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NCT04278664 Clinical Trial

Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

Official title:
Effect of Telemedicine on Outcomes in Pregnant Women With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04278664
Other study ID # 1506903391 UA IRB#
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2015
Est. completion date November 2017

Study information
Verified date August 2022
Source Mednax Center for Research, Education, Quality and Safety
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ana Braescu University of Arizona

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c, maternal glycemic control maternal glycemic control during pregnancy as measured by HbA1c first trimester in pregnancy through 6 weeks postpartum
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