Clinical trial NCT04278664: Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus
Official title: Effect of Telemedicine on Outcomes in Pregnant Women With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Type 1 Diabetes
Pregnancy in Diabetic
Keywords: telemedicine
Type 1 diabetes in pregnancy
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2020-02-20
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Maternal glycemic control in Type I Diabetics during pregnancy will be studied by enrolling patients in two different groups: one will be treated with the current standard of care for a type 1 diabetic pregnancy and the other group will receive the same standard of care in addition to utilizing telemedicine communication of glucose and insulin readings during weeks when there are no recommended physician visits. All participants will be monitored throughout their pregnancy and clinical outcomes will be reviewed upon delivery and a 6-week postpartum visit. This study is important in adding to current literature regarding the role of telemedicine in pregnant type 1 diabetic care as it could potentially lead to changes in the current standard care for pregnant type 1 diabetics.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c, maternal glycemic control
timeFrame: first trimester in pregnancy through 6 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pediatrix
name: C. Kevin Huls, MD
role: PRINCIPAL_INVESTIGATOR
References: