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Telehealth Support for Type 1 Diabetes

N/A
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months prior to study; 6 months during study
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if extra video visits and remote monitoring can help kids with uncontrolled type 1 diabetes better manage their blood sugar levels over 6 months, and compare how well these two interventions work compared to usual care.

Who is the study for?
This trial is for kids aged 5-18 with type 1 diabetes who've had it for over a year. They need to have high blood sugar levels and be able to get online care at the UCD Pediatric Diabetes Clinic in California. They can't join if they don't live in California.
What is being tested?
The study looks at whether extra video visits or remote monitoring help control blood sugar better than usual care alone, over six months, for young patients with poorly controlled type 1 diabetes.
What are the potential side effects?
Since this trial involves standard care and additional telehealth services rather than medication, there are no direct side effects from treatments like you'd expect with drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months prior to study; 6 months during study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months prior to study; 6 months during study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glycemic control
Secondary study objectives
Healthcare utilization
Patient-reported outcomes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Supplemental video visitsExperimental Treatment2 Interventions
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.
Group II: Supplemental remote monitoringExperimental Treatment2 Interventions
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.
Group III: Standard of CareActive Control1 Intervention
The control group will receive usual care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,755,606 Total Patients Enrolled

Media Library

Standard of Care Clinical Trial Eligibility Overview. Trial Name: NCT04428658 — N/A
Type 1 Diabetes Research Study Groups: Supplemental video visits, Standard of Care, Supplemental remote monitoring
Type 1 Diabetes Clinical Trial 2023: Standard of Care Highlights & Side Effects. Trial Name: NCT04428658 — N/A
Standard of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04428658 — N/A
~3 spots leftby Jan 2025
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