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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months prior to study; 6 months during study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months prior to study; 6 months during study
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
946 Previous Clinical Trials
4,756,056 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You plan to get diabetes care at the UCD Pediatric Diabetes Clinic in the next year.You have had type 1 diabetes for more than 12 months.You must be between 5 and 18 years old.Your blood sugar levels are consistently too high, as shown by a blood test called HbA1c or a device called continuous glucose monitoring (CGM).
Research Study Groups:
This trial has the following groups:- Group 1: Supplemental video visits
- Group 2: Standard of Care
- Group 3: Supplemental remote monitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.