Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes

• ClinicalTrials.gov Identifier: NCT04428658
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: September 30, 2022
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Tracking Information

• First Submitted Date: June 5, 2020
• First Posted Date: June 11, 2020
• Last Update Posted Date: September 30, 2022
• Actual Study Start Date: September 15, 2022
• Estimated Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2022)

Glycemic control [ Time Frame: 6 months - baseline to study completion ]

Mean change in Hemoglobin A1C from enrollment to study completion

Original Primary Outcome Measures (submitted: June 9, 2020)

Glycemic Control [ Time Frame: Months 1-12 after enrollment ]

The time-weighted average of Hemoglobin A1C values

Current Secondary Outcome Measures (submitted: June 21, 2022)

• Healthcare utilization [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: June 9, 2020)

• Glycemic Control [ Time Frame: Months 1-6 after enrollment ]
  The time-weighted average of Hemoglobin A1C values
• Glycemic Control [ Time Frame: Months 7-12 after enrollment ]
  The time-weighted average of Hemoglobin A1C values
• Healthcare utilization [ Time Frame: During the 12 months prior to enrollment ]
  Dates of encounters of the following types will be extracted from participants' medical records: diabetes clinic visits and video visits, ED visits, hospitalizations, and phone or "MyChart" (electronic messaging) encounters with the diabetes team
• Healthcare utilization [ Time Frame: During the 12 months after enrollment ]
  Dates of encounters of the following types will be extracted from participants' medical records: diabetes clinic visits and video visits, ED visits, hospitalizations, and phone or "MyChart" (electronic messaging) encounters with the diabetes team
• Use of diabetes technology [ Time Frame: through study completion, an average of 1 year ]
  Whether or not a patient utilized an insulin pump
• Use of diabetes technology [ Time Frame: through study completion, an average of 1 year ]
  Whether or not a patient utilized a continuous glucose monitor
• Patient experience survey [ Time Frame: Every 12 weeks up to 52 weeks ]
  Surveys asking about the patient's experience with care

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
• Official Title: Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diabetes Mellitus, Type 1

Intervention

• 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.
• Behavioral: Supplemental remote monitoring
  Receiving remote glucose monitoring with monthly outreach from a pediatric endocrinologist as a supplement to regular diabetes clinic visits.

Study Arms

• 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.
  Interventions:

  • Behavioral: Supplemental video visits
  • Behavioral: Standard of Care
• Active Comparator: Standard of Care
  The control group will receive usual care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic.
  Intervention: Behavioral: Standard of Care
• 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.
  Interventions:

  • Behavioral: Standard of Care
  • Behavioral: Supplemental remote monitoring

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 21, 2022): 100
• Original Estimated Enrollment (submitted: June 9, 2020): 180
• Estimated Study Completion Date: January 1, 2024
• Estimated Primary Completion Date: January 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. age 5-18 years
2. diagnosis of type 1 diabetes with a duration of >12 months
3. 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
4. intention to receive diabetes care at the UCD Pediatric Diabetes Clinic during the following year
5. access to the internet via a device with video and audio capability
6. 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04428658
• Other Study ID Numbers: 1616262
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, Davis
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, Davis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of California, Davis
• Verification Date: September 2022