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Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04278664
Enrollment
5
Registered
2020-02-20
Start date
2015-07-31
Completion date
2017-11-30
Last updated
2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy in Diabetic, Type 1 Diabetes

Keywords

telemedicine, Type 1 diabetes in pregnancy

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.

Interventions

None listed

Sponsors

University of Arizona
CollaboratorOTHER
Ana Braescu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1c, maternal glycemic controlfirst trimester in pregnancy through 6 weeks postpartummaternal glycemic control during pregnancy as measured by HbA1c

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026