The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs

  • STATUS
    Recruiting
  • participants needed
    350
  • sponsor
    Universitaire Ziekenhuizen Leuven
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Updated on 16 February 2024
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type 1 diabetes mellitus
diabetes
insulin

Summary

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMedTM 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of this insulin pump on glycemic control and patient-reported outcomes (PROMs) is still unclear. Therefore, this study will evaluate the impact of the Medtronic MiniMedTM 670G system on glycemic control and PROMs in people living with type 1 diabetes under real-life conditions. In a multicenter real-world observational study, 350 people with type 1 diabetes who are treated with the Medtronic MiniMedTM 670G system in one of 17 Belgian centers, will be followed for a period of 12 months. The primary endpoint is the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after start of the Medtronic MiniMedTM 670G system.

Since not much is known about the impact of hybrid closed-loop on partners of adults living with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating the quality of life in partners of type 1 diabetes patients using the Medtronic MiniMedTM 670G system. More specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of the Medtronic MiniMedTM 670G system.

Details
Condition Insulin dependent diabetes mellitus
Age 18years - 100years
Treatment Medtronic MiniMedTM 670G
Clinical Study IdentifierNCT04414280
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

patients with type 1 diabetes
patients aged 18 years or older
patients starting with the Medtronic MiniMedTM 670G system (as part of routine clinical practice) in one of the 17 participating centers. Note: the decision about which patient to start, is left to the clinical judgement of the treating health care professional
patients who signed informed consent

Exclusion Criteria

patients without type 1 diabetes
patients under 18 years of age
patients not starting with the Medtronic MiniMedTM 670G system in one of the 17 participating centers
patients who did not sign informed consent
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