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

Universitaire Ziekenhuizen KU Leuven

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Medtronic MiniMed 670G; Device: Medtronic MiniMed 780G; Device: Tandem Control-IQ

Study type: Observational

Funder types: Other

Identifiers

NCT04414280

S63351

Details and patient eligibility

About

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 these new kinds of insulin pumps on glycemic control and patient-reported outcomes (PROMs) is still unclear. Therefore, this study will evaluate the impact of the Medtronic MiniMed 670G, Medtronic MiniMed 780G and Tandem Control-IQ systems on glycemic control and PROMs in people living with type 1 diabetes under real-life conditions. In a multicenter real-world observational study, 350 adults and 100 children with type 1 diabetes who are treated with each of these systems in one of 17 Belgian centers, will be followed for a period of 24 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 hybrid closed-loop therapy.

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 adults of type 1 diabetes using hybrid closed-loop therapy. More specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of hybrid closed-loop therapy.

Enrollment: 1,150 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

1,150 participants in 3 patient groups

type 1 diabetes patients using Medtronic MiniMed 670G

Description:

Patients with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 670G system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.

Treatment:

Device: Medtronic MiniMed 670G

type 1 diabetes patients using Medtronic MiniMed 780G

Description:

Patients with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 780G system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.

Treatment:

Device: Medtronic MiniMed 780G

type 1 diabetes patients using Tandem Control-IQ

Description:

Patients with type 1 diabetes, aged 6 years or older, who start with the Tandem Control-IQ system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.

Treatment:

Device: Tandem Control-IQ