NCT04192422

Brief Summary

We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Sep 2020Dec 2026

First Submitted

Initial submission to the registry

November 29, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

6.2 years

First QC Date

November 29, 2019

Last Update Submit

April 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neonatal sensor glucose time in target

    Time sensor glucose levels in target in the first week of life

    From sensor insertion for up to the first 7 days of life

Interventions

This is a cohort study no intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mothers and their babies who have been enrolled in DiGest Trial a trial of dietary intervention in women with gestational diabetes

You may qualify if:

  • mothers and their babies who have been enrolled in DiGest Trial and who have provided informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrookes Hospital

Cambridge, Cambridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

kathryn beardsall

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 10, 2019

Study Start

September 1, 2020

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations