Gestational DiabetesTELESUR-GDMNCT05510583
MyDiabby Healthcare Vs Diary in Gestational Diabetes Mellitus.
An observational study of Gestational Diabetes, run by Hôpital NOVO at 1 site in France.
Trial summary
The purpose of the study is to demonstrate the non-inferiority of the onset of maternal, foetal, and neonatal complications for patients who had Gestational diabetes mellitus (GDM) and who had been monitored by myDiabby Healthcare compared to patients who had a classic glycemic blood monitoring by diary Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Treated group
- How many people
- 668 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2022to 17 Apr 2023
- Phase
- Observational
- 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
Study population: Pregnant women (≥ 18 years old) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015 for the control group (paper blood glucose diaries) or between 01/01/2021 and 31/12/2021 if they have benefited from remote monitoring with myDiabby Healthcare
Who may be able to join
- Age ≥18 years old
- Date of delivery between 01/01/2013 and 30/06/2015 Or
- Date of delivery between 01/01/2021 and 31/12/2021 and monitored by myDiabby Healthcare
- Patients who had a gestational diabetes tested according to CNGOF recommendations
Who cannot join
- Patients with type 2 or type 1 diabetes
- Opposition of the patient for participating to the study
- Patients who have had a multiple pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Endocrinology department - Centre Hospitalier René Dubos
Pontoise, 95300
About this study
Official title: Non Inferiority Study of Glycemic Monitoring Via MyDiabby Healthcare Vs Conventional Diary in Patients with Gestational Diabetes Mellitus
The purpose of the study is to demonstrate the non-inferiority of the onset of maternal, foetal, and neonatal complications for patients who had Gestational diabetes mellitus (GDM) and who had been monitored by myDiabby Healthcare compared to patients who had a classic glycemic blood monitoring by diary
Read the detailed description
TELESUR-GDM is a descriptive and comparative study which will be compared to ERD2 study. ERD2 (personal data) was a retrospective study leaded in Rene Dubos hospital. The primary objective was to evaluate de proportion of patients who had a blood screening for type 2 diabetes after having a gestational diabetes and who gave birth between 2013 and 2015 in Rene Dubos hospital. The primary outcome was the discovery of a diabetes after the OGTT test (75g of glucose), 2 to 3 months after delivery, a fasting blood glucose rate ≥ 1,26 g/L and a plasma glucose after 2 hours ≥ 2g/L
- In ERD2 study 391 subjects were included. The patients were over 18 years old and had a gestational diabetes and were informed by a survey. The main criteria of maternal and neonatal complications were a maternal high blood pressure, a neonatal jaundice, neonatal hypocalcemia and hypoglycemia, and shoulders dystocia. In this study the patients were followed up with classic diary for glycemic blood rate.
- With TELESUR-GDM study, the objective is to prove the non-inferiority of the new method of monitoring for blood glucose rate (myDiabby Healthcare) for patients who had a gestational diabetes and who gave birth between 01/01/2021 and the 31/12/2021. The data will be collected with an informatic secured data base.
- Conditions
- Gestational Diabetes
- Being tested
- Control group, Treated group
- Keywords
- diabetes mellitus, tele-medicine, Pregnancy
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Retrospective study on pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015. Patients received traditional paper-based blood glucose monitoring.
Treated groupOther
Retrospective study on pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2021 and 31/12/2021. Patients received remote monitoring with myDiabby Healthcare
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015. Patients received traditional paper-based blood glucose monitoring. Receives: Other: Control group | |
| Group 2 | Pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2021 and 31/12/2021. Patients received remote monitoring with myDiabby Healthcare Receives: Other: Treated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups
Comparison, for patients with GDM, of the composite score (maternal / foetal - neonatal) between the group with remote monitoring by the myDiabby Healthcare and the group of patients with traditional monitoring (paper glycemic diaries). For each item answered "yes" count 1 point and "no" count 0 point.
For information, the composite score is based on the following items:
Maternal :
- High blood pressure (≥140/90 mmHG)
- Caesarean section
- Instrumental extraction
- Perineal Trauma : complete or complicated perineal tearing
- Pre-eclampsia
Foetal and neonatal :
- birth weight ≥ 95th percentile for gestational age (neonatal macrosomia)
- intrauterine growth restriction (birth weight ≤ 5th percentile)
- APGAR < 7 at 5 minutes
- Fetal death in utero
- Neonatal hypoglycemia
- Neonatal hypocalcemia
- Neonatal acidosis : pH<7,10 and lactate >6µmol
- Shoulders dystocia
- Collarbone fracture, brachial plexus
- Neonatal jaundice
Measured: At the end of the Study, an average of 8 month
Secondary outcomes (2)
Comparison, for each maternal and each Foetal/Neonatal composite items, between both groups
Prevalence of each maternal and each Foetal/Neonatal composite item in each group. For each item answered "yes" count 1 point and "no" count 0 point
For information, the maternal composite items are as follows:
- High blood pressure (≥140/90 mmHG)
- Hospitalization during pregnancy
- Caesarean section
- Instrumental extraction
- Perineal Trauma : complete or complicated perineal tearing
- Pre-eclampsia
For information, the Foetal/Neonatal composite items are as follows:
- birth weight ≥ 95th percentile for gestational age (neonatal macrosomia)
- intrauterine growth restriction (birth weight ≤ 5th percentile)
- APGAR <7 at 5 minutes
- Fetal death in utero
- Neonatal hypoglycemia
- Neonatal hypocalcemia
- Neonatal acidosis : pH<7,10 and lactate >6µmol
- Shoulders dystocia
- Collarbone fracture, brachial plexus
- Neonatal jaundice
Measured: At the end of the Study, an average of 8 month
Comparison of the rate of patients put on insulin in both groups
Number of patients put on insulin in each group and comparison.
