Diabetes Mellitus, Type 1PRAM-T1DNCT06959316
T1D Pregnancy & Me
An observational study of Diabetes Mellitus, Type 1 and Pregnancy in Diabetics, run by Jaeb Center for Health Research at 10 sites in United States.
Trial summary
T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus, Type 1, Pregnancy in Diabetics, Pregnancy, High-Risk
- What is being tested?
- Hybrid closed loop insulin delivery system
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 Apr 2025to Apr 2027
- Phase
- Observational
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 adults with type 1 diabetes from across the United States who use a continuous glucose monitor.
Who may be able to join
- Age ≥18 years
- Clinical diagnosis of presumed T1D for at least 6 months duration
- Less than 15 weeks gestation at time of enrollment based on due date from provider
- Planned CGM use on a regular basis (e.g., ≥10 out of 14 days) and willing to continue using CGM regularly with no plans to discontinue CGM use during the study
- Following intensive insulin therapy regimen defined as basal-bolus delivery via an insulin pump (including a closed loop system) or multiple daily injections (MDI)
- Have access to technology that may be required to complete study questionnaires and share diabetes device data.
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- Resident of the United States and plans to reside in the U.S. for the duration of the study
- Comprehends written and spoken English or Spanish
- Willing and able to provide informed consent, complete surveys and provide the device data that are part of the protocol
Who cannot join
- Multiple pregnancy
- Current renal dialysis or plan to begin renal dialysis during the study
- History of liver cirrhosis
- Active cancer treatment with systemic chemotherapy
- Current participation in other studies involving an investigational insulin delivery device or planning to participate in an investigational insulin delivery device study during pregnancy
- Prior participation in this study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Barbara Davis Center for Diabetes & University of Colorado Health
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Mass General Brigham
Boston, Massachusetts, 02114
Joslin Diabetes Center
Boston, Massachusetts, 02215
The Ohio State University
Columbus, Ohio, 43210
Indiana University
Indianapolis, Indiana, 46202
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health and Science University
Portland, Oregon, 97239
Jaeb Center for Health Research
Tampa, Florida, 33647
About this study
Official title: Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology
T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.
Read the detailed description
Type 1 diabetes (T1D) management during pregnancy is a critical area as pregnancy complicated by T1D is still associated with a markedly elevated risk of maternal and fetal complications. Because the risk of these complications is tightly linked to glucose levels, guidelines recommend lower glycemic targets than in non-pregnant individuals to optimize pregnancy outcomes. Hybrid closed loop (HCL) insulin delivery systems may aid in glycemic management during pregnancy, but options for use of HCL during pregnancy are limited and present challenges as systems are not approved for use in pregnancy and do not target pregnancy glycemic goals. Thus, pregnant individuals with T1D and their clinicians must consider off-label use of HCL systems with suboptimal glycemic targets. To get closer to pregnancy glycemic targets, individuals may adjust the way they use the system, but there is insufficient evidence to understand the impact of HCL systems available in the US on pregnancy glycemic metrics and pregnancy outcomes.
To address these gaps in evidence, we propose an observational study that will enable systematic assessment of HCL system use in pregnancies complicated by T1D. The focus of this study is to assess glycemic outcomes measured by continuous glucose monitors and clinical pregnancy outcomes associated with use of HCL versus other insulin delivery methods. Data collected from this study will provide important information about how individuals in the United States are managing their diabetes during pregnancy and will help us to identify factors that could minimize the risk of diabetes-associated pregnancy complications and reduce the burden that comes with managing T1D in pregnancy.
Pregnant individuals throughout the United States will be enrolled in this remote observational study. Participants will be asked to share details about their diabetes and pregnancy. Participants will also be asked to share diabetes device data from their continuous glucose monitor (CGM). Participants who use an insulin pump or connected insulin pen may also be asked to share these data.
- Conditions
- Diabetes Mellitus, Type 1, Pregnancy in Diabetics, Pregnancy, High-Risk, Insulin Dependent Diabetes
- Being tested
- Hybrid closed loop insulin delivery system
- Keywords
- Type 1 diabetes, Pregnant, Pregnancy, Insulin pump, Continuous glucose monitor, Remote study, Online study, T1D, CGM, Insulin injection, Hybrid closed loop, HCL
- Medical subject headings
- Diabetes Mellitus, Type 1, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid closed loop insulin delivery systemDevice
Hybrid closed loop insulin delivery system is a system that uses a continuous glucose monitor (CGM) to send blood glucose values to an insulin pump that automatically provides insulin based on the blood glucose value and anticipated future level.
| Study group | Role | What they receive |
|---|---|---|
| HCL Use | Pregnant individuals with type 1 diabetes (T1D) using HCL systems for glycemic management in pregnancy Receives: Device: Hybrid closed loop insulin delivery system | |
| HCL Non-Use | Pregnant individuals with type 1 diabetes (T1D) not using HCL systems for glycemic management in pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM Outcome (BG 63-140 mg/dl)
Percentage of time spent with glucose 63-140 mg/dl
Measured: Up to 37 weeks gestation
Secondary outcomes (3)
CGM Outcome (BG<63 mg/dl)
Percentage time spent with glucose <63 mg/dl
Measured: Up to 37 weeks gestation
CGM Outcome (BG<54 mg/dl)
Percentage time spent with glucose <54 mg/dl
Measured: Up to 37 weeks gestation
CGM Outcome (BG>140 mg/dl)
Percentage time spent with glucose >140 mg/dl
Measured: Up to 37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start25 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Robin Gal, MSPH, Principal investigator, Jaeb Center for Health ResearchCamille Powe, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959316
- Sponsor's protocol ID
- PRAM-T1D
- Acronym
- PRAM-T1D
- Status last verified
- Aug 2026
- First submitted
- 28 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided