What this study is
This study will test the hypothesis that supplemental synchronous video visits and supplemental asynchronous remote monitoring can each significantly improve glycemic control for pediatric patients with uncontrolled type 1 diabetes over a 6 month period, and will compare health outcomes and patient-centered outcomes between these two intervention arms and a control arm receiving usual care.
What's being tested
- Supplemental video visits
Intervention · BEHAVIORAL
Receiving home-based video visits with a pediatric endocrinologist monthly as a supplement to regular diabetes clinic visits.
- Standard of Care
Intervention · BEHAVIORAL
Usual quarterly visits with the UCD Pediatric Diabetes Clinic.
- Supplemental remote monitoring
Intervention · BEHAVIORAL
Receiving remote glucose monitoring with monthly outreach from a pediatric endocrinologist as a supplement to regular diabetes clinic visits.
Study details
- Sponsor
- University of California, Davis
- Conditions
- Diabetes Mellitus, Type 1
- Enrolling
- 82 people
- Starts
- 2022-09-15
- Est. completion
- 2025-07-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 5-18 years
- Diagnosis of type 1 diabetes with a duration of >12 months
- Suboptimal glycemic control at time of enrollment, defined as a hemoglobin A1c (HbA1c) level > 8% (64 mmol/mol) or a 14-day glucose management index (GMI) of >8% from continuous glucose monitoring (CGM) data or 14-day average blood glucose of >200 mg/dl in the preceding month
- Intention to receive diabetes care at the UCD Pediatric Diabetes Clinic during the following year
- Access to the internet via a device with video and audio capability
- Ability to connect the patient's home blood glucose meter or CGM device - as well as insulin pump, if applicable - to an internet-capable device via Bluetooth or physical cable.
You can't join if
- Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California-Davis
Sacramento, California, United States
- Salvador Lopez, BA · Contact916-734-4476salo@ucdavis.edu
- Christine Feller RD CCRP, BS, BA · Contactcfeller@ucdavis.edu
- Stephanie Crossen, MD, MPH · Principal investigator
Recruiting
Study team
Sponsor
University of California, Davis
Study ID 1616262
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.