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Insulin

Insulin for Type 1 Diabetes

Phase 4
Waitlist Available
Led By Gianna L Wilkie, MD
Research Sponsored by Gianna Wilkie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at birth
Awards & highlights

Study Summary

This trial will compare two methods of insulin delivery for pregnant women with type 1 diabetes, to see if one is better at preventing adverse outcomes for the baby.

Eligible Conditions
  • Type 1 Diabetes
  • Pregnancies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and at birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neonatal Hypoglycemia
Secondary outcome measures
Apgar Score
Development of Diabetic Ketoacidosis during labor
Gestational age at delivery
+19 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intravenous Insulin InfusionExperimental Treatment1 Intervention
Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.
Group II: Continuous Subcutaneous Insulin Infusion (CSII)Experimental Treatment1 Intervention
Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin
2000
Completed Phase 4
~4280

Find a Location

Who is running the clinical trial?

Gianna WilkieLead Sponsor
1 Previous Clinical Trials
240 Total Patients Enrolled
Gianna L Wilkie, MDPrincipal InvestigatorUMass Memorial Health Care
2 Previous Clinical Trials
420 Total Patients Enrolled
~17 spots leftby Jun 2025
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