Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Supplemental video visits Participants in this intervention arm will receive home-based video visits with a pediatric endocrinologist every month for the duration of 6 months in addition to usual care. |
Behavioral: Supplemental video visits
Receiving home-based video visits with a pediatric endocrinologist monthly as a supplement to regular diabetes clinic visits.
Behavioral: Standard of Care
Usual quarterly visits with the UCD Pediatric Diabetes Clinic.
|
| Active Comparator: Standard of Care The control group will receive usual care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic. |
Behavioral: Standard of Care
Usual quarterly visits with the UCD Pediatric Diabetes Clinic.
|
| Experimental: Supplemental remote monitoring Participants in this intervention arm will receive remote glucose monitoring with monthly asynchronous outreach from a pediatric endocrinologist for a duration of six months in addition to usual care. |
Behavioral: Standard of Care
Usual quarterly visits with the UCD Pediatric Diabetes Clinic.
Behavioral: Supplemental remote monitoring
Receiving remote glucose monitoring with monthly outreach from a pediatric endocrinologist as a supplement to regular diabetes clinic visits.
|
Outcome Measures
Primary Outcome Measures
- Glycemic control [6 months - baseline to study completion]
Mean change in Hemoglobin A1C from enrollment to study completion
Secondary Outcome Measures
- Healthcare utilization [6 months prior to study; 6 months during study]
Dates of encounters of the following types will be extracted from participants' medical records for the 6 months prior to and 6 months during study participation, to evaluate for changes in healthcare utilization: diabetes clinic visits (in-person and telehealth), ED visits, and hospitalizations. Participants' use of diabetes technology - including insulin pumps and CGMs - will also be extracted from the medical record at enrollment and at study completion. In addition, the provider time spent to deliver the telehealth intervention each month will be recorded for participants in the intervention arms in order to facilitate analysis of provider time as a secondary outcome and/or an effect modifier for the primary outcome.
- Patient-reported outcomes [6 months - baseline and study completion]
Validated surveys will be administered to all participants at enrollment and at study completion to assess diabetes distress and self-efficacy in diabetes management. Intervention arm participants will also be surveyed regarding the perceived benefits and burdens of the intervention they received.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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access to the internet via a device with video and audio capability
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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.
Exclusion Criteria:
-Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California-Davis | Sacramento | California | United States | 95817 |
Sponsors and Collaborators
- University of California, Davis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1616262