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

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

Tracking Information
First Submitted Date  ICMJE June 5, 2020
First Posted Date  ICMJE June 11, 2020
Last Update Posted Date September 30, 2022
Actual Study Start Date  ICMJE September 15, 2022
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: June 9, 2020)
Glycemic Control [ Time Frame: Months 1-12 after enrollment ]
The time-weighted average of Hemoglobin A1C values
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2022)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2020)
180
Estimated Study Completion Date  ICMJE January 1, 2024
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04428658
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party University of California, Davis
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Davis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP