DiGESTnewborn Study (DiGESTnewborn)

April 15, 2025 updated by: Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust

Glucose Control and Metabolic Adaptation in Offspring of Women With Gestational Diabetes Recruited to the DiGest Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Recruiting
        • Addenbrookes Hospital
        • Contact:
        • Contact:
          • Kathryn Beardsall, FRCPCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal sensor glucose time in target
Time Frame: From sensor insertion for up to the first 7 days of life
Time sensor glucose levels in target in the first week of life
From sensor insertion for up to the first 7 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

December 8, 2019

First Posted (Actual)

December 10, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiGestnewborn v2.0 24.10.2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoglycemia

Clinical Trials on no intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe