Gestational Diabetes Mellitus (GDM)IRISNCT07231341
Insulin Resistance in Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus (GDM), run by University of Aarhus at 2 sites in Denmark.
Trial summary
This prospective cohort study investigates glycaemic variability, assessed by continuous glucose monitoring (CGM), in pregnant women with gestational diabetes mellitus (GDM) and its association with fetal growth and related maternal and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 22 Sep 2022to Apr 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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
Study population: Stated in eligibility criteria. According to in- and exculsion criteria the study population will be singleton pregnant women > 18 years of age, with gestational diabetes mellitus (GDM) between gestational age (GA) 28+0 and 34+6, without poorly controlled chronic diseases who are non-smokers and not treated with systemic corticosteroids.
Who may be able to join
- All singleton pregnant women with gestational diabetes mellitus (GDM) between gestational age (GA) 28+0 and 34+6 attending the obstetric outpatient clinic at Aarhus University Hospital, Aarhus, Denmark or Gødstrup Hospital, Herning, Denmark will be offered participation.
Who cannot join
- Pre-gestational diabetes
- Age < 18 years
- Multiple pregnancies
- Chronic disease that is not well-controlled and is expected to influence study outcomes (including inflammatory diseases such as rheumatologic, gastroenterological, etc.)
- Treatment with systemic corticosteroids
- Smoking
- Women who are unable to understand the oral and written patient information
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Ninna L Larsen, MD, 0045 26533336, nll@clin.au.dk
- Recruiting
Gødstrup Hospital
Herning, 7400
Ninna L Larsen, MD, 0045 26533336, nll@clin.au.dk
About this study
This prospective cohort study investigates glycaemic variability, assessed by continuous glucose monitoring (CGM), in pregnant women with gestational diabetes mellitus (GDM) and its association with fetal growth and related maternal and neonatal outcomes. Participants will undergo 14 days of CGM during pregnancy to characterise individual glycaemic patterns. Clinical and paraclinical data, including fasting plasma glucose, HbA1c, lipid profile, organ markers of pregnancy-related medical conditions, maternal weight gain, and blood pressure will be collected at two study visits. Oral glucose tolerance test (OGTT) 2-hour values will be obtained at diagnosis. All participants will receive standard GDM care and routine obstetric follow-up for assessment of fetal growth and wellbeing. Birth weight, birth weight z-scores, and relevant neonatal outcomes will be recorded after delivery.
Statistical analyses will be performed using Stata statistical software (StataCorp LLC, College Station, TX, USA). Continuous and categorical variables will be summarised using appropriate descriptive statistics. Associations between maternal glycaemic variability and neonatal as well as other maternal metabolic outcomes will be explored using suitable statistical methods, with adjustment for relevant covariates. Exploratory analyses may include additional glycaemic variability metrics and lipid parameters to further characterise maternal metabolic patterns.
Read the detailed description
The aim of this prospective cohort study is to investigate glycaemic variability, assessed by continuous glucose monitoring (CGM), in pregnant women with gestational diabetes mellitus (GDM), and its association with fetal growth and related maternal and neonatal outcomes.
Participants will undergo CGM for 14 consecutive days during pregnancy to characterise individual patterns of glycaemic variability. Relevant clinical and paraclinical parameters, including fasting plasma glucose, HbA1c, lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides), organ markers of pregnancy-related medical conditions (including liver and renal function parameters), maternal weight gain, and blood pressure will be recorded at both the commencement and after completion of the monitoring period. Oral glucose tolerance test (OGTT) 2-hour values will be retrieved from the diagnostic visit.
All participants will receive standard clinical care for GDM, including dietary counselling and routine obstetric follow-up for assessment of fetal growth and wellbeing. Following delivery, clinically relevant maternal and neonatal data, including birth weight, birth weight z-scores, and information on pregnancy or neonatal complications, will be obtained from electronic medical records.
Statistical analysis plan
Continuous variables will be assessed for distributional characteristics and summarised using appropriate descriptive statistics. Categorical variables will be presented as frequencies and percentages.
Associations between maternal glycaemic variability indices and study outcomes - including neonatal birth weight z-scores and other secondary maternal and neonatal parameters (e.g., 2-hour OGTT values, HbA1c, fasting glucose, and neonatal hypoglycaemia) will be explored using appropriate statistical methods according to data type and distribution. Multivariable models may be applied to adjust for relevant maternal and pregnancy-related covariates, including maternal age, pre-pregnancy BMI, gestational age at delivery, parity, HbA1c, and other relevant covariates where applicable.
Comparisons of glycaemic and metabolic parameters between relevant subgroups will be conducted using suitable statistical techniques selected based on data characteristics and study objectives. Categorical outcomes will be analysed using appropriate methods for comparison of proportions.
Additional glycaemic variability metrics (SD, MAGE, CONGA, and J-index) will be considered as pre-specified exploratory outcomes and may be analysed, contingent on data completeness and scientific relevance, to further characterise maternal glycaemic patterns. Exploratory analyses of associations between maternal glycaemic variability and lipid parameters (total, HDL, and LDL cholesterol, and triglycerides) may likewise be conducted on a non-primary, hypothesis-generating basis. Lipid measures may also be included as covariates in multivariable models evaluating neonatal outcomes.
