Gestational Diabetes Mellitus (GDM)NCT07685015
The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus
A study testing Myo-inositol 2 g + Folic acid 200 µg, Folic acid 200 µg and Insulin therapy in people with Gestational Diabetes Mellitus (GDM), run by Medical University of Vienna at 2 sites in Austria.
Trial summary
The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Myo-inositol 2 g + Folic acid 200 µg, Folic acid 200 µg and Insulin therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesAustria
- Study dates
- 23 Mar 2026to 1 Jul 2027
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- GDM diagnosis
- at least one of the HAPO-Study criteria: 2h-oGTT → >153 mg/dl, 1h-oGGT → >180 mg/dl, fasting plasma glucose > 92 mg/dl
- age between 18-45
- single pregnancy
Who cannot join
- T2DM
- T1DM
- Maturity Onset Diabetes of the Young (MODY)
- Latent Autoimmune Diabetes in Adults (LADA)
- pre pregnancy BMI >35
- oral antidiabetic drugs
Show all 9Show fewer
- pre-existing renal disease
- heart disease and other chronic medical disorders
- allergies to any ingredients contained in the dietary supplements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc contact
Austria2 sites, 2 recruiting
- Recruiting
Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna
Vienna, State of Vienna, 1090
Ricarda Rosalia Baron Baron, MSc, + 43 40400 20690, Ricarda.Baron@meduniwien.ac.at
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc, +43 1 404 00-60950, Michael.Leutner@meduniwien.ac.at
Ricarda Rosalia Baron, MSc, MSc
About this study
Official title: The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study
The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM).
The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery.
Read more
The intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments.
Blood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these periods.
Three study visits are planned, during which the following assessments will be conducted. To determine the primary outcome, "time in range (TIR)" (time spent within the target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed.
Additionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Myo-inositol 2 g + Folic acid 200 µg, Folic acid 200 µg, Insulin therapy, Nutrition therapy
- Keywords
- Gestational Diabetes Mellitus, GDM, Myo-Inositol, Continous Glucose Monitoring, CGM, Oxidative Stress, Inflammation, Glycemic Control, Inositol, MYO, MI, Pregnancy
- Medical subject headings
- Diabetes, Gestational, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositol 2 g + Folic acid 200 µgDietary supplement
This dietary supplement contains 2 g of myo-inositol and 200 µg folic acid per capsule. It should be taken twice a day (à 3 capsules) with fluid intake and a meal.
Folic acid 200 µgDietary supplement
This dietary supplement contains 200 μg of folic acid per capsule and should also be taken twice a day (à 1 capsule) with adequate fluid intake and a main meal.
Insulin therapyDrug
Women with GDM who maintain their blood glucose levels with insulin therapy.
Nutrition therapyBehavioural
Women with GDM who maintain their blood sugar levels with nutritional therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1. Intervention group (nutrition therapy + myo-inositol + folic acid) | Experimental | Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the investigational supplement myo-inositol plus folic acid. Receives: Dietary Supplement: Myo-inositol 2 g + Folic acid 200 µg; Behavioral: Nutrition therapy |
| 2. Intervention group (insulin therapy + myo-inositol + folic acid) | Experimental | Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the investigational supplement myo-inositol plus folic acid. Receives: Dietary Supplement: Myo-inositol 2 g + Folic acid 200 µg; Drug: Insulin therapy |
| 3. Control group (nutrition therapy + folic acid) | Active comparator | Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid. Receives: Dietary Supplement: Folic acid 200 µg; Behavioral: Nutrition therapy |
| 4. Control group (inuslin therapy + folic acid) | Active comparator | Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid. Receives: Dietary Supplement: Folic acid 200 µg; Drug: Insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Time in Range [%] measured with continous glucose monitoring
Measured: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37
Secondary outcomes (28)
Fasting glucose
fasting glucose [mg/dl] concentration
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Fasting insulin
fasting insulin [μIU/mL] concentration
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
HOMA-IR
HOMA-IR calculated as fasting insulin level (micro-units per milliliter) multiplied by the fasting blood glucose level (milligrams per deciliter), dividing the result by 405
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
HbA1c
HbA1c [%] concentration
