Telemedicine Intervention for Type 1 Diabetes

(REDCHiP Trial)

Recruiting at 2 trial locations

Overseen By Amy Milkes

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Must be taking: Insulin

Disqualifiers: Conventional regimen, Allergy, Chronic condition, others

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

Compensation: Varies

Number of Visits: 11

Duration: 14 weeks

396 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a video call program called REDCHiP that helps parents of young children with type 1 diabetes manage their fear of low blood sugar events. The program includes therapy, education, and practical training to reduce parental stress and improve the child's blood sugar control. The REDCHiP program is a new video-based telehealth intervention designed to reduce hypoglycemia fear and parenting stress, and it has shown significant reductions in child glycated hemoglobin for children who entered the treatment above target.

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 focuses on a telemedicine intervention for managing stress and diabetes in children.

Is the telemedicine intervention for type 1 diabetes safe for humans?

The telemedicine intervention for type 1 diabetes has been studied in various trials, including one for parents of young children with diabetes, which showed high satisfaction and feasibility. No major safety concerns were reported in these studies, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the REDCHiP treatment for type 1 diabetes differ from other treatments?

The REDCHiP treatment is unique because it uses telemedicine to provide real-time support and communication between patients and their diabetes care team, which can improve blood sugar control by allowing for timely adjustments in insulin dosing and personalized feedback. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment ATTN, REDCHiP for type 1 diabetes?

Research shows that telemedicine support can help people with type 1 diabetes manage their blood sugar levels better. For example, studies found that using telemedicine with tools like insulin dose adjustment software improved blood sugar control in patients. ^{2 6 10 11 12}

Who Is on the Research Team?

Susana Patton, PhD, CDE

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for parents of young children aged 2-6.99 years with Type 1 diabetes on an intensive insulin regimen for at least 6 months. It excludes those whose children have other chronic conditions, are not on such a regimen, or have allergies to glucose monitoring adhesives.

Inclusion Criteria

My child is between 2 and almost 7 years old.

My child is between 2 and 6 years old.

My child uses an insulin pump or gets several insulin shots daily.

Exclusion Criteria

My child has a long-term health condition like kidney disease.

Parents of children using a regular treatment plan.

Kids who are allergic to the stick-on and skin prep for constant sugar monitoring.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 video-based telemedicine sessions, focusing on T1D education and behavioral parent training

14 weeks

10 sessions (virtual)

Post-treatment Assessment

Parents and children repeat baseline assessments to evaluate changes in FH, parenting stress, and children's HbA1c

1 week

Follow-up

Participants are monitored for maintenance of treatment effects on FH, parenting stress, and child HbA1c

3 months

1 follow-up assessment (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ATTN
• REDCHiP

Trial Overview The study tests REDCHiP, a video-based telemedicine intervention aimed at reducing parental fear of hypoglycemia and stress, against ATTN (an attention control). It measures the impact on parents' stress levels and children's HbA1c both after treatment and at a 3-month follow-up.

How Is the Trial Designed?

Group I: REDCHiP intervention arm Experimental Treatment 1 Intervention

REDCHiP uses 10- video-based telemedicine sessions to deliver T1D education, behavioral parent training, and problem-solving to enhance parents' knowledge and skills. Sessions last about 45-60 minutes each.

Group II: Attention Control arm Active Control 1 Intervention

ATTN uses 10- video-based telemedicine sessions to deliver general patient education specific to young children. Similar to REDCHiP, all ATTN sessions last 45-60 minutes.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Children's Mercy Hospital Kansas City

Collaborator

Trials

261

Recruited

941,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

The Diabeo software, which allows for personalized insulin dose adjustments and includes telemedicine support, significantly reduced HbA1c levels in poorly controlled type 1 diabetes patients, achieving a mean HbA1c of 8.41% compared to 9.10% in the usual care group.

Patients using the Diabeo system experienced a 0.91% improvement in HbA1c over controls without an increase in hypoglycemic episodes or additional medical time, making it a cost-effective option for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Charpentier, G., Benhamou, PY., Dardari, D., et al.[2022]

The Diabetes Research in Children Network (DirecNet) has conducted extensive research on type 1 diabetes since 2001, resulting in 28 published studies that evaluate various diabetes management technologies, including glucose meters and continuous glucose monitoring systems.

The network's research also focuses on factors affecting hypoglycemia, such as exercise and diet, and provides valuable data sets and psychosocial questionnaires to the public, enhancing the understanding and management of type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes research in children network:availability of protocol data sets. Ruedy, KJ., Beck, RW., Xing, D., et al.[2023]

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]

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]

Citations

1. United States 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). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Home Telemedicine (CoYoT1 Clinic): A Novel Approach to Improve Psychosocial Outcomes in Young Adults With Diabetes. [2020]

4. Denmark pubmed.ncbi.nlm.nih.gov

Population-level management of type 1 diabetes via continuous glucose monitoring and algorithm-enabled patient prioritization: Precision health meets population health. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing a telemedicine therapeutic intervention with routine care in adults with type 1 diabetes mellitus treated by insulin pumps. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetes research in children network:availability of protocol data sets. [2023]

7. United States 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Telemedicine in paediatric patients with poorly controlled type 1 diabetes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

School-centered telemedicine for children with type 1 diabetes mellitus. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Telemedicine for the Management of Glycemic Control and Clinical Outcomes of Type 1 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. [2022]