Status:
WITHDRAWN
Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents With Type 1 Diabetes
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Vivify Health
Conditions:
Diabetes Mellitus
Type 1 Diabetes Mellitus
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values ≥10.0% more tha...
Detailed Description
RPM Software The Remote Patient Monitoring application that will be used for this study was created by Vivify Health. Vivify Health was founded in 2009, and their Remote Care Management platform utili...
Eligibility Criteria
Inclusion
- Age 13-18 years old
- Diagnosed with Type 1 Diabetes Mellitus \>1 year ago with at least one positive diabetes autoantibody
- Patient on multiple daily injections of insulin, with no change to insulin type within the past 3 months
- ≥2 separate HbA1c values (at least 60 days apart) ≥10.0% in the past year, with the most recent HbA1c value ≥10.0%
- English-Speaking (patient and at least 1 parent)
- Patient or parents must own a smart phone or other device compatible with Glooko
Exclusion
- Patients on Continuous Subcutaneous Insulin Infusion
- Diagnosed with Type 2 Diabetes or taking metformin
- Other chronic medical condition that would be likely to affect blood glucose. Exceptions include:
- Hypothyroidism on treatment with normal thyroid function tests
- Asthma with no oral steroids within past 3 months
- Unstable social situation that could compromise diabetes management or study follow-up in the judgment of the investigators
Key Trial Info
Start Date :
April 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03466398
Start Date
April 11 2018
End Date
March 5 2020
Last Update
May 14 2020
Active Locations (1)
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1
Children's Medical Center
Dallas, Texas, United States, 75235