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Insulin doses
insulin units [IU]
Measured: from day 1 until delivery
Pre Pregnancy BMI
weight [kg]/height [m]^2
Measured: before pregnancy
Height in meters
height [m]
Measured: at baseline
Weight in kilograms
weight [kg]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Blood Pressure
blood pressure [mmHg]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
C-Section (maternal and fetal outcomes)
C-Section yes or no
Measured: at delivery
Hypoglycemia of the child (maternal and fetal outcomes)
glucose values of the child [mg/dl]
Measured: at delivery
Preterm birth (maternal and fetal outcomes)
delivery before 37. gestational week yes or no
Measured: at delivery
Gestational weight of the child (maternal and fetal outcomes)
gestational weight of the child [kg]
Measured: at delivery
Oxidative stress parameter
total antioxidative capacity [µmol/l]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Oxidative stress parameter
Malondialdehy status [µmol/l]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
C-reactive protein [mg/dl]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
interleucin-6 [pg/ml]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Psychometric parameter
Questionnaire: Pregnancy-related Anxiety score
- minimum score: 10
- maximum score: 50
Measured: 24.-28. gestational week, 37. gestational week
Psychometric parameter
Questionnaire: Postnatal-Depression score
- total possible score: 0-30
- higher scores: more depressive symptoms
Measured: 24.-28. gestational week, 37. gestational week
Psychometric parameter
Questionnaire: Perceived Stress score
- minimum raw score: 20
- maximum raw score: 80
Measured: 24.-28. gestational week, 37. gestational week
Physical Activity parameter
Questionnaire: Physical Activity score [MET]
- average daily energy expenditure by calculating the metabolic equivalents (METs) for each activity
Measured: 24.-28. gestational week, 37. gestational week
Nutritional log
Food diary for 10 days
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
fat mass [kg]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
total body water [%]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
muscle mass [kg]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
fat free mass [%]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
body cell mass [%]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
extracellular mass [%]
Measured: 24.-28. gestational week, 33. gestational week, 37. gestational week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start23 Mar 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a single-center, open-label, randomized, controlled pilot study. The investigators aim to enroll 40 women with GDM, randomly allocated to one of the 4 groups. The interventions groups are divided in group 1 (nutrition therapy + myo-inositol + folic acid) and group 2 (insulin therapy + myo-inositol + folic acid). The control groups are separated in group 3 (nutrition therapy + folic acid) and group 4 (insulin therapy + folic acid).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- BIOGENA GmbH, Salzburg
- Responsible party
- Principal investigator, Michael Leutner, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685015
- Sponsor's protocol ID
- 2469/2024
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2025
- Last updated
- 6 Jul 2026
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study
- ClinicalTrials.gov ID
- NCT07685015
- Acronym / sponsor ID
- 2469/2024
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes Mellitus, GDM, Myo-Inositol, Continous Glucose Monitoring, CGM, Oxidative Stress, Inflammation, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- BIOGENA GmbH, Salzburg
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Jul 2026 (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 purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM).
The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery.
The intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments.
Blood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these periods.
Three study visits are planned, during which the following assessments will be conducted. To determine the primary outcome, "time in range (TIR)" (time spent within the target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed.
Additionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is designed as a single-center, open-label, randomized, controlled pilot study. The investigators aim to enroll 40 women with GDM, randomly allocated to one of the 4 groups. The interventions groups are divided in group 1 (nutrition therapy + myo-inositol + folic acid) and group 2 (insulin therapy + myo-inositol + folic acid). The control groups are separated in group 3 (nutrition therapy + folic acid) and group 4 (insulin therapy + folic acid).
