Diabetes, GestationalNCT06291766
Gestational Diabetes After Gastric Bypass Surgery
A study testing FreeStyle Libre 2, continous glucose monitoring in people with Diabetes, Gestational and Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery. The main question it aims to answer is: How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diabetes, Gestational, Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium, Pregnancy in Diabetic
- What is being tested?
- FreeStyle Libre 2, continous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2024to Dec 2035
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Understands written and spoken Swedish
- Previous Gastric Bypass surgery
- Diagnosed with gestational diabetes according to our local criteria
- Planned follow up at the Specialized Maternity Ward at Skane University Hospital
- Understands the use of CGM and is willing to use the system
- Have signed informed consent
Who cannot join
- Other kinds of bariatric surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Region Skane
Lund, 221 85
Ulrika Moll, MD, PhD
About this study
Official title: The Impact of Continous Glucose Monitoring on Pregnancy Outcome, in Women With Gestational Diabetes and a History of Gastric Bypass Surgery.
The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery.
The main question it aims to answer is:
How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women.
Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups.
Read the detailed description
The project aims to investigate gestational diabetes in women with a history of gastric bypass surgery (GBP). The investigators will analyse glucose levels by using continuous glucose measurement (GCM) or capillary glucose measurements and compare mean glucose values, treatment and the pregnancy outcome.
In Sweden the incidence of gestational diabetes is 2-5% of pregnancies, but the frequency varies greatly in different areas and in different ethnicities. The women with gestational diabetes have an increased risk of complications during pregnancy. The most acknowledged complications are large for gestational age infants (LGA), preeclampsia and caesarean section. The infants have a higher need for neonatal intensive care, due to the risk of hypoglycaemia, hypoxia and jaundice postpartum. Treating gestational diabetes and normalizing glucose values have been proven to reduce risks of unfavourable pregnancy outcome.
Gastric bypass surgery is a common treatment for obesity. The frequency of young women with gastric bypass surgery and concomitant gestational diabetes have increased. Many maternity care centres have started to use a 3-7 day screening for gestational diabetes, since the routine oral glucose toleration test (OGTT) is not recommended after GBP. It is previously shown that women with GBP have a decreased risk of GDM and LGA infants. However, there is an increased risk of small for gestational age (SGA). There is a lack of knowledge and guidelines regarding the optimal treatment of gestational diabetes in these women. How the glucose variability affects pregnancy outcome is poorly investigated. At Lund University Hospital, Region Skane, Sweden, the screening procedure used since 2012 for GDM-screening in women with GBP is a 3 day 7-point capillary glucose measurement. Approximately 25% of the pregnant women with GBP is diagnosed with GDM, using this method at Lund University Hospital.
In this project the investigators will randomize women with gestational diabetes and a history of gastric bypass (GDM-GBP) into two different groups in the last trimester of pregnancy. Both groups are given standard medical care, which includes visits to the Specialized Maternity Care Unit and weekly follow up by the diabetologist. The first group is given continuous glucose measurement (FreeStyle Libre3) and the other group is given standard medical care which includes 7-point capillary glucose measurement. With the CGM system it is possible to collect more comprehensive data regarding glucose values and variability. Previous studies have shown that women with gastric bypass surgery have an earlier than normal postprandial glucose excursion and are more prone to later postprandial hypoglycaemia. During this study, the physician as well as the patient can observe the early glucose excursion after meals and measure time in target, time above target and time below target. Large for gestational age and accelerated growth of the infant is supposed to be due to high glucose values and a high proportion of Time above target. The increased risk of SGA infants in these women is hypothesized to be due to a large proportion of time below target. However, this theory is not sufficiently investigated and it is not known if the use of CGM can help to reduce the risk of weight deviation in the infants.
The investigators want to examine if new technique in glucose measurement can contribute to more favourable pregnancy outcome in women with gestational diabetes and a history of GDM. The main question is if the use of CGM affect pregnancy outcome. The secondary outcomes includes glucose variability and the use of different treatment approaches in GDM in this group of women.
