NCT04599075 is a Phase 4 clinical trial of Insulin in Type 1 Diabetes, sponsored by Gianna Wilkie.

Who is sponsoring NCT04599075?

NCT04599075 is sponsored by Gianna Wilkie.

What drugs are being tested in NCT04599075?

Interventions in NCT04599075: Insulin, Insulin.

What condition does NCT04599075 study?

NCT04599075 studies Type 1 Diabetes, Pregnancy, High Risk.

Is NCT04599075 still recruiting?

NCT04599075 is currently completed. Last updated 8 July 2024.

Are results published for NCT04599075?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-08 · How we verify

NCT04599075

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 8 July 2024

What this trial tests

Phase 4 trial testing Insulin in Type 1 Diabetes in 70 participants. Completed in 2 May 2023.

Timeline

15 March 2021

Primary endpoint
1 May 2023

2 May 2023

Quick facts

Lead sponsor	Gianna Wilkie
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	15 March 2021
Primary completion	1 May 2023
Estimated completion	2 May 2023
Sites	1 location across United States

Drugs / interventions tested

Insulin (insulin) — full drug profile →
Insulin (insulin) — full drug profile →

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →
Pregnancy, High Risk — all drugs for Pregnancy, High Risk →

Sponsor

Gianna Wilkie

Who can join

18 and older, female only, with Type 1 Diabetes or Pregnancy, High Risk. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Neonatal Hypoglycemia Primary · Within 2 hours of birth

First neonatal blood sugar obtained within 2 hours of birth

Group	Value	95% CI
Intravenous Insulin Infusion	49.2	± 22.6
Continuous Subcutaneous Insulin Infusion (CSII)	50.1	± 23.4

Number of Maternal Hypoglycemic Events Secondary · During labor

Number of maternal blood sugars \< 60 mg/dL

Group	Value	95% CI
Intravenous Insulin Infusion	5
Continuous Subcutaneous Insulin Infusion (CSII)	1

Development of Diabetic Ketoacidosis During Labor Secondary · During Labor

Development of Diabetic Ketoacidosis during labor

Group	Value	95% CI
Intravenous Insulin Infusion	0
Continuous Subcutaneous Insulin Infusion (CSII)	0

Mode of Delivery Secondary · At birth

Mode of Delivery (vaginal versus cesarean)

Group	Value	95% CI
Intravenous Insulin Infusion	17
Continuous Subcutaneous Insulin Infusion (CSII)	23
Intravenous Insulin Infusion	16
Continuous Subcutaneous Insulin Infusion (CSII)	11
Intravenous Insulin Infusion	2
Continuous Subcutaneous Insulin Infusion (CSII)	1

Neonatal Birthweight Secondary · At Birth

Neonatal Birthweight

Group	Value	95% CI
Intravenous Insulin Infusion	3067.8	± 1035.8
Continuous Subcutaneous Insulin Infusion (CSII)	3293.3	± 883.7

Number of Participants With Shoulder Dystocia Secondary · At birth

Number of participants with shoulder dystocia

Group	Value	95% CI
Intravenous Insulin Infusion	4
Continuous Subcutaneous Insulin Infusion (CSII)	1

Number of Participants With Brachial Plexus Injury Secondary · At birth

Number of participants with brachial plexus injury

Group	Value	95% CI
Intravenous Insulin Infusion	0
Continuous Subcutaneous Insulin Infusion (CSII)	0

5 Minute Apgar Score < 7 Secondary · At delivery (5 minutes)

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.

Group	Value	95% CI
Intravenous Insulin Infusion	7
Continuous Subcutaneous Insulin Infusion (CSII)	3

Received Neonatal Intervention for Hypoglycemia Secondary · Within 24 hours of life

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

Group	Value	95% CI
Intravenous Insulin Infusion	18
Continuous Subcutaneous Insulin Infusion (CSII)	20

Neonatal Intensive Care Unit Admission Secondary · At delivery and within first 2 day of life

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

Group	Value	95% CI
Intravenous Insulin Infusion	16
Continuous Subcutaneous Insulin Infusion (CSII)	17

Gestational Age at Delivery Secondary · At birth

Gestational age at delivery

Group	Value	95% CI
Intravenous Insulin Infusion	35.6	± 3.6
Continuous Subcutaneous Insulin Infusion (CSII)	36.0	± 2.8

Number of Participants With Neonatal Respiratory Distress Secondary · At delivery

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

Group	Value	95% CI
Intravenous Insulin Infusion	4
Continuous Subcutaneous Insulin Infusion (CSII)	2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Insulin

Trials testing the same drug.

NCT07460336 — Effects of Cofrogliptin on Beta-Cell Function in LADA Patients · NA · not yet recruiting
NCT07259564 — A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD) · Phase 2 · not yet recruiting
NCT06762314 — Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes · Phase 2 · recruiting
NCT06781775 — GDM: Insulin with or Without Metformin? · Phase 4 · recruiting
NCT06391853 — Investigating Brain Insulin Resistance in Alzheimer Disease with IntraNasal Insulin : a Multimodal Neuroimaging Study · NA · withdrawn

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting

Other Gianna Wilkie trials

Trials by the same sponsor.

NCT04523363 — Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04599075 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gianna Wilkie
Last refreshed: 8 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04599075.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing