What side effects are associated with this type of intervention?

The most common treatments for Type 1 Diabetes include insulin therapy and continuous glucose monitoring (CGM). Insulin therapy, essential for managing blood glucose levels, can cause side effects such as hypoglycemia (low blood sugar), weight gain, and injection site reactions. Continuous glucose monitoring, which helps track glucose levels in real-time, may lead to skin irritation or discomfort at the sensor insertion site. Both treatments are crucial for managing T1D but require careful monitoring to minimize adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 1 Diabetes, including insulin therapies and advanced insulin delivery systems. Notably, hybrid closed-loop (HCL) insulin delivery systems, which automatically adjust insulin delivery based on continuous glucose monitoring, have been approved and are shown to improve glycemic control and quality of life. While the REDCHiP trial focuses on a video-based telemedicine intervention to reduce parental stress and improve glycemic outcomes in children, it complements these FDA-approved treatments by addressing the emotional and psychological aspects of managing Type 1 Diabetes.

What other types of research exist?

Promising alternatives to REDCHiP for Type 1 Diabetes patients include hybrid closed-loop (HCL) insulin delivery systems, which automatically adjust insulin delivery based on continuous glucose monitoring. These systems have shown to modestly improve glycemic control and quality of life. Additionally, other telemedicine interventions focusing on diabetes self-management and education, such as mobile app-based platforms, have demonstrated efficacy in improving glycemic outcomes and reducing parental stress.

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Telemedicine Intervention for Type 1 Diabetes (REDCHiP Trial)

N/A

Waitlist Available

Led By Susana Patton, PhD, CDE

Research Sponsored by Nemours Children's Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child age between 2-6.99 years

Child age between 2-5.99 years

Must not have

Children with a comorbid chronic condition (e.g., renal disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to post-treatment (week 14)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this trial involves behavioral interventions through telemedicine rather than medication or invasive procedures, there are no direct medical side effects associated with REDCHiP or ATTN.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 2 and almost 7 years old.

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My child is between 2 and 6 years old.

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

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I have been diagnosed with Type 1 diabetes for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to post-treatment (week 14)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to post-treatment (week 14)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-treatment (week 14) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child Glycemic Control

Parents Hypoglycemia Fear

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: REDCHiP intervention armExperimental Treatment1 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 armActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

REDCHiP

2015

N/A

~50

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Type 1 Diabetes (T1D) include insulin therapy, continuous glucose monitors (CGMs), and insulin pumps. Insulin therapy involves administering insulin to manage blood glucose levels, as T1D patients cannot produce insulin. CGMs provide real-time glucose monitoring, aiding in timely insulin adjustments. Insulin pumps deliver continuous insulin, mimicking natural insulin release. These treatments are essential for maintaining glycemic control and minimizing hypoglycemia risk, which is crucial for reducing emotional distress in parents of young T1D patients, as studied in the REDCHiP trial.

The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).A Technological Revolution: The Integration of New Treatments to Manage Type 1 Diabetes.Pump It Up! A randomized clinical trial to optimize insulin pump self-management behaviors in adolescents with type 1 diabetes.