- Conditions
- Diabetes, Gestational, Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium, Pregnancy in Diabetic, Blood Glucose Self Monitoring
- Being tested
- FreeStyle Libre 2, continous glucose monitoring
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre 2, continous glucose monitoringDevice
The use of FreeStyle Libre 3 sensors and Libre Link app and Glooko app for analysing glucose control in pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Continous glucose measurement | Other | Use of FreeStyle Libre 3, with Libre Link app and Glooko app for measurement and review of glucose measurements. Receives: Device: FreeStyle Libre 2, continous glucose monitoring |
| Capillary glucose measurement | No intervention | Standard care, including capillary glucose measurements and Glooko app for review of glucose measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Pregnancy Outcome
ANY: Caesarian section (Y/N), instrumental delivery (Y/N), preeclampsia (Y/N), premature birth before week 37 (Y/N), Macrosomia (>4000g) (Y/N), Large for gestational age infant (Y/N), small for gestational age infant (Y/N), shoulder dystocia (Y/N), neonatal hypoglycemia (Y/N) (<4 hours after birth: <1.4 mmol/L; 4 to <24 hours after birth: <1.9 mmol/L; 24 to <48 hours after birth: <2.8 mmol/L, ≥48 hours after birth: 3.3 mmol/L
Measured: During delivery and postpartum (measured up to 5 days postpartum)
Secondary outcomes (11)
Glucose values
Mean/median glucose values (mmol/l)
Measured: Gestational week 28-42
Glucose values
Glucose variability (SD)
Measured: Gestational week 28-42
Glucose values
% Time in Target (3,5-7,8 mmol/l)
Measured: Gestational week 28-42
Glucose values
% Time below target
Measured: Gestational week 28-42
Glucose values
% Time above target
Measured: Gestational week 28-42
Pharmacological treatment
The use of insulin (Y/N)
Measured: Gestational week 28-42
Pharmacological treatment
the dose of insulin (IE)
Measured: Gestational week 28-42
Pharmacological treatment
the use of Metformin (Y/N)
Measured: Gestational week 28-42
Pharmacological treatment
the dose of metformin (g/day)
Measured: Gestational week 28-42
Birthweight
birth weight of infant (g)
Measured: at the day of birth
Week of delivery
gestational week
Measured: exact day (ie 28+0 to 42+6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrika Moll, Region Skane
- Investigators
- Ulrika Moll, MD, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291766
- Sponsor's protocol ID
- 2022-05498-01
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moll U, Landin-Olsson M, Nilsson C, Ursing D, Strevens H. Pregnancy outcome in women with gestational diabetes - A longitudinal study of changes in demography and treatment modalities. Acta Obstet Gynecol Scand. 2020 Mar;99(3):333-340. doi: 10.1111/aogs.13758. Epub 2019 Dec 22.
PubMed 31654523
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Continous Glucose Monitoring on Pregnancy Outcome, in Women With Gestational Diabetes and a History of Gastric Bypass Surgery.
- ClinicalTrials.gov ID
- NCT06291766
- Acronym / sponsor ID
- 2022-05498-01
- Conditions
- Diabetes, Gestational, Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium, Pregnancy in Diabetic, Blood Glucose Self Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 4 Mar 2024 (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 trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery.
The main question it aims to answer is:
How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women.
Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups.
Detailed description
The project aims to investigate gestational diabetes in women with a history of gastric bypass surgery (GBP). The investigators will analyse glucose levels by using continuous glucose measurement (GCM) or capillary glucose measurements and compare mean glucose values, treatment and the pregnancy outcome.
In Sweden the incidence of gestational diabetes is 2-5% of pregnancies, but the frequency varies greatly in different areas and in different ethnicities. The women with gestational diabetes have an increased risk of complications during pregnancy. The most acknowledged complications are large for gestational age infants (LGA), preeclampsia and caesarean section. The infants have a higher need for neonatal intensive care, due to the risk of hypoglycaemia, hypoxia and jaundice postpartum. Treating gestational diabetes and normalizing glucose values have been proven to reduce risks of unfavourable pregnancy outcome.
Gastric bypass surgery is a common treatment for obesity. The frequency of young women with gastric bypass surgery and concomitant gestational diabetes have increased. Many maternity care centres have started to use a 3-7 day screening for gestational diabetes, since the routine oral glucose toleration test (OGTT) is not recommended after GBP. It is previously shown that women with GBP have a decreased risk of GDM and LGA infants. However, there is an increased risk of small for gestational age (SGA). There is a lack of knowledge and guidelines regarding the optimal treatment of gestational diabetes in these women. How the glucose variability affects pregnancy outcome is poorly investigated. At Lund University Hospital, Region Skane, Sweden, the screening procedure used since 2012 for GDM-screening in women with GBP is a 3 day 7-point capillary glucose measurement. Approximately 25% of the pregnant women with GBP is diagnosed with GDM, using this method at Lund University Hospital.
