body weight | Compared with bodyweight before 780G start |
| Mean sensor glucose | Last 2 weeks compared with 2 weeks before 780G start |
| Glycemic variability | last 2 weeks compared with 2 weeks before 780G start |
| Diabetes treatment satisfaction score | compared with DTQS before 780G start |
| Hypoglycaemia Fear Survey scores | Compared with before 780G start |
| Diabetes Distress Scale scores | compared with before 780G start |
Countries
Denmark
Contacts
CONTACTMerete Christensen, MD, PhD
Outcome results
None listed