Type 1 DiabetesIADIABENCEINNCT05661149
Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)
An observational study of Type 1 Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The imbalance of diabetes is associated with an increased risk of maternal and fetal complications. In women, it can cause abortion, hypertension, preeclampsia, and obstructed labor; in the fetus, it increases the risk of many malformations, including neurological and cardiac, fetal death in utero, intrauterine growth… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Hybrid closed loop insulin delivery systems
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2023to 11 Dec 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien
Who may be able to join
- aged at least 18 years
- had been diagnosed with type 1 diabetes before pregnancy
- using an hybrid closed-loop insulin delivery system before or at any time of pregnancy
Who cannot join
- Patient opposed to the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed-Loop Insulin Delivery in Pregnant Women with Type 1 Diabetes
The imbalance of diabetes is associated with an increased risk of maternal and fetal complications. In women, it can cause abortion, hypertension, preeclampsia, and obstructed labor; in the fetus, it increases the risk of many malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity and metabolic complications.
Despite the various therapeutic tools available and used during pregnancy, maintaining blood sugar levels within this narrow range remains a challenge.
Automated Insulin Therapy (IA) Could Further Improve Outcomes With Continuous Glucose Monitoring and Increase Percentage of Time Spent on Target Between 63 and 140 mg/dL The objective of this observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1D treated during pregnancy with an AI system available in France.
Read the detailed description
Diabetes imbalance is associated with an increased risk of maternal and fetal complications, and achieving target blood glucose levels before and during pregnancy in women with type 1 diabetes (T1DM) significantly reduces these complications. In women, it can cause abortion, hypertension, pre-eclampsia, and dystocic deliveries; in the fetus, it increases the risk of numerous malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity, and metabolic complications at birth such as neonatal hypoglycemia and hypocalcemia.
The recommended glycemic targets during pregnancy are strict: HbA1c < 6.5% and time in target (between 63 and 140 mg/dL) > 70% (6).
Despite the various therapeutic tools available and used during pregnancy, maintaining blood glucose within this narrow range remains a challenge.
Automated insulin therapy (AI) could improve further on the results obtained with continuous glucose monitoring and increase the percentage of time spent in target between 63 and 140 mg/dL The objective of this present observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1DM treated during pregnancy with an AI system available in France, whether this system is used before the beginning of the pregnancy or during it.
- Conditions
- Type 1 Diabetes
- Being tested
- Hybrid closed loop insulin delivery systems
- Keywords
- artificial pancreas, closed loop insulin delivery, glucose control, pregnancy, type 1 diabetes, observational study
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid closed loop insulin delivery systemsDevice
Tandem Control-IQ ; DBLG1 system ; MiniMed 780G system
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Data drawn from continuous glucose monitoring systems
Measured: 12 weeks before the start of pregnancy (week 0)
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Data drawn from continuous glucose monitoring systems
Measured: week 0
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Data drawn from continuous glucose monitoring systems
Measured: Week 14
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Data drawn from continuous glucose monitoring systems
Measured: Week 26
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Data drawn from continuous glucose monitoring systems
Measured: Wekk 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start11 May 2023
- Primary completion30 Aug 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred PENFRONIS, PHD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661149
- Sponsor's protocol ID
- 2022/0036
- Acronym
- IADIABENCEIN
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2022
- Last updated
- 26 Nov 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Insulin Delivery in Pregnant Women with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05661149
- Acronym / sponsor ID
- IADIABENCEIN / 2022/0036
- Conditions
- Type 1 Diabetes
- Keywords
- artificial pancreas, closed loop insulin delivery, glucose control, pregnancy, type 1 diabetes, observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 22 Dec 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 imbalance of diabetes is associated with an increased risk of maternal and fetal complications. In women, it can cause abortion, hypertension, preeclampsia, and obstructed labor; in the fetus, it increases the risk of many malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity and metabolic complications.
Despite the various therapeutic tools available and used during pregnancy, maintaining blood sugar levels within this narrow range remains a challenge.
Automated Insulin Therapy (IA) Could Further Improve Outcomes With Continuous Glucose Monitoring and Increase Percentage of Time Spent on Target Between 63 and 140 mg/dL The objective of this observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1D treated during pregnancy with an AI system available in France.
Detailed description
Diabetes imbalance is associated with an increased risk of maternal and fetal complications, and achieving target blood glucose levels before and during pregnancy in women with type 1 diabetes (T1DM) significantly reduces these complications. In women, it can cause abortion, hypertension, pre-eclampsia, and dystocic deliveries; in the fetus, it increases the risk of numerous malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity, and metabolic complications at birth such as neonatal hypoglycemia and hypocalcemia.
The recommended glycemic targets during pregnancy are strict: HbA1c < 6.5% and time in target (between 63 and 140 mg/dL) > 70% (6).
Despite the various therapeutic tools available and used during pregnancy, maintaining blood glucose within this narrow range remains a challenge.
Automated insulin therapy (AI) could improve further on the results obtained with continuous glucose monitoring and increase the percentage of time spent in target between 63 and 140 mg/dL The objective of this present observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1DM treated during pregnancy with an AI system available in France, whether this system is used before the beginning of the pregnancy or during it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien
Key inclusion criteria (3 listed)
- aged at least 18 years
- had been diagnosed with type 1 diabetes before pregnancy
- using an hybrid closed-loop insulin delivery system before or at any time of pregnancy
Key exclusion criteria (1 listed)
- Patient opposed to the research
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 |
|---|---|---|
| Hybrid closed loop insulin delivery systemsTandem Control-IQ ; DBLG1 system ; MiniMed 780G system | Device | – |
Primary outcome
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time frame: 12 weeks before the start of pregnancy (week 0)
Data drawn from continuous glucose monitoring systems
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time frame: week 0
Data drawn from continuous glucose monitoring systems
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time frame: Week 14
Data drawn from continuous glucose monitoring systems
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time frame: Week 26
Data drawn from continuous glucose monitoring systems
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time frame: Wekk 38
Data drawn from continuous glucose monitoring systems
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 26 Nov 2024.
- 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. This study is not recruiting at the moment.
Alfred PENFRONIS, PHD principal investigator
Centre Hospitalier Sud Francilien
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 Type 1 Diabetes, run by Centre Hospitalier Sud Francilien 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 3 inclusion and 1 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 26 Nov 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?
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL) (time frame: 12 weeks before the start of pregnancy (week 0)). The study lists 5 primary outcomes in all. 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 26 Nov 2024.