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Closed-Loop Insulin in Mothers With Type 1 Diabetes and Baby Feeding Practices

NCT04420728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-23

No results posted yet for this study

Summary

This study will is a parallel two-group randomized controlled trial that will use the MiniMed 670G hybrid closed-loop system's continuous glucose monitor (GCM) insulin pump and computer algorithm to deliver insulin when in "auto mode". This study will be conducted in women with type 1 diabetes after delivery of their neonate to see if "auto-mode" improves blood sugar control, episodes of low blood sugar, burden of diabetes self-care, alters baby's weight and feeding patterns, and partner diabetes distress.

Conditions

  • Diabetes Mellitus Type 1 Pre-Existing
  • Pregnancy Related
  • Feeding Behavior
  • Infant Development

Interventions

COMBINATION_PRODUCT

Early auto-mode

Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.

COMBINATION_PRODUCT

Delayed auto mode

Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.

Sponsors & Collaborators

  • Calgary Health Trust

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • Ward of the 21st Century

    collaborator OTHER

  • University of Calgary

    lead OTHER

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
2020-07-15
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04420728 on ClinicalTrials.gov