NCT07420972Not yet recruiting
Pilot Study of Intrapartum Insulin Pump
Pilot Study of Intrapartum Insulin Pump Use: Feasibility, Efficacy and Safety
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
People with type 1 or type 2 diabetes often use insulin pumps to manage their blood sugar during pregnancy. These pumps can help keep blood sugar in a healthy range. However, when people come to the hospital to give birth, they are often asked to stop using their insulin pump and switch to insulin given through an IV. This change can be stressful and may make blood sugar harder to control during labor. There is not enough research to know if it is safe and practical for people to keep using their insulin pump while in labor. The goal of this study is to learn whether it is safe, practical, and acceptable for pregnant people with diabetes to continue using their insulin pump during labor. The study will also look at how this approach compares to standard care, which uses IV insulin. This is a small pilot study. About 30 pregnant people with type 1 or type 2 diabetes will take part. All participants already use an insulin pump and receive care through the MedStar Diabetes in Pregnancy Program. Participants will be allowed to continue using their own insulin pump during labor, following a hospital safety plan. Their outcomes will be compared to similar patients from the past who used IV insulin during labor. The main focus of the study is to see how often people can safely stay on their insulin pump during labor and how well this approach fits into hospital care. The study will also collect information about blood sugar levels during labor and health outcomes for newborns, such as low blood sugar, breathing problems, or need for care in the neonatal intensive care unit. These outcomes are being studied to help plan future research. After delivery, participants will be asked to share their experience. This includes how satisfied they were with their diabetes care during labor, how much control they felt over their care, and how difficult or easy the treatment was to manage. Nurses and doctors will also provide feedback about caring for patients who use insulin pumps during labor. Participants will continue to check their blood sugar using continuous glucose monitoring, with fingerstick checks when needed. If any safety concerns arise, such as blood sugar levels that are too high or too low, participants will switch to standard IV insulin. This study is not meant to prove that one method is better than another. Instead, it will help researchers decide whether a larger study should be done in the future. The long-term goal is to improve diabetes care during labor and support safe, patient-centered options for people with diabetes and their babies.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 28 Jan 2026
- Start date
- Apr 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- Medstar Health Research Institute
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07420972
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Apr 2026 to the primary completion date, Feb 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Significant comorbidities affecting insulin requirements (e.g., steroid therapy)
- Stillbirth prior to presenting for delivery
Other
- Planned cesarean delivery without labor
- Known severe fetal anomalies.
Who the study is looking for
- Singleton gestation
- Established Type 1 or 2 diabetes mellitus
- Use of continuous subcutaneous insulin infusion for ≥2 months prior to delivery, -Demonstrated cognitive ability to self-manage insulin, familiarity with pump technology, availability of necessary supplies, stable clinical status
- Ability to provide informed consent
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.