In this project the investigators will randomize women with gestational diabetes and a history of gastric bypass (GDM-GBP) into two different groups in the last trimester of pregnancy. Both groups are given standard medical care, which includes visits to the Specialized Maternity Care Unit and weekly follow up by the diabetologist. The first group is given continuous glucose measurement (FreeStyle Libre3) and the other group is given standard medical care which includes 7-point capillary glucose measurement. With the CGM system it is possible to collect more comprehensive data regarding glucose values and variability. Previous studies have shown that women with gastric bypass surgery have an earlier than normal postprandial glucose excursion and are more prone to later postprandial hypoglycaemia. During this study, the physician as well as the patient can observe the early glucose excursion after meals and measure time in target, time above target and time below target. Large for gestational age and accelerated growth of the infant is supposed to be due to high glucose values and a high proportion of Time above target. The increased risk of SGA infants in these women is hypothesized to be due to a large proportion of time below target. However, this theory is not sufficiently investigated and it is not known if the use of CGM can help to reduce the risk of weight deviation in the infants.
The investigators want to examine if new technique in glucose measurement can contribute to more favourable pregnancy outcome in women with gestational diabetes and a history of GDM. The main question is if the use of CGM affect pregnancy outcome. The secondary outcomes includes glucose variability and the use of different treatment approaches in GDM in this group of women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous glucose measurement | Other | Device: FreeStyle Libre 2, continous glucose monitoringUse of FreeStyle Libre 3, with Libre Link app and Glooko app for measurement and review of glucose measurements. |
| Capillary glucose measurement | No intervention | –Standard care, including capillary glucose measurements and Glooko app for review of glucose measurements. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understands written and spoken Swedish
- Previous Gastric Bypass surgery
- Diagnosed with gestational diabetes according to our local criteria
- Planned follow up at the Specialized Maternity Ward at Skane University Hospital
- Understands the use of CGM and is willing to use the system
Key exclusion criteria (1 listed)
- Other kinds of bariatric surgery
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 |
|---|---|---|
| FreeStyle Libre 2, continous glucose monitoringThe use of FreeStyle Libre 3 sensors and Libre Link app and Glooko app for analysing glucose control in pregnancy | Device | Continous glucose measurement |
Primary outcome
Adverse Pregnancy Outcome
Time frame: During delivery and postpartum (measured up to 5 days postpartum)
ANY: Caesarian section (Y/N), instrumental delivery (Y/N), preeclampsia (Y/N), premature birth before week 37 (Y/N), Macrosomia (>4000g) (Y/N), Large for gestational age infant (Y/N), small for gestational age infant (Y/N), shoulder dystocia (Y/N), neonatal hypoglycemia (Y/N) (<4 hours after birth: <1.4 mmol/L; 4 to <24 hours after birth: <1.9 mmol/L; 24 to <48 hours after birth: <2.8 mmol/L, ≥48 hours after birth: 3.3 mmol/L
11 secondary outcomes
Glucose values
Time frame: Gestational week 28-42
Glucose values
Time frame: Gestational week 28-42
Glucose values
Time frame: Gestational week 28-42
Glucose values
Time frame: Gestational week 28-42
Glucose values
Time frame: Gestational week 28-42
Pharmacological treatment
Time frame: Gestational week 28-42
Pharmacological treatment
Time frame: Gestational week 28-42
Pharmacological treatment
Time frame: Gestational week 28-42
Pharmacological treatment
Time frame: Gestational week 28-42
Birthweight
Time frame: at the day of birth
Week of delivery
Time frame: exact day (ie 28+0 to 42+6)
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 22 Aug 2025.
- Background: PubMed 31654523Moll U, Landin-Olsson M, Nilsson C, Ursing D, Strevens H. Pregnancy outcome in women with gestational diabetes - A longitudinal study of changes in demography and treatment modalities. Acta Obstet Gynecol Scand. 2020 Mar;99(3):333-340. doi: 10.1111/aogs.13758. Epub 2019 Dec 22.
- 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.
Ulrika Moll, MD, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre 2, continous glucose monitoring in people with Diabetes, Gestational and Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium, run by Region Skane at 1 site in Sweden.
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 6 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 22 Aug 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 Sweden. 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 Ulrika Moll, MD, PhD (+46733307170, ulrika.moll@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Pregnancy Outcome (time frame: During delivery and postpartum (measured up to 5 days postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291766, which also lists 1 linked publication.
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 22 Aug 2025.