All analyses will be two-tailed, and statistical significance will generally be inferred at p < 0.05. Statistical analyses will be performed using Stata statistical software (StataCorp LLC, College Station, TX, USA; current version at time of analysis).
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- GDM, Gestational diabetes mellitus, CGM, Continuous glucose monitoring, Pregnancy, Diabetes in pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women diagnosed with gestational diabetes mellitus | Continuous glucose monitoring for 14 days during pregnancy in women diagnosed with gestational diabetes mellitus. Delivery data are recorded, thus participants are followed up to 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight z-scores
Calculated using reference standards adjusted for gestational age and sex. Unit of measure: z-score (SD units).
Measured: Recorded immediately after delivery.
Secondary outcomes (9)
Maternal glycaemic variability, Coefficient of Variation (CV)
Coefficient of variation (%) of interstitial glucose derived from 14 consecutive days of continuous glucose monitoring (CGM).
Measured: Measurements will be commenced between gestational week 28+0 and 34+6.
Maternal Time in Range (TIR)
Percentage of time with blood glucose levels within the pregnancy target range (3.9 - 7.0 mmol/l) during the 14-day CGM period.
Measured: Measurements will be commenced between gestational week 28+0 and 34+6.
Maternal Time Above Range (TAR)
Percentage of time with blood glucose levels above the pregnancy target range (3.9 - 7.0 mmol/l) during the 14-day CGM period.
Measured: Measurements will be commenced between gestational week 28+0 and 34+6.
Maternal Time Below Range (TBR)
Percentage of time with blood glucose levels below the pregnancy target range (3.9 - 7.0 mmol/l) during the 14-day CGM period.
Measured: Measurements will be commenced between gestational week 28+0 and 34+6.
2-hour oral glucose tolerance test (OGTT)
2-hour venous plasma glucose following a 75-g oral glucose tolerance test performed during routine GDM screening. Unit of measure: mmol/L.
Measured: Measured at diagnosis of gestational diabetes mellitus.
HbA1c
Maternal HbA1c levels (mmol/mol, IFCC).
Measured: Maternal HbA1c levels measured at first study visit (gestational week 28+0 to 34+6) and at the second study visit (gestational week 30+0 to birth).
Fasting blood glucose
Fasting venous plasma glucose (mmol/L).
Measured: Measured at first study visit (gestational week 28+0 to 34+6) and after completion of the measurement period, at the second study visit (gestational week 30+0 to birth).
Neonatal hypoglycaemia
Neonatal blood glucose <2.5 mmol/l.
Measured: From birth to 24 hours of life.
Birth weight
Absolute neonatal birth weight measured after delivery (grams).
Measured: Immediately after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start22 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (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 University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Ninna Lund Larsen, University of Aarhus
- Investigators
- Ninna L Larsen, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231341
- Sponsor's protocol ID
- 1-10-72-350-21
- Acronym
- IRIS
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 17 Nov 2025
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07231341
- Acronym / sponsor ID
- IRIS / 1-10-72-350-21
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- GDM, Gestational diabetes mellitus, CGM, Continuous glucose monitoring, Pregnancy, Diabetes in pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 17 Nov 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.
This prospective cohort study investigates glycaemic variability, assessed by continuous glucose monitoring (CGM), in pregnant women with gestational diabetes mellitus (GDM) and its association with fetal growth and related maternal and neonatal outcomes. Participants will undergo 14 days of CGM during pregnancy to characterise individual glycaemic patterns. Clinical and paraclinical data, including fasting plasma glucose, HbA1c, lipid profile, organ markers of pregnancy-related medical conditions, maternal weight gain, and blood pressure will be collected at two study visits. Oral glucose tolerance test (OGTT) 2-hour values will be obtained at diagnosis. All participants will receive standard GDM care and routine obstetric follow-up for assessment of fetal growth and wellbeing. Birth weight, birth weight z-scores, and relevant neonatal outcomes will be recorded after delivery.
Statistical analyses will be performed using Stata statistical software (StataCorp LLC, College Station, TX, USA). Continuous and categorical variables will be summarised using appropriate descriptive statistics. Associations between maternal glycaemic variability and neonatal as well as other maternal metabolic outcomes will be explored using suitable statistical methods, with adjustment for relevant covariates. Exploratory analyses may include additional glycaemic variability metrics and lipid parameters to further characterise maternal metabolic patterns.
Detailed description
The aim of this prospective cohort study is to investigate glycaemic variability, assessed by continuous glucose monitoring (CGM), in pregnant women with gestational diabetes mellitus (GDM), and its association with fetal growth and related maternal and neonatal outcomes.
