Type 1 DiabetesCOSCLIPNCT06654713
Commercial or Open Source Closed Loop Impact on Pregnancy Study
An observational study of Type 1 Diabetes and Pregnancy, High Risk, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are: What are the maternal and neonatal outcomes with AID system use in pregnancy? What are the glycemic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type 1 Diabetes, Pregnancy, High Risk, Insulin Dependent Diabetes
- What is being tested?
- Commercial AID system and Open source AID system
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 31 Dec 2029
- How long will I take part?
- 1 Year
- 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: Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy
Who may be able to join
- Pregnant
- Diagnosis of type 1 diabetes (T1D) prior to pregnancy
- Active use of automated insulin delivery (AID) system
Who cannot join
- Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Nasim Sobhani, 415-307-9319, COSCLIPStudy@UCSF.edu
About this study
Official title: Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:
- What are the maternal and neonatal outcomes with AID system use in pregnancy?
- What are the glycemic outcomes with AID system use in pregnancy?
- What are the behavioral and emotional outcomes with AID system use in pregnancy?
Read more
Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems.
Participants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.
- Being tested
- Commercial AID system, Open source AID system
- 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.
Commercial AID systemOther
AID system that is commercially available and FDA approved for use
Open source AID systemOther
AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor
| Study group | Role | What they receive |
|---|---|---|
| Commercial AID system | Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy Receives: Other: Commercial AID system | |
| Open source AID system | Pregnant individuals with type 1 diabetes T1D) using open source automated insulin delivery (AID) systems (also known as do-it-yourself AID systems or hacked AID systems) for glycemic management in pregnancy Receives: Other: Open source AID system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large for gestational age (LGA)
Primary neonatal outcome. LGA defined as birth weight > 90th percentile for gestational age
Measured: At delivery
Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)
Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress.
Measured: From enrollment to 8 weeks postpartum
Hypertensive disorders of pregnancy (HDP)
Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG).
Measured: From enrollment to 8 weeks postpartum.
Time in pregnancy-specific range (psTIR)
Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL.
Measured: From enrollment to 8 weeks postpartum.
Secondary outcomes (12)
Incidence of cesarean delivery
Measured: At delivery
Incidence of neonatal hypoglycemia
Measured: From delivery to 28 days-of-life
Incidence of neonatal hyperbilirubinemia
Measured: From delivery to 28 days-of-life
Incidence of neonatal ICU admission
Measured: From delivery to 28 days-of-life
Incidence of major congenital malformations
Measured: From enrollment to delivery (up to 40 weeks of delivery)
Incidence of small for gestational age (SGA)
SGA defined as birth weight < 10th percentile for gestational age.
Measured: At delivery
Incidence of pregnancy loss
Measured: From enrollment to delivery (up to 40 weeks of delivery)
Incidence of perinatal mortality
Includes intrauterine fetal demise and neonatal demise
Measured: From delivery to 28 days-of-life
Incdience of diabetic ketoacidosis
Measured: From enrollment to 8 weeks postpartum
Incidence of maternal hypoglycemia
Measured: From enrollment to 8 weeks postpartum
Time above pregnancy-specific range (psTAR)
Defined as percent of time spent with sensor glucose > 140 mg/dL.
Measured: From enrollment to 8 weeks postpartum.
Time spent below pregnancy-specific range (psTBR)
Defined as percent of time spent with sensor glucose < 63 mg/dL.
Measured: From enrollment to 8 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start13 Mar 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
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.
- More trials run by University of California, San FranciscoThe 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
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Sobhani, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654713
- Sponsor's protocol ID
- 24-42036
- Acronym
- COSCLIP
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
- ClinicalTrials.gov ID
- NCT06654713
- Acronym / sponsor ID
- COSCLIP / 24-42036
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Oct 2024 (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 goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:
- What are the maternal and neonatal outcomes with AID system use in pregnancy?
- What are the glycemic outcomes with AID system use in pregnancy?
- What are the behavioral and emotional outcomes with AID system use in pregnancy?
Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems.
Participants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial AID system | – | Other: Commercial AID systemPregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy |
| Open source AID system | – | Other: Open source AID systemPregnant individuals with type 1 diabetes T1D) using open source automated insulin delivery (AID) systems (also known as do-it-yourself AID systems or hacked AID systems) for glycemic management in pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy
Key inclusion criteria (3 listed)
- Pregnant
- Diagnosis of type 1 diabetes (T1D) prior to pregnancy
- Active use of automated insulin delivery (AID) system
Key exclusion criteria (1 listed)
- Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)
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 |
|---|---|---|
| Commercial AID systemAID system that is commercially available and FDA approved for use | Other | Commercial AID system |
| Open source AID systemAID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor | Other | Open source AID system |
Primary outcome
Large for gestational age (LGA)
Time frame: At delivery
Primary neonatal outcome. LGA defined as birth weight > 90th percentile for gestational age
Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)
Time frame: From enrollment to 8 weeks postpartum
Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress.
Hypertensive disorders of pregnancy (HDP)
Time frame: From enrollment to 8 weeks postpartum.
Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG).
Time in pregnancy-specific range (psTIR)
Time frame: From enrollment to 8 weeks postpartum.
Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL.
12 secondary outcomes
Incidence of cesarean delivery
Time frame: At delivery
Incidence of neonatal hypoglycemia
Time frame: From delivery to 28 days-of-life
Incidence of neonatal hyperbilirubinemia
Time frame: From delivery to 28 days-of-life
Incidence of neonatal ICU admission
Time frame: From delivery to 28 days-of-life
Incidence of major congenital malformations
Time frame: From enrollment to delivery (up to 40 weeks of delivery)
Incidence of small for gestational age (SGA)
Time frame: At delivery
Incidence of pregnancy loss
Time frame: From enrollment to delivery (up to 40 weeks of delivery)
Incidence of perinatal mortality
Time frame: From delivery to 28 days-of-life
Incdience of diabetic ketoacidosis
Time frame: From enrollment to 8 weeks postpartum
Incidence of maternal hypoglycemia
Time frame: From enrollment to 8 weeks postpartum
Time above pregnancy-specific range (psTAR)
Time frame: From enrollment to 8 weeks postpartum.
Time spent below pregnancy-specific range (psTBR)
Time frame: From enrollment to 8 weeks postpartum.
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 27 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD that underlie results in a publication
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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.
Nasim Sobhani, MD principal investigator
University of California, San Francisco
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 and Pregnancy, High Risk, run by University of California, San Francisco at 1 site in United States.
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: looking for participants now, as of the sponsor's last update on 27 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 1 site in United States. 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 Primary Investigator ((415) 307-9319, cosclipstudy@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large for gestational age (LGA) (time frame: At delivery). The study lists 4 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 27 Jul 2026.