Commercial or Open Source Closed Loop Impact on Pregnancy Study (COSCLIP)

July 24, 2026 updated by: University of California, San Francisco

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?

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pregnant individuals with type 1 diabetes (T1D) using any form of automated insulin delivery (AID) system in pregnancy

Description

Inclusion criteria:

  • Pregnant
  • Diagnosis of type 1 diabetes (T1D) prior to pregnancy
  • Active use of automated insulin delivery (AID) system

Exclusion criteria:

  • Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Commercial AID system
Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy
Other: Commercial AID system
AID system that is commercially available and FDA approved for use
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
Other: Open source AID system
AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Large for gestational age (LGA)
Time Frame: At delivery
Primary neonatal outcome. LGA defined as birth weight > 90th percentile for gestational age
At delivery
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.
From enrollment to 8 weeks postpartum
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).
From enrollment to 8 weeks postpartum.
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.
From enrollment to 8 weeks postpartum.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of cesarean delivery
Time Frame: At delivery
At delivery
Incidence of neonatal hypoglycemia
Time Frame: From delivery to 28 days-of-life
From delivery to 28 days-of-life
Incidence of neonatal hyperbilirubinemia
Time Frame: From delivery to 28 days-of-life
From delivery to 28 days-of-life
Incidence of neonatal ICU admission
Time Frame: From delivery to 28 days-of-life
From delivery to 28 days-of-life
Incidence of small for gestational age (SGA)
Time Frame: At delivery
SGA defined as birth weight < 10th percentile for gestational age.
At delivery
Incidence of perinatal mortality
Time Frame: From delivery to 28 days-of-life
Includes intrauterine fetal demise and neonatal demise
From delivery to 28 days-of-life
Incdience of diabetic ketoacidosis
Time Frame: From enrollment to 8 weeks postpartum
From enrollment to 8 weeks postpartum
Incidence of maternal hypoglycemia
Time Frame: From enrollment to 8 weeks postpartum
From enrollment to 8 weeks postpartum
Incidence of major congenital malformations
Time Frame: From enrollment to delivery (up to 40 weeks of delivery)
From enrollment to delivery (up to 40 weeks of delivery)
Incidence of pregnancy loss
Time Frame: From enrollment to delivery (up to 40 weeks of delivery)
From enrollment to delivery (up to 40 weeks of delivery)
Time above pregnancy-specific range (psTAR)
Time Frame: From enrollment to 8 weeks postpartum.
Defined as percent of time spent with sensor glucose > 140 mg/dL.
From enrollment to 8 weeks postpartum.
Time spent below pregnancy-specific range (psTBR)
Time Frame: From enrollment to 8 weeks postpartum.
Defined as percent of time spent with sensor glucose < 63 mg/dL.
From enrollment to 8 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nasim Sobhani, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-42036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD that underlie results in a publication

IPD Sharing Time Frame

Beginning 6 months and ending 2 years after the publication of results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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