Gestational Diabetes MellitusFLAMINGONCT04422821
Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial
A study testing Flash Glucose Monitoring and Self-Monitoring of Blood Glucose in people with Gestational Diabetes Mellitus, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Gestational diabetes mellitus (GDM) is glucose intolerance diagnosed for the first time in pregnancy. According to literature GDM affects 3-10% of pregnant women and is a risk factor for multiple maternal and fetal complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Flash Glucose Monitoring and Self-Monitoring of Blood Glucose
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2020to 10 Nov 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- singleton pregnancy between 24-28 weeks of gestation
- gestational diabetes mellitus diagnosis
Who cannot join
- multiple pregnancy
- fetal malformations
- pre-gestational diabetes mellitus
- chronic or pregnancy-induced hypertension
- chronic renal or hepatic disease, in-vitro fertilization
- delivery <37 weeks of gestation
Show all 11Show fewer
- pre-mature rupture of membranes
- placenta previa
- stillbirth
- smoking in pregnancy
- intake of medications including: methyldopa, tetracyclin, acetylosalicylic acid, acetaminofen, ibuprofen, L-dopa, tolazamide, tolbutamide
Trial locations and contacts
1 site in 1 country.
Poland1 site
1st Department of Obstetrics and Gynecology, Medical University of Warsaw
Warsaw, Starynkiewicza Sq. 1/3, 02-015
About this study
Gestational diabetes mellitus (GDM) is glucose intolerance diagnosed for the first time in pregnancy. According to literature GDM affects 3-10% of pregnant women and is a risk factor for multiple maternal and fetal complications. During pregnancy GDM significantly increases the risk of fetal macrosomia, shoulder dystocia, birth trauma and Cesarean section. Furthermore, the long-term complications of GDM include increased risk of development of diabetes mellitus type 2 in the mother, as well as increased risk of obesity, diabetes and metabolic syndrome occurrence in their children. It has been well-documented that the risk of above-mentioned complications increases with the level of maternal hyperglycemia.
Proper glycemia control is one of the key elements in the effective treatment of GDM. Until recently, glucose monitoring was solely performed using glucose meters, which required multiple fingerpricks. Nowadays, due to the glycemia monitoring systems development, such as flash glucose monitoring (FGM), glucose levels may be measured less invasively through subcutaneous sensor application. As shown in one of the studies, FGM due to the ease of use, was 3 times more often applied as a method of glycemia control than SMBG. As a result, patients from FGM group had significantly better blood glucose control.
The main purpose of our study is to evaluate the impact of new method of glycemia control (FGM) on the efficacy of treatment of GDM. By analyzing results of this study, such as mean glycemia levels, number of women requiring insulin therapy and maternal-fetal perinatal outcomes the investigators will provide a scientific basis for more common use of FGM in the population of pregnant women affected by GDM.
Read the detailed description
This is a randomized controlled trial performed at the 1st Department of Obstetrics and Gynecology of Medical University of Warsaw. The study will recruit 100 women at 24-28 weeks of gestation . Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomized to Flash Glucose Monitoring (n=50) or Self-Monitoring of Blood Glucose (n=50) group.
The study group will obtain instruction for using Freestyle Libre app to measure and collect glycemia results using a mobile phone.
The control group will be informed about proper use of glucose meters.
All participants will be obliged to measure fasting and 1-h postprandial glucose concentrations in a daily manner, together with once per week midnight measurement.
All participants will obtain dietary recommendations for gestational diabetes mellitus and recommendations about daily physical activity in pregnancy.
In order to assess daily physical activity all participants will obtain a wristband allowing for footsteps measurement.
An evaluation of patient's dietary habits will be based on Eating Assessment Test prepared by the Polish National Institute of Public Health - National Institute of Hygiene.
Clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy.
After delivery, at the follow-up visit research staff will retrieve maternal and neonatal outcomes from patients medical history.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Flash Glucose Monitoring, Self-Monitoring of Blood Glucose
- Keywords
- gestational diabetes mellitus, flash glucose monitoring, glycemia
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flash Glucose MonitoringDevice
Also called FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA)
Flash Glucose Monitoring FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA) sensor placed subcutaneously that will be applied for 14 days, then removed and changed for the second sensor for the next 14 days.
Self-Monitoring of Blood GlucoseDevice
Also called iXell®; Genexo sp; Warsaw, Poland
Self-Monitoring of Blood Glucose with a standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) performed through a skin-puncturing 4 times a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Libre™ | Experimental | FreeStyle Libre™ will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will receive subcutaneous sensor for glucose monitoring (FreeStyle Libre™; Abbott Diabetes Care, Alameda, CA) for 4 weeks. Receives: Device: Flash Glucose Monitoring |
| iXell® | Active comparator | iXell® will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will monitor glycemia through use of standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) for 4 weeks. Receives: Device: Self-Monitoring of Blood Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean glycemia results (fasting and 1-h postprandial glucose concentrations)
Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus.
