Pilot Study of Intrapartum Insulin Pump

NCT07420972 | Not Yet Recruiting

• 1 other identifier: 00010027
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes; Diabetes (Insulin-requiring, Type 1 or Type 2); Pregnancy

Keywords

Insulin pump; Diabetes; Type 1 diabetes; Labor; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Feasibility Metrics

  Recruitment rate (number of participants)

  Study enrollment at beginning of labor until delivery

Secondary Outcomes (7)

• Protocol Adherence

  From study enrollment at beginning of labor until delivery

• Time in target glucose range during labor

  From the time of study enrollment at the beginning of labor until delivery

• Maternal hypoglycemia

  From the time of study enrollment at the beginning of labor until delivery

• Maternal hyperglycemia

  From the time of study enrollment at the beginning of labor until delivery

• Neonatal hypoglycemia

  From delivery until day of life 1

Study Arms (2)

Continuation of insulin pump therapy intrapartum

EXPERIMENTAL

Patients with type 1 or 2 diabetes already on insulin pump therapy for at least 2 months with continued utilization of insulin pump for blood glucose management while in labor (intrapartum)

Device: Insulin pump

Retrospective historic cohort with standard care (intravenous insulin drip) intrapartum

NO INTERVENTION

Retrospective historic cohort of patients with type 1 or 2 diabetes with antenatal use of insulin pump, managed with standard care (discontinuation of insulin pump and transition to intravenous insulin drip) in labor (intrapartum)

Interventions

Insulin pump DEVICE

Intrapartum continuation of insulin pump therapy

Also known as: Hybrid closed loop automated insulin delivery (AID) system

Continuation of insulin pump therapy intrapartum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Planned cesarean delivery without labor
• Significant comorbidities affecting insulin requirements (e.g., steroid therapy)
• Stillbirth prior to presenting for delivery
• Known severe fetal anomalies.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Latham Fund: collaborator

Related Publications (13)

• Baker AB, Cowie RW, Colliss JE. Effects of varying inspiratory flow waveform and time in intermittent positive pressure ventilation. III: Blockade of the autonomic nervous system. Br J Anaesth. 1977 Dec;49(12):1235-7. doi: 10.1093/bja/49.12.1235.

  PMID: 337988 BACKGROUND

• Dude A, Niznik CM, Szmuilowicz ED, Peaceman AM, Yee LM. Management of Diabetes in the Intrapartum and Postpartum Patient. Am J Perinatol. 2018 Sep;35(11):1119-1126. doi: 10.1055/s-0038-1629903. Epub 2018 Mar 13.

  PMID: 29534258 BACKGROUND

• Feldberg D, Dicker D, Samuel N, Peleg D, Karp M, Goldman JA. Intrapartum management of insulin-dependent diabetes mellitus (IDDM) gestants. A comparative study of constant intravenous insulin infusion and continuous subcutaneous insulin infusion pump (CSIIP). Acta Obstet Gynecol Scand. 1988;67(4):333-8.

  PMID: 3051881 BACKGROUND

• Yamamoto JM, Benham J, Mohammad K, Donovan LE, Wood S. Intrapartum glycaemic control and neonatal hypoglycaemia in pregnancies complicated by diabetes: a systematic review. Diabet Med. 2018 Feb;35(2):173-183. doi: 10.1111/dme.13546.

  PMID: 29117445 BACKGROUND

• Fishel Bartal M. Intrapartum Care for People with Diabetes-Working towards Evidence-Based Management. Am J Perinatol. 2025 Jul;42(9):1103-1108. doi: 10.1055/a-2405-1846. Epub 2024 Aug 29.

  PMID: 39209305 BACKGROUND

• Castorino K, Paband R, Zisser H, Jovanovic L. Insulin pumps in pregnancy: using technology to achieve normoglycemia in women with diabetes. Curr Diab Rep. 2012 Feb;12(1):53-9. doi: 10.1007/s11892-011-0242-7.

  PMID: 22105415 BACKGROUND

• Drever E, Tomlinson G, Bai AD, Feig DS. Insulin pump use compared with intravenous insulin during labour and delivery: the INSPIRED observational cohort study. Diabet Med. 2016 Sep;33(9):1253-9. doi: 10.1111/dme.13106. Epub 2016 Mar 20.

  PMID: 26927202 BACKGROUND

• Ryan EA, Al-Agha R. Glucose control during labor and delivery. Curr Diab Rep. 2014 Jan;14(1):450. doi: 10.1007/s11892-013-0450-4.

  PMID: 24292970 BACKGROUND

• Wilkie G, Orr L, Leung K, Leftwich H. Comparison of intrapartum glycemic management strategies in pregnant women with type 1 diabetes mellitus. J Matern Fetal Neonatal Med. 2022 Dec;35(25):8756-8760. doi: 10.1080/14767058.2021.2004114. Epub 2021 Dec 6.

  PMID: 34871147 BACKGROUND

• Beunen K, Gillard P, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, Nobels F, Van Huffel L, Marlier J, Lee D, Cuypers J, Preumont V, Siegelaar SE, Painter RC, Laenen A, Mathieu C, Benhalima K. Advanced Hybrid Closed-Loop Therapy Compared With Standard Insulin Therapy Intrapartum and Early Postpartum in Women With Type 1 Diabetes: A Secondary Observational Analysis From the CRISTAL Randomized Controlled Trial. Diabetes Care. 2024 Nov 1;47(11):2002-2011. doi: 10.2337/dc24-1320.

  PMID: 39331059 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.

  PMID: 30461693 BACKGROUND

• Toledo-Chavarri A, Delgado J, Padilla M, Rodriguez-Martin B. A Qualitative Evidence Synthesis of Continuous Subcutaneous Insulin Infusion: Acceptability, Implementation, Equity. Nurs Health Sci. 2024 Dec;26(4):e13177. doi: 10.1111/nhs.13177.

  PMID: 39428561 BACKGROUND

• American Diabetes Association Professional Practice Committee. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S306-S320. doi: 10.2337/dc25-S015.

  PMID: 39651985 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Infusion Systems; Insemination, Artificial, Heterologous; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment; Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Victoria Greenberg, MD

  MedStar Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Greenberg, MD

CONTACT

301-782-3353; victoria.r.greenberg@medstar.net

Elizabeth Miller, MD

CONTACT

elizabeth.miller@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a quasi-experimental, non-randomized design consisting of two arms: a prospectively enrolled cohort managed with CSII/AID during labor and a matched historical cohort managed with IV insulin

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 19, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-01