Telehealth Support for Type 1 Diabetes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Non-California address

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how extra online doctor visits and remote glucose monitoring might help children and teens with type 1 diabetes manage their blood sugar more effectively. Participants will join one of three groups: one with extra video check-ins (home-based video visits), another with remote monitoring (supplemental remote monitoring), and a third receiving regular care (standard of care). It targets those who have had type 1 diabetes for over a year, struggle with blood sugar control, and can connect their diabetes devices to the internet. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current diabetes treatment, as the study focuses on telehealth support rather than medication changes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that telemedicine, which includes video calls and remote monitoring, is generally safe for people with diabetes. Studies have found that telemedicine for diabetes care can save time and money while helping people stay engaged with their treatment plans. Specifically, providing diabetes care through telemedicine has led to high appointment attendance rates.

For remote glucose monitoring, research indicates it can improve blood sugar control for those with diabetes. It is considered safe and is often used to manage blood sugar levels effectively.

Both video visits and remote monitoring have been well-received, with no major problems reported in studies. This indicates they have been safely used by many people without causing significant issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring telehealth support for managing Type 1 Diabetes because it offers a new way to enhance patient care remotely. Unlike the standard of care, which typically involves quarterly in-person visits, one experimental approach includes monthly video visits with a pediatric endocrinologist, potentially improving ongoing patient engagement and support. Another method involves remote glucose monitoring with asynchronous communication, which could provide timely interventions without the need for frequent clinic visits. These telehealth methods aim to improve the quality of care by making it more accessible and consistent, which could lead to better management of diabetes for patients.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

This trial will compare different telehealth approaches for managing type 1 diabetes. Participants in one arm will receive supplemental video visits, which research has shown to be very effective. One study found that 94% of participants were very satisfied with video-based care. Another arm will involve supplemental remote monitoring; studies have shown that checking blood sugar levels from a distance helps manage blood sugar better. Specifically, one study found that real-time continuous glucose monitoring was more effective for controlling blood sugar than other methods. Meanwhile, the control group will receive standard care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Access to the internet via a device with video and audio capability

Exclusion Criteria

Patients whose home addresses are not in California (due to current physician licensing restrictions for telehealth services)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Test-Run and Baseline Data Collection

Participants complete a test-run of remote data-sharing and a home-to-clinic video encounter, followed by baseline data collection

2 weeks

1 visit (virtual)

Treatment

Participants receive either supplemental synchronous video visits or asynchronous remote monitoring for glycemic control over a six-month period

6 months

Monthly visits (virtual) for intervention arms

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-study data collection

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Home-based video visits
• Standard of Care
• Supplemental remote monitoring
• Supplemental video visits

Trial Overview

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.

How Is the Trial Designed?

Group I: Supplemental video visits Experimental Treatment 2 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 monitoring Experimental Treatment 2 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 Care Active Control 1 Intervention

The control group will receive usual care, consisting of quarterly visits with the UCD Pediatric Diabetes Clinic.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

Telehealth is an effective management tool for pediatric and young adult patients with type 1 diabetes, allowing for frequent communication and data sharing with healthcare providers.

Using telehealth improves access to care, enhances appointment adherence, increases patient satisfaction, and boosts overall quality of life for young patients managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Telehealth in Pediatric Type 1 Diabetes Mellitus. Fogel, JL., Raymond, JK.[2020]

A study involving 55 adults with type 1 diabetes found that telehealth (TH) visits were as effective as in-person visits in maintaining glycated hemoglobin (HbA1c) levels after 6 months.

Participants in the TH group experienced significant improvements in glucose metrics, such as time in range and time above range, as well as a better quality of life, while also benefiting from lower costs compared to traditional in-person visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth model versus in-person standard care for persons with type 1 diabetes treated with multiple daily injections: an open-label randomized controlled trial. Ballesta, S., Chillarón, JJ., Inglada, Y., et al.[2023]

In a study of 94 type 1 diabetes patients, those receiving telenursing support showed significantly improved blood glucose levels and reduced HbA1c compared to those receiving standard care, indicating better glycemic control.

The intervention group also demonstrated a higher frequency of self-monitoring of blood glucose, suggesting that telenursing effectively motivates patients to engage more actively in their diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of telenursing in the management of Diabetes Type 1: A randomized controlled trial. Kotsani, K., Antonopoulou, V., Kountouri, A., et al.[2022]

A study involving 214 primary caregivers of pediatric patients with type 1 diabetes showed a satisfactory perception of virtual phone clinics, with an average satisfaction score of 66.71%.

Caregivers who preferred virtual visits and were content with their health status reported higher satisfaction, suggesting that telemedicine can effectively complement in-person care for managing pediatric diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception of primary caregiver toward virtual pediatric clinics for type 1 diabetes mellitus during COVID-19 pandemic in Jeddah, Saudi Arabia: A cross-sectional study. Alzahrani, AM., Magliah, SF., Turkistani, HA., et al.[2022]

Home-based video visits for pediatric patients with poorly controlled type 1 diabetes (T1D) over six months led to a significant reduction in HbA1c levels by an average of 0.8%, indicating improved glycemic control.

Patients reported high satisfaction with the video visit experience, with 94% stating they were 'very satisfied', and the frequency of in-person clinic visits also increased during the study, suggesting enhanced overall care engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based video visits for pediatric patients with poorly controlled type 1 diabetes. Crossen, S., Glaser, N., Sauers-Ford, H., et al.[2022]

Telehealth videoconferencing clinics significantly increased the number of yearly visits for pediatric patients with type 1 diabetes from an average of 1.5 to 2.7 visits, indicating improved access to care.

Despite the increase in visits, glycemic control remained stable, and there were no changes in emergency department visits or hospitalizations, suggesting that telehealth is a safe and effective alternative to in-person visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telehealth Videoconferencing in Pediatric Type 1 Diabetes in Oregon. Guttmann-Bauman, I., Kono, J., Lin, AL., et al.[2022]

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar&#174; in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

A 9-month study involving 93 young adults with type 1 diabetes showed that telemedicine support, including real-time feedback and nurse assistance, led to a significant reduction in median blood glucose levels compared to a control group.

While both groups experienced reductions in HbA1c levels, the difference between the intervention and control groups was not statistically significant, suggesting that additional support for medication and lifestyle adjustments may be necessary for more substantial improvements in glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Farmer, AJ., Gibson, OJ., Dudley, C., et al.[2022]

Patients with type 1 diabetes using telecare (which includes feedback from clinicians) showed a significant reduction in HbA1c levels after 6 months compared to those who only transmitted data without feedback (8.2% vs. 7.8%).

While telecare improved glycemic control, the overall effect was modest, with a meta-analysis indicating a 0.4% difference in HbA1c change compared to control groups, suggesting that while beneficial, telecare may not drastically change outcomes for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Montori, VM., Helgemoe, PK., Guyatt, GH., et al.[2019]

Home-based care for children newly diagnosed with type 1 diabetes resulted in a shorter initial hospital stay (6 days) compared to conventional hospital-based care (9 days), indicating a more efficient approach to treatment.

Both home-based and hospital-based care showed similar levels of glycemic control, diabetes knowledge, and quality of care, suggesting that home-based care is a safe and effective alternative, especially beneficial for families facing socioeconomic challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a new home-based care pathway for children newly diagnosed with type 1 diabetes. Gauche, L., Laporte, R., Bernoux, D., et al.[2023]

A survey of 141 families with pediatric type 1 diabetes showed that both telephone and virtual telehealth visits were highly rated for usability, with telephone visits being easier to learn and understand.

72% of participants expressed a desire for telehealth to continue as part of their future care, indicating a strong preference for remote consultations even after the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of telephone and virtual visits for routine pediatric diabetes care during the COVID-19 pandemic. Fung, A., Irvine, M., Ayub, A., et al.[2022]

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