GDMDiGESTnewbornNCT04192422
DiGESTnewborn Study
An observational study of GDM and Hypoglycemia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GDM, Hypoglycemia
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mothers and their babies who have been enrolled in DiGest Trial a trial of dietary intervention in women with gestational diabetes
Who may be able to join
- mothers and their babies who have been enrolled in DiGest Trial and who have provided informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrookes Hospital
Cambridge, Cambridge
Kathryn Beardsall, FRCPCH, 00441223 746791, kb274@medschl.cam.ac.uk
Kathryn Beardsall, FRCPCH
About this study
Official title: 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.
- Conditions
- GDM, Hypoglycemia
- Being tested
- no intervention
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is a cohort study no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal sensor glucose time in target
Time sensor glucose levels in target in the first week of life
Measured: From sensor insertion for up to the first 7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Sep 2020
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192422
- Sponsor's protocol ID
- DiGestnewborn v2.0 24.10.2019
- Acronym
- DiGESTnewborn
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2019
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Control and Metabolic Adaptation in Offspring of Women With Gestational Diabetes Recruited to the DiGest Study
- ClinicalTrials.gov ID
- NCT04192422
- Acronym / sponsor ID
- DiGESTnewborn / DiGestnewborn v2.0 24.10.2019
- Conditions
- GDM, Hypoglycemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers and their babies who have been enrolled in DiGest Trial a trial of dietary intervention in women with gestational diabetes
Key inclusion criteria (1 listed)
- mothers and their babies who have been enrolled in DiGest Trial and who have provided informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis is a cohort study no intervention | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GDM and Hypoglycemia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kathryn beardsall (07565964631, kb274@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal sensor glucose time in target (time frame: From sensor insertion for up to the first 7 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.