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

NCT04520971 | Completed

• 1 other identifier: S64308
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 12

Brief 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

Keywords

closed-loop insulin delivery

Outcome Measures

Primary Outcomes (1)

• time in range

  time between 63-140mg/dl (pregnancy glycemic target range)

  from 14 weeks to 36 weeks

Secondary Outcomes (57)

• time in range during the night

  from 14 weeks to 36 weeks

• time below low day and night

  from 14 weeks to 36 weeks

• overnight time low

  from 14 weeks to 36 weeks

• time in range during the day

  from 14 weeks to 36 weeks

• time in range early pregnancy

  from 9 weeks to 12 weeks

Study Arms (2)

780G closed-loop

EXPERIMENTAL

780 closed-loop insulin delivery system

Device: 780G

standard of care

ACTIVE COMPARATOR

standard of care treatment (continue with current treatment of insulin pump without closed-loop or multiple daily insulin injections).

Device: standard of care

Interventions

780G DEVICE

780G closed-loop insulin delivery system (Medtronic)

780G closed-loop

standard of care DEVICE

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

standard of care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with type 1 diabetes (T1DM), diagnosed with T1DM at least 1 year before pregnancy
• Age 18-45 years
• A singleton pregnancy confirmed by b-HCG in blood and/or ultrasound-confirmed gestational age up to 11 weeks and 6 days.
• Treated with intensive insulin treatment (either MDI or insulin pump). A closed-loop system can only be used in manual mode.
• Have a booking HbA1c (measurement taken at the first antenatal clinic visit after confirmed pregnancy) level ≤10%.
• Participants need to speak and understand Flemish, French or English and have e-mail access.

You may not qualify if:

• The use of a closed-loop insulin delivery system in auto mode.
• A twin (multiple) pregnancy
• A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician)
• Medications known to interfere with glucose metabolism
• An insulin dose of ≥1.5 units/kg
• Known allergy to adhesives due to infusion set and/or CGM

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University Hospital, Ghent: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• University Hospital, Antwerp: collaborator
• Imelda Hospital, Bonheiden: collaborator
• AZ Sint-Jan AV: collaborator
• AZ Delta: collaborator
• Onze Lieve Vrouw Hospital: collaborator
• General Hospital Groeninge: collaborator
• AZ Nikolaas: collaborator
• AZ Turnhout: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• Amsterdam UMC: collaborator

Study Sites (12)

OLV Aalst-Asse

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

Imelda Bonheiden

Bonheiden, 2820, Belgium

Location

AZ St Jan Brugge

Bruges, 8000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

UCLouvain

Brussels, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Groeninge Kortrijk

Kortrijk, 8510, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

AZ Roeselare

Roeselare, 8800, Belgium

Location

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Related Publications (2)

• Beunen K, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, Nobels F, Marlier J, Lee D, Cuypers J, Preumont V, Siegelaar SE, Painter RC, Laenen A, Gillard P, Mathieu C, Benhalima K. Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial - study protocol. BMC Pregnancy Childbirth. 2023 Mar 16;23(1):180. doi: 10.1186/s12884-023-05481-0.

  PMID: 36927458 BACKGROUND

• Benhalima K, Beunen K, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, Nobels F, Marlier J, Lee D, Cuypers J, Preumont V, Siegelaar SE, Painter RC, Laenen A, Gillard P, Mathieu C. Comparing advanced hybrid closed loop therapy and standard insulin therapy in pregnant women with type 1 diabetes (CRISTAL): a parallel-group, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2024 Jun;12(6):390-403. doi: 10.1016/S2213-8587(24)00089-5. Epub 2024 Apr 30.

  PMID: 38697182 RESULT

Study Officials

• Katrien Benhalima, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1/1 randomization to 780G or continue with standard of care

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: January 15, 2021
• Primary Completion: April 30, 2023
• Study Completion: May 10, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

BE (11); NL (1)