Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Universitaire Ziekenhuizen KU Leuven

Conditions:

Diabetes Mellitus, Type 1

Eligibility:

All Genders

6+ years

Brief Summary

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of th...

Eligibility Criteria

Inclusion

  • patients with type 1 diabetes
  • patients aged 6 years or older
  • patients starting with hybrid closed-loop therapy (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

  • patients without type 1 diabetes
  • patients under 6 years of age
  • patients not starting with hybrid closed-loop therapy in one of the 17 participating centers
  • patients who did not sign informed consent

Key Trial Info

Start Date :

March 12 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

1150 Patients enrolled

Trial Details

Trial ID

NCT04414280

Start Date

March 12 2020

End Date

December 31 2025

Last Update

March 17 2025

Active Locations (18)

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Page 1 of 5 (18 locations)

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

2

OLVZ Aalst

Aalst, Belgium, 9300

3

GZA Ziekenhuizen - campus Sint-Vincentius

Antwerp, Belgium, 2018

4

Hôpital d'Arlon

Arlon, Belgium, 6700

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