Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes

Summary

Multi-centric open-label randomized controlled trial (RCT) with 11 Belgian centers and one Dutch center in pregnant women with type 1 diabetes to assess safety, efficacy, feasibility and cost-effectiveness of 780 MiniMed Medtronic hybrid closed-loop insulin system (intervention group) compared to standard of care therapy (control group).

Conditions

• Type1 Diabetes

Interventions

DEVICE

780G

780G closed-loop insulin delivery system (Medtronic)

DEVICE

standard of care

continue with standard of care treatment (pump without closed-loop or MDI)

Sponsors & Collaborators

• University Hospital, Ghent

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Imelda Hospital, Bonheiden

  collaborator OTHER

• AZ Sint-Jan AV

  collaborator OTHER

• AZ Delta

  collaborator OTHER

• Onze Lieve Vrouw Hospital

  collaborator OTHER

• General Hospital Groeninge

  collaborator OTHER

• AZ Nikolaas

  collaborator OTHER

• AZ Turnhout

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Katrien Benhalima, MD PhD · UZ Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-15

Primary Completion

2023-04-30

Completion

2023-05-10

Countries

• Belgium
• Netherlands

Study Locations