Gestational DiabetesDiP GlucoMoNCT05037526
Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
A study testing Dexcom G System and Self monitoring blood glucose in people with Gestational Diabetes, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Dexcom G System and Self monitoring blood glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Sep 2021to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed Consent as documented by signature
- GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
- Maternal age of 18 to 45 years,
- Singleton gestation
- Gestational age ≥ 24 0/7 weeks and <32 0/7 weeks at enrollment.
Who cannot join
- Known hypersensitivity or allergy to the sensor
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
- Participation in another study with investigational drug or product within the 30 days preceding and during the present study
- Maternal age < 18 years,
- Multi-fetal gestations,
- Known fetal structural or chromosomal anomalies
Show all 12Show fewer
- Chronic use of medications associated with hyperglycemia (steroids)
- Planned preterm delivery
- Overt diabetes mellitus type 1 or 2
- HbA1c by study entry > 6.5%
- History of bariatric surgery or other surgeries that induce malabsorption
- Fetal growth restriction by study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes in Pregnancy Project Und Mobile Health in Gestational Diabetes: An Open Label Randomized Controlled Monocentric Trial on the Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care
Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.
Read the detailed description
The incidence of obesity and diabetes is rising worldwide even in younger populations. With a rise in maternal obesity also gestational diabetes mellitus (GDM) becomes more prevalent with a prevalence of up to 18% of pregnancies. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. The main purpose of this study is to prove that real time continuous glucose monitoring (rt-CGM) can effectively reduce the risk for adverse pregnancy and neonatal outcome in GDM. It is further hypothesized that rt-CGM can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of GDM. This is a open label randomized controlled trial with two parallel groups.
- Conditions
- Gestational Diabetes
- Being tested
- Dexcom G System, Self monitoring blood glucose
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G SystemDevice
Continuous glucose monitoring system
Self monitoring blood glucoseDevice
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G System | Active comparator | The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app. Receives: Device: Dexcom G System |
| Standard care of gestational diabetes with self monitoring blood glucose (SMBG) | Active comparator | SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. Receives: Device: Self monitoring blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse pregnancy and neonatal outcome
The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight >90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.
Measured: 2 years
Secondary outcomes (24)
Initiated Therapy
Need for antiglycemic therapy in example Insulin yes/no
Measured: 10-14 weeks
Glycemic Outcomes 1
Glycemic variability including number and duration of hypoglycemic and hyperglycemic events, mean interstitial glucose in mmol/L and its standard deviation (SD) A hypoglycemic event was defined for two separate analyses as excursions of at least 15 min below the target range (<3.5 mmol/L), and a hyperglycemic event was defined for two separate analyses as excursions of at least 15 min above the target range (>7.8 mmol/L).
Measured: 10-14 weeks
Glycemic Outcomes 2
Time in glucose target in %
Measured: 10-14 weeks
Glycemic Outcomes 3
Duration and frequency postprandial hyperglycaemic excursions
Measured: 10-14 weeks
Glycemic Outcomes 4
Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %
Measured: 10-14 weeks
Pregnancy complications
Pregnancy Complications such as
- Placenta insufficiency (Estimated fetal weight < 10th centile and blood flow changes),
- Gestational hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mg Hg on two occasions at least 4 hours apart)
- Preeclampsia (international Society for the Study of Hypertension in Pregnancy (ISSHP) definition)
Measured: 10-14 weeks
Mode of Delivery
Mode of delivery including cesarean delivery, induction of labor, need for operative vaginal delivery (forceps or vacuum-assisted vaginal delivery)
Measured: 10-14 weeks
Need for induction of labor
Induction of labor yes/no
Measured: 10-14 weeks
Obstetrical outcome
Obstetric injury yes/no
Measured: 10-14 weeks
Maternal outcomes
Body mass index (BMI) (pre-pregnancy and at the time of delivery) weight and height will be combined to report BMI in kg/m^2
Measured: 10-14 weeks
Maternal weight gain
Weight gain after GDM diagnosis in kg
Measured: 10-14 weeks
Maternal Compliance
Adherence to therapy yes/no
Measured: 10-14 weeks
Maternal satisfaction questionnaire
Patient satisfaction after pregnancy evaluated through a questionnaire
Measured: 10-14 weeks
Postpartum disorder
8 weeks postpartum oral glucose test values in mmol/L
Measured: 10-14 weeks
Birth age
Gestational age at delivery in weeks
Measured: 10-14 weeks
Preterm
Preterm delivery (delivery < 37 weeks gestational age) yes/no
Measured: 10-14 weeks
Neonatal weight
Birth weight in grams
Measured: 10-14 weeks
Neonatal outcome
Small for gestational age (birth weight < 10%) yes/no
Measured: 10-14 weeks
Neonatal condition
Poor condition at birth (Apgar score at 5 minutes <7, Arterial pH of <7.0) yes/no
Measured: 10-14 weeks
Neonatal Morbidity
Perinatal morbidity prior to hospital discharge.
