Type 2 DiabetesNCT06903728
National Trial of CGM in Pregnant Women With Type 2 Diabetes
A study testing continous glucose monitoring in people with Type 2 Diabetes and Pregnancy, run by Odense University Hospital.
Trial summary
The goal of this clinical trial is to evaluate the use of glucose sensors in pregnant women with type 2 diabetes to improve insulin regulation, pregnancy and birth outcomes, and enhance quality of life and satisfaction with treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 2 Diabetes, Pregnancy
- What is being tested?
- continous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2026
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women with type 2 diabetes
- attending one of the four centers for pregnancy and diabetes in Denmark
- 18 years old or above
Who cannot join
- gestationel age 14+0 or above
- ekspected birth after end of trial
- already using a continous glucose monitor (sensor)
About this study
Official title: National forsøgsordning Med Glukosesensorer Til Type 2-diabetes: Glukosesensorer Til Gravide Med Type 2-diabetes
The goal of this clinical trial is to evaluate the use of glucose sensors in pregnant women with type 2 diabetes to improve insulin regulation, pregnancy and birth outcomes, and enhance quality of life and satisfaction with treatment.
The main questions it aims to answer are:
Read more
- Does the use of glucose sensors during pregnancy lead to a clinically significant reduction in HbA1c by 0.3% at 36 weeks gestation compared to the control group?
- Does the use of glucose sensors during pregnancy result in a clinically significant reduction in mean SD-score for birth weight deviation in newborns compared to the control group?
Researchers will compare the group of women using glucose sensors during pregnancy to a historical control group receiving routine care to see if the sensor improves pregnancy outcomes, glucose control, and birth weights.
Participants will:
- Use a glucose sensor from before 14 weeks of pregnancy until 4-6 weeks postpartum.
- Receive training on how to use the sensor and access ongoing support as needed.
- Have a follow-up appointment 4-6 weeks postpartum, including a consultation for advice on medical treatment and further management of diabetes after birth.
- Conditions
- Type 2 Diabetes, Pregnancy
- Being tested
- continous glucose monitoring
- Keywords
- CGM in type 2 diabetes, CGM in pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continous glucose monitoringDevice
Pregnant women with type 2 diabetes are given a sensor < week 14 of their pregnancy and will use it until 4-6 post partum. They will receive training in how to use the sensor, and support when needed.
| Study group | Role | What they receive |
|---|---|---|
| Sensor use | Experimental | Participants are given a sensor to use during pregnancy until 4-6 weeks post partum Receives: Device: continous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at end of pregnancy (week 36 of pregnancy)
Measured: baseline < week 14 of pregnancy, follow up week 36 of pregnancy
child birth weight SD-score
Measured: at time of birth
Secondary outcomes (13)
TIR, TAR, TBR
Percentage of time in time in range, time above range and time below range during their pregnancy.
Measured: from enrollment to 4-6 weeks post partum
Mean glucose
Sensor specific data
Measured: from enrollment to 4-6 weeks post partum
Womens gestational wheight gain
weight gain during throughout pregnancy
Measured: from enrollment to birth
Hypoglykemia among newborn
Hypoglykemia among newborn
Measured: at time of birth
Pregnancy related complications
increased blood pressure and preeclampsia
Measured: from enrollment to birth
Birth related complications
c-section, early birth
Measured: at time of birth
Problem Areas in Diabetes (PAID)
Diabetes stress
Measured: Baseline, week 28, 4-6 weeks post partum
World Health Organisation - Five Well-Being Index (WHO-5)
quality of life
Measured: Baseline, week 28, 4-6 weeks post partum
12-Item Short-Form (SF12)
Health status
Measured: Baseline, week 28, 4-6 weeks post partum
Patient Assessment of Cronic Illness Care (PACIC)
Satisfaction with care
Measured: Baseline, week 28, 4-6 weeks post partum
Glucose Monitoring Satisfaction Survey (GMSS)
Satisfaction with method used for glucose measuring
Measured: Baseline, week 28, 4-6 weeks post partum
Pregnancy Physical Activity Questionnaire (PPAQ-DK
Physical activity in pregnancy
Measured: Baseline, week 28
Diet items from the National Danish Birth Cohort
Pregnancy specific questions related to diet
Measured: Baseline, week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Steno Diabetes Center Copenhagen, Aarhus University Hospital, Steno Diabetes Center Nordjylland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903728
- Sponsor's protocol ID
- CGM til gravide med T2D
- Status last verified
- Jul 2025
- First submitted
- 25 Mar 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National forsøgsordning Med Glukosesensorer Til Type 2-diabetes: Glukosesensorer Til Gravide Med Type 2-diabetes
- ClinicalTrials.gov ID
- NCT06903728
- Acronym / sponsor ID
- CGM til gravide med T2D
- Conditions
- Type 2 Diabetes, Pregnancy
- Keywords
- CGM in type 2 diabetes, CGM in pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Steno Diabetes Center Copenhagen, Aarhus University Hospital, Steno Diabetes Center Nordjylland
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Apr 2025 (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.
