Telemedicine in Pregnant Women With Type 1 Diabetes Mellitus

NCT04278664 | Terminated

• 1 other identifier: 1506903391 UA IRB#
• Study Type: observational
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes; Pregnancy in Diabetic

Keywords

telemedicine; Type 1 diabetes in pregnancy

Outcome Measures

Primary Outcomes (1)

• HbA1c, maternal glycemic control

  maternal glycemic control during pregnancy as measured by HbA1c

  first trimester in pregnancy through 6 weeks postpartum

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \<18 years of age
• Not Type I diabetic

Sponsors & Collaborators

• Ana Braescu: lead
• University of Arizona: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• C. Kevin Huls, MD

  Pediatrix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: July 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share