Measured: 10-14 weeks
Neonatal birth trauma
Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)
Measured: 10-14 weeks
Resuscitation
Need for resuscitation yes/no
Measured: 10-14 weeks
Neonatal Care
Admission to neonatal intensive care unit (NICU) with length of stay in days
Measured: 10-14 weeks
Respiratory distress syndrome
Respiratory distress syndrome (need for supplemental oxygen > 4 hours after birth) yes/no
Measured: 10-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start24 Sep 2021
- Primary completion31 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofia Amylidi-Mohr, MD, Principal investigator, Uniuversity Hospital and University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037526
- Sponsor's protocol ID
- UCB_GDMV4.0
- Acronym
- DiP GlucoMo
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2021
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castorino K, Polsky S, O'Malley G, Levister C, Nelson K, Farfan C, Brackett S, Puhr S, Levy CJ. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2020 Dec;22(12):943-947. doi: 10.1089/dia.2020.0085.
PubMed 32324061Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
PubMed 28724718Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.
PubMed 28923465Inayama Y, Yamanoi K, Shitanaka S, Ogura J, Ohara T, Sakai M, Suzuki H, Kishimoto I, Tsunenari T, Suginami K. A novel classification of glucose profile in pregnancy based on continuous glucose monitoring data. J Obstet Gynaecol Res. 2021 Apr;47(4):1281-1291. doi: 10.1111/jog.14677. Epub 2021 Jan 27.
PubMed 33501738Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study. PLoS One. 2020 Apr 16;15(4):e0230476. doi: 10.1371/journal.pone.0230476. eCollection 2020.
PubMed 32298269Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
PubMed 31177185Amylidi-Mohr S, Zennaro G, Schneider S, Raio L, Mosimann B, Surbek D. Continuous glucose monitoring in the management of gestational diabetes in Switzerland (DipGluMo): an open-label, single-centre, randomised, controlled trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):591-599. doi: 10.1016/S2213-8587(25)00063-4. Epub 2025 May 26.
PubMed 40441173
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes in Pregnancy Project Und Mobile Health in Gestational Diabetes: An Open Label Randomized Controlled Monocentric Trial on the Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care
- ClinicalTrials.gov ID
- NCT05037526
- Acronym / sponsor ID
- DiP GlucoMo / UCB_GDMV4.0
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 8 Sep 2021 (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.
Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.
Detailed description
The incidence of obesity and diabetes is rising worldwide even in younger populations. With a rise in maternal obesity also gestational diabetes mellitus (GDM) becomes more prevalent with a prevalence of up to 18% of pregnancies. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. The main purpose of this study is to prove that real time continuous glucose monitoring (rt-CGM) can effectively reduce the risk for adverse pregnancy and neonatal outcome in GDM. It is further hypothesized that rt-CGM can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of GDM. This is a open label randomized controlled trial with two parallel groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexcom G System | Active comparator | Device: Dexcom G SystemThe Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app. |
| Standard care of gestational diabetes with self monitoring blood glucose (SMBG) | Active comparator | Device: Self monitoring blood glucoseSMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature
- GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
- Maternal age of 18 to 45 years,
- Singleton gestation
- Gestational age ≥ 24 0/7 weeks and <32 0/7 weeks at enrollment.
Key exclusion criteria (12 listed)
- Known hypersensitivity or allergy to the sensor
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
- Participation in another study with investigational drug or product within the 30 days preceding and during the present study
- Maternal age < 18 years,
- Multi-fetal gestations,
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 |
|---|---|---|
| Dexcom G SystemContinuous glucose monitoring system | Device | Dexcom G System |
| Self monitoring blood glucoseStandard Care | Device | Standard care of gestational diabetes with self monitoring blood glucose (SMBG) |
Primary outcome
Composite adverse pregnancy and neonatal outcome
Time frame: 2 years
The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight >90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.
24 secondary outcomes
Initiated Therapy
Time frame: 10-14 weeks
Glycemic Outcomes 1
Time frame: 10-14 weeks
Glycemic Outcomes 2
Time frame: 10-14 weeks
Glycemic Outcomes 3
Time frame: 10-14 weeks
Glycemic Outcomes 4
Time frame: 10-14 weeks
Pregnancy complications
Time frame: 10-14 weeks
Mode of Delivery
Time frame: 10-14 weeks
Need for induction of labor
Time frame: 10-14 weeks
Obstetrical outcome
Time frame: 10-14 weeks
Maternal outcomes
Time frame: 10-14 weeks
Maternal weight gain
Time frame: 10-14 weeks
Maternal Compliance
Time frame: 10-14 weeks
Maternal satisfaction questionnaire
Time frame: 10-14 weeks
Postpartum disorder
Time frame: 10-14 weeks
Birth age
Time frame: 10-14 weeks
Preterm
Time frame: 10-14 weeks
Neonatal weight
Time frame: 10-14 weeks
Neonatal outcome
Time frame: 10-14 weeks
Neonatal condition
Time frame: 10-14 weeks
Neonatal Morbidity
Time frame: 10-14 weeks
Neonatal birth trauma
Time frame: 10-14 weeks
Resuscitation
Time frame: 10-14 weeks
Neonatal Care
Time frame: 10-14 weeks
Respiratory distress syndrome
Time frame: 10-14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Results publication: PubMed 32324061Castorino K, Polsky S, O'Malley G, Levister C, Nelson K, Farfan C, Brackett S, Puhr S, Levy CJ. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2020 Dec;22(12):943-947. doi: 10.1089/dia.2020.0085.
- Results publication: PubMed 28724718Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.
- Results publication: PubMed 28923465Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.
- Results publication: PubMed 33501738Inayama Y, Yamanoi K, Shitanaka S, Ogura J, Ohara T, Sakai M, Suzuki H, Kishimoto I, Tsunenari T, Suginami K. A novel classification of glucose profile in pregnancy based on continuous glucose monitoring data. J Obstet Gynaecol Res. 2021 Apr;47(4):1281-1291. doi: 10.1111/jog.14677. Epub 2021 Jan 27.
- Results publication: PubMed 32298269Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study. PLoS One. 2020 Apr 16;15(4):e0230476. doi: 10.1371/journal.pone.0230476. eCollection 2020.
- Results publication: PubMed 31177185Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
- Derived from this study: PubMed 40441173Amylidi-Mohr S, Zennaro G, Schneider S, Raio L, Mosimann B, Surbek D. Continuous glucose monitoring in the management of gestational diabetes in Switzerland (DipGluMo): an open-label, single-centre, randomised, controlled trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):591-599. doi: 10.1016/S2213-8587(25)00063-4. Epub 2025 May 26.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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. This study is not recruiting at the moment.
Sofia Amylidi-Mohr, MD principal investigator
Uniuversity Hospital and University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G System and Self monitoring blood glucose in people with Gestational Diabetes, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 16 Dec 2024. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite adverse pregnancy and neonatal outcome (time frame: 2 years). 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 NCT05037526, which also lists 7 linked publications.
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 16 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.