The goal of this clinical trial is to evaluate the use of glucose sensors in pregnant women with type 2 diabetes to improve insulin regulation, pregnancy and birth outcomes, and enhance quality of life and satisfaction with treatment.
The main questions it aims to answer are:
- Does the use of glucose sensors during pregnancy lead to a clinically significant reduction in HbA1c by 0.3% at 36 weeks gestation compared to the control group?
- Does the use of glucose sensors during pregnancy result in a clinically significant reduction in mean SD-score for birth weight deviation in newborns compared to the control group?
Researchers will compare the group of women using glucose sensors during pregnancy to a historical control group receiving routine care to see if the sensor improves pregnancy outcomes, glucose control, and birth weights.
Participants will:
- Use a glucose sensor from before 14 weeks of pregnancy until 4-6 weeks postpartum.
- Receive training on how to use the sensor and access ongoing support as needed.
- Have a follow-up appointment 4-6 weeks postpartum, including a consultation for advice on medical treatment and further management of diabetes after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensor use | Experimental | Device: continous glucose monitoringParticipants are given a sensor to use during pregnancy until 4-6 weeks post partum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pregnant women with type 2 diabetes
- attending one of the four centers for pregnancy and diabetes in Denmark
- 18 years old or above
Key exclusion criteria (3 listed)
- gestationel age 14+0 or above
- ekspected birth after end of trial
- already using a continous glucose monitor (sensor)
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 |
|---|---|---|
| continous glucose monitoringPregnant women with type 2 diabetes are given a sensor < week 14 of their pregnancy and will use it until 4-6 post partum. They will receive training in how to use the sensor, and support when needed. | Device | Sensor use |
Primary outcome
HbA1c at end of pregnancy (week 36 of pregnancy)
Time frame: baseline < week 14 of pregnancy, follow up week 36 of pregnancy
child birth weight SD-score
Time frame: at time of birth
13 secondary outcomes
TIR, TAR, TBR
Time frame: from enrollment to 4-6 weeks post partum
Mean glucose
Time frame: from enrollment to 4-6 weeks post partum
Womens gestational wheight gain
Time frame: from enrollment to birth
Hypoglykemia among newborn
Time frame: at time of birth
Pregnancy related complications
Time frame: from enrollment to birth
Birth related complications
Time frame: at time of birth
Problem Areas in Diabetes (PAID)
Time frame: Baseline, week 28, 4-6 weeks post partum
World Health Organisation - Five Well-Being Index (WHO-5)
Time frame: Baseline, week 28, 4-6 weeks post partum
12-Item Short-Form (SF12)
Time frame: Baseline, week 28, 4-6 weeks post partum
Patient Assessment of Cronic Illness Care (PACIC)
Time frame: Baseline, week 28, 4-6 weeks post partum
Glucose Monitoring Satisfaction Survey (GMSS)
Time frame: Baseline, week 28, 4-6 weeks post partum
Pregnancy Physical Activity Questionnaire (PPAQ-DK
Time frame: Baseline, week 28
Diet items from the National Danish Birth Cohort
Time frame: Baseline, week 28
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 31 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing continous glucose monitoring in people with Type 2 Diabetes and Pregnancy, run by Odense University Hospital.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c at end of pregnancy (week 36 of pregnancy) (time frame: baseline < week 14 of pregnancy, follow up week 36 of pregnancy). The study lists 2 primary outcomes in all. 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 31 Jul 2025.