Can a smartphone program and glucose monitor reduce heart risks after gestational diabetes?
NCT ID NCT06648174
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether a lifestyle program delivered through a mobile app, combined with a continuous glucose monitor (Abbott FreeStyle Libre 2), can improve blood sugar control and reduce cardiometabolic risk in 120 pregnant women diagnosed with gestational diabetes. Participants wear the glucose monitor during pregnancy and receive personalized feedback. The goal is to see if this approach leads to better health outcomes for both mother and baby.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Continuous glucose monitor (Abbott FreeStyle Libre 2) and a lifestyle intervention based on the health belief model, delivered via mobile health
- What this could lead to
- If successful, this approach could help women with gestational diabetes better control their blood sugar and reduce long-term heart and metabolic risks.
- What could go wrong
- This is a small, early-stage study (120 participants) testing a behavioral intervention, so results may not apply broadly. The lifestyle program requires active participation, and the glucose monitor may cause skin irritation in some users.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or above 2. Pregnant women diagnosed with gestational diabetes mellitus 3. Willing to participate in the study Exclusion Criteria: 1. Diagnosed with diabetes mellitus before pregnancy 2. Allergic to materials such as tapes (e.g., redness, swelling, itching, pain, blisters, or rashes caused by breathable tapes or patches) 3. Abnormal coagulation function
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
RECRUITINGHsinchu, 302058, Taiwan
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Other studies related to the condition(s) this trial covers.
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