Participants will undergo CGM for 14 consecutive days during pregnancy to characterise individual patterns of glycaemic variability. Relevant clinical and paraclinical parameters, including fasting plasma glucose, HbA1c, lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides), organ markers of pregnancy-related medical conditions (including liver and renal function parameters), maternal weight gain, and blood pressure will be recorded at both the commencement and after completion of the monitoring period. Oral glucose tolerance test (OGTT) 2-hour values will be retrieved from the diagnostic visit.
All participants will receive standard clinical care for GDM, including dietary counselling and routine obstetric follow-up for assessment of fetal growth and wellbeing. Following delivery, clinically relevant maternal and neonatal data, including birth weight, birth weight z-scores, and information on pregnancy or neonatal complications, will be obtained from electronic medical records.
Statistical analysis plan
Continuous variables will be assessed for distributional characteristics and summarised using appropriate descriptive statistics. Categorical variables will be presented as frequencies and percentages.
Associations between maternal glycaemic variability indices and study outcomes - including neonatal birth weight z-scores and other secondary maternal and neonatal parameters (e.g., 2-hour OGTT values, HbA1c, fasting glucose, and neonatal hypoglycaemia) will be explored using appropriate statistical methods according to data type and distribution. Multivariable models may be applied to adjust for relevant maternal and pregnancy-related covariates, including maternal age, pre-pregnancy BMI, gestational age at delivery, parity, HbA1c, and other relevant covariates where applicable.
Comparisons of glycaemic and metabolic parameters between relevant subgroups will be conducted using suitable statistical techniques selected based on data characteristics and study objectives. Categorical outcomes will be analysed using appropriate methods for comparison of proportions.
Additional glycaemic variability metrics (SD, MAGE, CONGA, and J-index) will be considered as pre-specified exploratory outcomes and may be analysed, contingent on data completeness and scientific relevance, to further characterise maternal glycaemic patterns. Exploratory analyses of associations between maternal glycaemic variability and lipid parameters (total, HDL, and LDL cholesterol, and triglycerides) may likewise be conducted on a non-primary, hypothesis-generating basis. Lipid measures may also be included as covariates in multivariable models evaluating neonatal outcomes.
All analyses will be two-tailed, and statistical significance will generally be inferred at p < 0.05. Statistical analyses will be performed using Stata statistical software (StataCorp LLC, College Station, TX, USA; current version at time of analysis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women diagnosed with gestational diabetes mellitus | – | –Continuous glucose monitoring for 14 days during pregnancy in women diagnosed with gestational diabetes mellitus. Delivery data are recorded, thus participants are followed up to 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stated in eligibility criteria. According to in- and exculsion criteria the study population will be singleton pregnant women > 18 years of age, with gestational diabetes mellitus (GDM) between gestational age (GA) 28+0 and 34+6, without poorly controlled chronic diseases who are non-smokers and not treated with systemic corticosteroids.
Key inclusion criteria (1 listed)
- All singleton pregnant women with gestational diabetes mellitus (GDM) between gestational age (GA) 28+0 and 34+6 attending the obstetric outpatient clinic at Aarhus University Hospital, Aarhus, Denmark or Gødstrup Hospital, Herning, Denmark will be offered participation.
Key exclusion criteria (7 listed)
- Pre-gestational diabetes
- Age < 18 years
- Multiple pregnancies
- Chronic disease that is not well-controlled and is expected to influence study outcomes (including inflammatory diseases such as rheumatologic, gastroenterological, etc.)
- Treatment with systemic corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Birth weight z-scores
Time frame: Recorded immediately after delivery.
Calculated using reference standards adjusted for gestational age and sex. Unit of measure: z-score (SD units).
9 secondary outcomes
Maternal glycaemic variability, Coefficient of Variation (CV)
Time frame: Measurements will be commenced between gestational week 28+0 and 34+6.
Maternal Time in Range (TIR)
Time frame: Measurements will be commenced between gestational week 28+0 and 34+6.
Maternal Time Above Range (TAR)
Time frame: Measurements will be commenced between gestational week 28+0 and 34+6.
Maternal Time Below Range (TBR)
Time frame: Measurements will be commenced between gestational week 28+0 and 34+6.
2-hour oral glucose tolerance test (OGTT)
Time frame: Measured at diagnosis of gestational diabetes mellitus.
HbA1c
Time frame: Maternal HbA1c levels measured at first study visit (gestational week 28+0 to 34+6) and at the second study visit (gestational week 30+0 to birth).
Fasting blood glucose
Time frame: Measured at first study visit (gestational week 28+0 to 34+6) and after completion of the measurement period, at the second study visit (gestational week 30+0 to birth).
Neonatal hypoglycaemia
Time frame: From birth to 24 hours of life.
Birth weight
Time frame: Immediately after delivery.
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 17 Nov 2025.
- 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.
Ninna L Larsen, MD principal investigator
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus (GDM), run by University of Aarhus at 2 sites in Denmark.
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 1 inclusion and 7 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 17 Nov 2025. 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 Denmark. 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 Ninna L Larsen, MD (0045 26533336, nll@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight z-scores (time frame: Recorded immediately after delivery.). 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 17 Nov 2025.