Measured: 28 days after the recruitment visit
Secondary outcomes (9)
Number of patients requiring insulin therapy
Number of patients in each group requiring insulin therapy will by analyzed at the second, third and fourth follow-up visit.
Measured: 2, 4 and 8 weeks after the recruitment visit
Long-term glycemic control using blood HbA1c serum concentration
Difference in HbA1c serum concentration in each group will by analyzed at the third and fourth follow-up visit.
Measured: 4 and 8 weeks after the recruitment visit
Number of hypoglycemia episodes (glucose concentration <70 mg/dl) during one month analysis
Number of hypoglycemia episodes in each group will by analyzed at third visit, to check whether there is a difference between the groups.
Measured: 0-4 weeks after the recruitment visit
Physical activity during one month analysis
Number of footsteps walk per day in each group will by analyzed at the third follow-up visit.
Measured: 0-4 weeks after the recruitment visit
Compliance with diet recommendations
Diet assessment in each group will be performed at the second, third and fourth follow-up visit to check compliance with diet recommendations.
Measured: 2, 4 and 8 weeks after the recruitment visit
Gestational weight gain
Gestational weight gain in each group will by analyzed at the second, third and fourth follow-up visit.
Measured: 2, 4 and 8 weeks after the recruitment visit
Mode of delivery (rate of vaginal delivery/ Cesarean section)
Rate of vaginal delivery versus cesarean section in each group will by analyzed at the fifth follow-up visit.
Measured: 24-72 hours after the delivery
Fetal birth-weight
Fetal birth-weight in each group will by analyzed at the fifth follow-up visit.
Measured: 24-72 hours after the delivery
Neonatal glycemia
Neonatal glycemia in each group will by analyzed at the fifth follow-up visit, to check the rate of neonatal hypoglycemia.
Measured: 24-72 hours after the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Oct 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AGATA MAJEWSKA, Medical University of Warsaw
- Investigators
- Mirosław Wielgoś, MD PhD, Prof., Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422821
- Sponsor's protocol ID
- 931156
- Acronym
- FLAMINGO
- Status last verified
- Dec 2022
- First submitted
- 31 May 2020
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request.
Publications
Scott EM, Bilous RW, Kautzky-Willer A. Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):180-188. doi: 10.1089/dia.2017.0386. Epub 2018 Feb 22.
PubMed 29470094Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
PubMed 27634581Mancini G, Berioli MG, Santi E, Rogari F, Toni G, Tascini G, Crispoldi R, Ceccarini G, Esposito S. Flash Glucose Monitoring: A Review of the Literature with a Special Focus on Type 1 Diabetes. Nutrients. 2018 Jul 29;10(8):992. doi: 10.3390/nu10080992.
PubMed 30060632Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24.
PubMed 29278709Majewska A, Stanirowski PJ, Tatur J, Wojda B, Radosz I, Wielgos M, Bomba-Opon DA. Flash glucose monitoring in gestational diabetes mellitus (FLAMINGO): a randomised controlled trial. Acta Diabetol. 2023 Sep;60(9):1171-1177. doi: 10.1007/s00592-023-02091-2. Epub 2023 May 10.
PubMed 37160787Majewska A, Stanirowski P, Wielgos M, Bomba-Opon D. Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 2;11(3):e041486. doi: 10.1136/bmjopen-2020-041486.
PubMed 33653744
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04422821
- Acronym / sponsor ID
- FLAMINGO / 931156
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- gestational diabetes mellitus, flash glucose monitoring, glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 9 Jun 2020 (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.
Gestational diabetes mellitus (GDM) is glucose intolerance diagnosed for the first time in pregnancy. According to literature GDM affects 3-10% of pregnant women and is a risk factor for multiple maternal and fetal complications. During pregnancy GDM significantly increases the risk of fetal macrosomia, shoulder dystocia, birth trauma and Cesarean section. Furthermore, the long-term complications of GDM include increased risk of development of diabetes mellitus type 2 in the mother, as well as increased risk of obesity, diabetes and metabolic syndrome occurrence in their children. It has been well-documented that the risk of above-mentioned complications increases with the level of maternal hyperglycemia.
Proper glycemia control is one of the key elements in the effective treatment of GDM. Until recently, glucose monitoring was solely performed using glucose meters, which required multiple fingerpricks. Nowadays, due to the glycemia monitoring systems development, such as flash glucose monitoring (FGM), glucose levels may be measured less invasively through subcutaneous sensor application. As shown in one of the studies, FGM due to the ease of use, was 3 times more often applied as a method of glycemia control than SMBG. As a result, patients from FGM group had significantly better blood glucose control.
The main purpose of our study is to evaluate the impact of new method of glycemia control (FGM) on the efficacy of treatment of GDM. By analyzing results of this study, such as mean glycemia levels, number of women requiring insulin therapy and maternal-fetal perinatal outcomes the investigators will provide a scientific basis for more common use of FGM in the population of pregnant women affected by GDM.
Detailed description
This is a randomized controlled trial performed at the 1st Department of Obstetrics and Gynecology of Medical University of Warsaw. The study will recruit 100 women at 24-28 weeks of gestation . Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomized to Flash Glucose Monitoring (n=50) or Self-Monitoring of Blood Glucose (n=50) group.
The study group will obtain instruction for using Freestyle Libre app to measure and collect glycemia results using a mobile phone.
The control group will be informed about proper use of glucose meters.
All participants will be obliged to measure fasting and 1-h postprandial glucose concentrations in a daily manner, together with once per week midnight measurement.
All participants will obtain dietary recommendations for gestational diabetes mellitus and recommendations about daily physical activity in pregnancy.
In order to assess daily physical activity all participants will obtain a wristband allowing for footsteps measurement.
An evaluation of patient's dietary habits will be based on Eating Assessment Test prepared by the Polish National Institute of Public Health - National Institute of Hygiene.
Clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy.
After delivery, at the follow-up visit research staff will retrieve maternal and neonatal outcomes from patients medical history.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Libre™ | Experimental | Device: Flash Glucose MonitoringFreeStyle Libre™ will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will receive subcutaneous sensor for glucose monitoring (FreeStyle Libre™; Abbott Diabetes Care, Alameda, CA) for 4 weeks. |
| iXell® | Active comparator | Device: Self-Monitoring of Blood GlucoseiXell® will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will monitor glycemia through use of standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- singleton pregnancy between 24-28 weeks of gestation
- gestational diabetes mellitus diagnosis
Key exclusion criteria (11 listed)
- multiple pregnancy
- fetal malformations
- pre-gestational diabetes mellitus
- chronic or pregnancy-induced hypertension
- chronic renal or hepatic disease, in-vitro fertilization
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 |
|---|---|---|
| Flash Glucose MonitoringAlso: FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA)Flash Glucose Monitoring FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA) sensor placed subcutaneously that will be applied for 14 days, then removed and changed for the second sensor for the next 14 days. | Device | FreeStyle Libre™ |
| Self-Monitoring of Blood GlucoseAlso: iXell®; Genexo sp; Warsaw, PolandSelf-Monitoring of Blood Glucose with a standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) performed through a skin-puncturing 4 times a day for 28 days. | Device | iXell® |
Primary outcome
Mean glycemia results (fasting and 1-h postprandial glucose concentrations)
Time frame: 28 days after the recruitment visit
Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus.
9 secondary outcomes
Number of patients requiring insulin therapy
Time frame: 2, 4 and 8 weeks after the recruitment visit
Long-term glycemic control using blood HbA1c serum concentration
Time frame: 4 and 8 weeks after the recruitment visit
Number of hypoglycemia episodes (glucose concentration <70 mg/dl) during one month analysis
Time frame: 0-4 weeks after the recruitment visit
Physical activity during one month analysis
Time frame: 0-4 weeks after the recruitment visit
Compliance with diet recommendations
Time frame: 2, 4 and 8 weeks after the recruitment visit
Gestational weight gain
Time frame: 2, 4 and 8 weeks after the recruitment visit
Mode of delivery (rate of vaginal delivery/ Cesarean section)
Time frame: 24-72 hours after the delivery
Fetal birth-weight
Time frame: 24-72 hours after the delivery
Neonatal glycemia
Time frame: 24-72 hours after the delivery
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 22 Dec 2022.
- Background: PubMed 29470094Scott EM, Bilous RW, Kautzky-Willer A. Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):180-188. doi: 10.1089/dia.2017.0386. Epub 2018 Feb 22.
- Background: PubMed 27634581Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
- Background: PubMed 30060632Mancini G, Berioli MG, Santi E, Rogari F, Toni G, Tascini G, Crispoldi R, Ceccarini G, Esposito S. Flash Glucose Monitoring: A Review of the Literature with a Special Focus on Type 1 Diabetes. Nutrients. 2018 Jul 29;10(8):992. doi: 10.3390/nu10080992.
- Background: PubMed 29278709Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24.
- Derived from this study: PubMed 37160787Majewska A, Stanirowski PJ, Tatur J, Wojda B, Radosz I, Wielgos M, Bomba-Opon DA. Flash glucose monitoring in gestational diabetes mellitus (FLAMINGO): a randomised controlled trial. Acta Diabetol. 2023 Sep;60(9):1171-1177. doi: 10.1007/s00592-023-02091-2. Epub 2023 May 10.
- Derived from this study: PubMed 33653744Majewska A, Stanirowski P, Wielgos M, Bomba-Opon D. Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 2;11(3):e041486. doi: 10.1136/bmjopen-2020-041486.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request.
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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. This study is not recruiting at the moment.
Mirosław Wielgoś, MD PhD, Prof. study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flash Glucose Monitoring and Self-Monitoring of Blood Glucose in people with Gestational Diabetes Mellitus, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 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 22 Dec 2022. 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 Poland. 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?
Mean glycemia results (fasting and 1-h postprandial glucose concentrations) (time frame: 28 days after the recruitment visit). 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 NCT04422821, which also lists 6 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 22 Dec 2022.