- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192422
DiGESTnewborn Study (DiGESTnewborn)
January 11, 2021 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
Study Type
Observational
Enrollment (Anticipated)
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
- Name: kathryn beardsall
- Phone Number: 07565964631
- Email: kb274@cam.ac.uk
Study Locations
-
-
-
Cambridge, United Kingdom
- Recruiting
- Addenbrookes Hospital
-
Contact:
- Kathryn Beardsall, FRCPCH
- Phone Number: 00441223 746791
- Email: kb274@medschl.cam.ac.uk
-
Principal Investigator:
- 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
Genders Eligible for Study
All
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.
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 (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2025
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)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiGestnewborn v2.0 24.10.2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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