| Arm | Type | Receives |
|---|---|---|
| 1. Intervention group (nutrition therapy + myo-inositol + folic acid) | Experimental | Dietary Supplement: Myo-inositol 2 g + Folic acid 200 µg, Behavioral: Nutrition therapyWomen who maintain their blood glucose levels within the normal range through nutritional therapy and receive the investigational supplement myo-inositol plus folic acid. |
| 2. Intervention group (insulin therapy + myo-inositol + folic acid) | Experimental | Dietary Supplement: Myo-inositol 2 g + Folic acid 200 µg, Drug: Insulin therapyWomen who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the investigational supplement myo-inositol plus folic acid. |
| 3. Control group (nutrition therapy + folic acid) | Active comparator | Dietary Supplement: Folic acid 200 µg, Behavioral: Nutrition therapyWomen who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid. |
| 4. Control group (inuslin therapy + folic acid) | Active comparator | Dietary Supplement: Folic acid 200 µg, Drug: Insulin therapyWomen who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- GDM diagnosis
- at least one of the HAPO-Study criteria: 2h-oGTT → >153 mg/dl, 1h-oGGT → >180 mg/dl, fasting plasma glucose > 92 mg/dl
- age between 18-45
- single pregnancy
Key exclusion criteria (9 listed)
- T2DM
- T1DM
- Maturity Onset Diabetes of the Young (MODY)
- Latent Autoimmune Diabetes in Adults (LADA)
- pre pregnancy BMI >35
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 |
|---|---|---|
| Myo-inositol 2 g + Folic acid 200 µgThis dietary supplement contains 2 g of myo-inositol and 200 µg folic acid per capsule. It should be taken twice a day (à 3 capsules) with fluid intake and a meal. | Dietary supplement | 1. Intervention group (nutrition therapy + myo-inositol + folic acid), 2. Intervention group (insulin therapy + myo-inositol + folic acid) |
| Folic acid 200 µgThis dietary supplement contains 200 μg of folic acid per capsule and should also be taken twice a day (à 1 capsule) with adequate fluid intake and a main meal. | Dietary supplement | 3. Control group (nutrition therapy + folic acid), 4. Control group (inuslin therapy + folic acid) |
| Insulin therapyWomen with GDM who maintain their blood glucose levels with insulin therapy. | Drug | 2. Intervention group (insulin therapy + myo-inositol + folic acid), 4. Control group (inuslin therapy + folic acid) |
| Nutrition therapyWomen with GDM who maintain their blood sugar levels with nutritional therapy. | Behavioural | 1. Intervention group (nutrition therapy + myo-inositol + folic acid), 3. Control group (nutrition therapy + folic acid) |
Primary outcome
Time in Range
Time frame: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37
Time in Range [%] measured with continous glucose monitoring
28 secondary outcomes
Fasting glucose
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Fasting insulin
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
HOMA-IR
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
HbA1c
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Insulin doses
Time frame: from day 1 until delivery
Pre Pregnancy BMI
Time frame: before pregnancy
Height in meters
Time frame: at baseline
Weight in kilograms
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Blood Pressure
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
C-Section (maternal and fetal outcomes)
Time frame: at delivery
Hypoglycemia of the child (maternal and fetal outcomes)
Time frame: at delivery
Preterm birth (maternal and fetal outcomes)
Time frame: at delivery
Gestational weight of the child (maternal and fetal outcomes)
Time frame: at delivery
Oxidative stress parameter
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Oxidative stress parameter
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Inflammatory parameter
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Psychometric parameter
Time frame: 24.-28. gestational week, 37. gestational week
Psychometric parameter
Time frame: 24.-28. gestational week, 37. gestational week
Psychometric parameter
Time frame: 24.-28. gestational week, 37. gestational week
Physical Activity parameter
Time frame: 24.-28. gestational week, 37. gestational week
Nutritional log
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
Bioelectrical Impedance Analysis (BIA)
Time frame: 24.-28. gestational week, 33. gestational week, 37. gestational week
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 6 Jul 2026.
- 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.
Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo-inositol 2 g + Folic acid 200 µg, Folic acid 200 µg and Insulin therapy in people with Gestational Diabetes Mellitus (GDM), run by Medical University of Vienna at 2 sites in Austria.
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 4 inclusion and 9 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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 Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc (+43 1 404 00-60950, michael.leutner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (time frame: 10 days at baseline (24.-28. gestational week), 10 days into gestational week 33, 10 days into gestational week 36/37). 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 6 Jul 2026.