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Type 1 DiabetesPhase 4NCT04599075

Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus

A Phase 4 study testing Insulin in people with Type 1 Diabetes and Pregnancy, High Risk, run by Gianna Wilkie at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. 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
What is being tested?
Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
15 Mar 2021to 2 May 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Pregnant women with pre-gestational diagnosis of type 1 diabetes mellitus and managed on an insulin pump in pregnancy
  • Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
  • Patients able to provide written informed consent

Who cannot join

  • Patients who are under the age of 18
  • Patients with altered state of consciousness
  • Critically ill patient requiring intensive care unit admission
  • Patient at risk for suicide
  • Patient refuses or is otherwise unable to participate in own care
  • Patient without pump supplies
  • Patients presenting with diabetic ketoacidosis on admission

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial

The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.

Read the detailed description

Intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. Some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions. Previous literature has retrospectively shown this to be both a feasible and safe option.

The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to obstetric and neonatal outcomes.

Being tested
Insulin
Keywords
Pregnancy, Type 1 Diabetes, Intrapartum Insulin, Maternal Outcomes, Neonatal Outcomes
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.

  • InsulinDrug

    Also called Insulin via IV Infusion

    IV Insulin Infusion

  • InsulinDrug

    Also called Insulin via Pump

    Continuous Subcutaneous Insulin Infusion (Pump)

Study groups in NCT04599075
Study groupRoleWhat they receive
Intravenous Insulin InfusionExperimentalPatients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.
Receives: Drug: Insulin
Continuous Subcutaneous Insulin Infusion (CSII)ExperimentalPatients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol.
Receives: Drug: Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal Hypoglycemia

    First neonatal blood sugar obtained within 2 hours of birth

    Measured: Within 2 hours of birth

Secondary outcomes (12)

  1. Number of Maternal Hypoglycemic Events

    Number of maternal blood sugars < 60 mg/dL

    Measured: During labor

  2. Development of Diabetic Ketoacidosis During Labor

    Development of Diabetic Ketoacidosis during labor

    Measured: During Labor

  3. Mode of Delivery

    Mode of Delivery (vaginal versus cesarean)

    Measured: At birth

  4. Neonatal Birthweight

    Neonatal Birthweight

    Measured: At Birth

  5. Number of Participants With Shoulder Dystocia

    Number of participants with shoulder dystocia

    Measured: At birth

  6. Number of Participants With Brachial Plexus Injury

    Number of participants with brachial plexus injury

    Measured: At birth

  7. 5 Minute Apgar Score < 7

    Neonatal Apgar Score: The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.

    Measured: At delivery (5 minutes)

  8. Received Neonatal Intervention for Hypoglycemia

    Received intervention for hypoglycemia (any oral, IV, or both)

    Measured: Within 24 hours of life

  9. Neonatal Intensive Care Unit Admission

    Admission to level 2 or greater neonatal ICU. This is a marker for additional need for neonatal support and care after delivery.

    Measured: At delivery and within first 2 day of life

  10. Gestational Age at Delivery

    Gestational age at delivery

    Measured: At birth

  11. Number of Participants With Neonatal Respiratory Distress

    Requiring 2 or more hours of respiratory support or oxygen with associated diagnosis

    Measured: At delivery

  12. Number of Participants With Neonatal Hyperbilirubinemia

    Requiring phototherapy

    Measured: Within first 2 days of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start15 Mar 2021
  3. Primary completion1 May 2023
  4. Study completion2 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, single-center, randomized study evaluating intrapartum insulin delivery management strategies among pregnant women with type 1 diabetes mellitus.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04599075
Sponsor's protocol ID
H00021746
Status last verified
Jul 2024
First submitted
16 Oct 2020
Last updated
8 Jul 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 3051881

  • Peterson C, Grosse SD, Li R, Sharma AJ, Razzaghi H, Herman WH, Gilboa SM. Preventable health and cost burden of adverse birth outcomes associated with pregestational diabetes in the United States. Am J Obstet Gynecol. 2015 Jan;212(1):74.e1-9. doi: 10.1016/j.ajog.2014.09.009. Epub 2014 Oct 28.

    PubMed 25439811

  • Professional Practice Committee for the Standards of Medical Care in Diabetes-2016. Diabetes Care. 2016 Jan;39 Suppl 1:S107-8. doi: 10.2337/dc16-S018. No abstract available.

    PubMed 26696673

  • 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.

    PubMed 26927202

  • Fresa R, Visalli N, Di Blasi V, Cavallaro V, Ansaldi E, Trifoglio O, Abbruzzese S, Bongiovanni M, Agrusta M, Napoli A. Experiences of continuous subcutaneous insulin infusion in pregnant women with type 1 diabetes during delivery from four Italian centers: a retrospective observational study. Diabetes Technol Ther. 2013 Apr;15(4):328-34. doi: 10.1089/dia.2012.0260. Epub 2013 Mar 28.

    PubMed 23537417

  • Wilkie GL, Delpapa E, Leftwich HK. Intrapartum continuous subcutaneous insulin infusion vs intravenous insulin infusion among pregnant individuals with type 1 diabetes mellitus: a randomized controlled trial. Am J Obstet Gynecol. 2023 Dec;229(6):680.e1-680.e8. doi: 10.1016/j.ajog.2023.07.003. Epub 2023 Jul 8.

    PubMed 37429432

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin in people with Type 1 Diabetes and Pregnancy, High Risk, run by Gianna Wilkie 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 7 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: finished, as of the sponsor's last update on 8 Jul 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal Hypoglycemia (time frame: Within 2 hours of birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04599075, which also lists 6 linked publications.

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 8 Jul 2024.

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