Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus

Terminated

• Conditions: Pregnancy in Diabetic; Type 1 Diabetes

• Registration Number: NCT04278664
• Lead Sponsor: Ana Braescu

Brief Summary

Hypothesize that co-managing pregnant type 1 diabetics with telemedicine will have at least equivalent outcomes to those managed with standard care. Comparison of outcomes between pregnant type 1 diabetics being co-managed with telemedicine compared to those receiving conventional care will help identify unanswered clinical questions and areas for improvement in regard to standards of care for pregnant type 1 diabetics. The data generated from this analysis will help determine whether telemedicine can be an effective additional means of care for pregnant type 1 diabetic patients.

Detailed Description

Few studies have researched the use of telemedicine in the management of type 1 diabetes during pregnancy. These studies are additionally limited due to the number of patients as well as several secondary outcomes reported. Therefore, this study will enroll 100 participants to reach a power of 81.8% with HbA1c as a primary outcome and secondary outcomes related to diabetic management such as frequency of hypoglycemia, antenatal hospital stay (percentage requiring admission, length of stay), miscarriage, cesarean section rates, induction of labor, fetal birth weight, gestational age at birth or preterm birth (\<34 weeks, \<37 weeks), frequency of neonatal hypoglycemia, shoulder dystocia, neonatal death, major and minor anomalies, and neonatal intensive care admission.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-20
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• type 1 diabetics who are at or less than 16 weeks in their pregnancy
• 18 years of age or more
• Voluntary participation

Exclusion Criteria

• <18 years of age
• Not Type I diabetic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c, maternal glycemic control	first trimester in pregnancy through 6 weeks postpartum	maternal glycemic control during pregnancy as measured by HbA1c