Measured: At the end of the Study, an average of 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start2 Aug 2022
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr Christophe Poncelet, Principal investigator, Hôpital NOVODr Catherine Campinos, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510583
- Sponsor's protocol ID
- CHRD2421
- Acronym
- TELESUR-GDM
- Status last verified
- May 2023
- First submitted
- 19 Aug 2022
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Inferiority Study of Glycemic Monitoring Via MyDiabby Healthcare Vs Conventional Diary in Patients with Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05510583
- Acronym / sponsor ID
- TELESUR-GDM / CHRD2421
- Conditions
- Gestational Diabetes
- Keywords
- diabetes mellitus, tele-medicine, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 22 Aug 2022 (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 the study is to demonstrate the non-inferiority of the onset of maternal, foetal, and neonatal complications for patients who had Gestational diabetes mellitus (GDM) and who had been monitored by myDiabby Healthcare compared to patients who had a classic glycemic blood monitoring by diary
Detailed description
TELESUR-GDM is a descriptive and comparative study which will be compared to ERD2 study. ERD2 (personal data) was a retrospective study leaded in Rene Dubos hospital. The primary objective was to evaluate de proportion of patients who had a blood screening for type 2 diabetes after having a gestational diabetes and who gave birth between 2013 and 2015 in Rene Dubos hospital. The primary outcome was the discovery of a diabetes after the OGTT test (75g of glucose), 2 to 3 months after delivery, a fasting blood glucose rate ≥ 1,26 g/L and a plasma glucose after 2 hours ≥ 2g/L
- In ERD2 study 391 subjects were included. The patients were over 18 years old and had a gestational diabetes and were informed by a survey. The main criteria of maternal and neonatal complications were a maternal high blood pressure, a neonatal jaundice, neonatal hypocalcemia and hypoglycemia, and shoulders dystocia. In this study the patients were followed up with classic diary for glycemic blood rate.
- With TELESUR-GDM study, the objective is to prove the non-inferiority of the new method of monitoring for blood glucose rate (myDiabby Healthcare) for patients who had a gestational diabetes and who gave birth between 01/01/2021 and the 31/12/2021. The data will be collected with an informatic secured data base.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Control groupPregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015. Patients received traditional paper-based blood glucose monitoring. |
| Group 2 | – | Other: Treated groupPregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2021 and 31/12/2021. Patients received remote monitoring with myDiabby Healthcare |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women (≥ 18 years old) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015 for the control group (paper blood glucose diaries) or between 01/01/2021 and 31/12/2021 if they have benefited from remote monitoring with myDiabby Healthcare
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Date of delivery between 01/01/2013 and 30/06/2015 Or
- Date of delivery between 01/01/2021 and 31/12/2021 and monitored by myDiabby Healthcare
- Patients who had a gestational diabetes tested according to CNGOF recommendations
Key exclusion criteria (3 listed)
- Patients with type 2 or type 1 diabetes
- Opposition of the patient for participating to the study
- Patients who have had a multiple pregnancy
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 |
|---|---|---|
| Control groupRetrospective study on pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015. Patients received traditional paper-based blood glucose monitoring. | Other | Group 1 |
| Treated groupRetrospective study on pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2021 and 31/12/2021. Patients received remote monitoring with myDiabby Healthcare | Other | Group 2 |
Primary outcome
Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups
Time frame: At the end of the Study, an average of 8 month
Comparison, for patients with GDM, of the composite score (maternal / foetal - neonatal) between the group with remote monitoring by the myDiabby Healthcare and the group of patients with traditional monitoring (paper glycemic diaries). For each item answered "yes" count 1 point and "no" count 0 point. For information, the composite score is based on the following items: Maternal : * High blood pressure (≥140/90 mmHG) * Caesarean section * Instrumental extraction * Perineal Trauma : complete or complicated perineal tearing * Pre-eclampsia Foetal and neonatal : * birth weight ≥ 95th percentile for gestational age (neonatal macrosomia) * intrauterine growth restriction (birth weight ≤ 5th percentile) * APGAR < 7 at 5 minutes * Fetal death in utero * Neonatal hypoglycemia * Neonatal hypocalcemia * Neonatal acidosis : pH<7,10 and lactate >6µmol * Shoulders dystocia * Collarbone fracture, brachial plexus * Neonatal jaundice
2 secondary outcomes
Comparison, for each maternal and each Foetal/Neonatal composite items, between both groups
Time frame: At the end of the Study, an average of 8 month
Comparison of the rate of patients put on insulin in both groups
Time frame: At the end of the Study, an average of 8 month
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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 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.
Pr Christophe Poncelet principal investigator
Hôpital NOVO
Dr Catherine Campinos principal investigator
Hôpital NOVO
1 site 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, run by Hôpital NOVO at 1 site in France.
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 3 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 19 Sep 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 France. 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?
Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups (time frame: At the end of the Study, an average of 8 month). 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 19 Sep 2024.