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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

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
Diabetes Mellitus, Type 1 Behavioral: Supplemental video visits Behavioral: Standard of Care Behavioral: Supplemental remote monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Supplemental Synchronous and Asynchronous Telehealth to Improve Glycemic Control for Pediatric Patients With Type 1 Diabetes
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  1. Glycemic control [ Time Frame: 6 months - baseline to study completion ]
    Mean change in Hemoglobin A1C from enrollment to study completion


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428658


Locations
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United States, California
University of California-Davis Recruiting
Sacramento, California, United States, 95817
Contact: Salvador Lopez, BA    916-734-4476    salo@ucdavis.edu   
Contact: Christine Feller RD CCRP, BS, BA       cfeller@ucdavis.edu   
Principal Investigator: Stephanie Crossen, MD, MPH         
Sponsors and Collaborators
University of California, Davis
Additional Information:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04428658    
Other Study ID Numbers: 1616262
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases