What side effects are associated with this type of intervention?

Common treatments for Type 1 Diabetes, such as insulin therapy and structured education programs, have known side effects. Insulin therapy, including multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII), can cause hypoglycemia, weight gain, and injection site reactions. Structured education programs, like Dose Adjustment for Normal Eating (DAFNE), aim to improve glycemic control and quality of life but may initially cause anxiety or stress as patients adapt to new management strategies.

What prior FDA approvals exist?

The FDA has approved various treatments for Type 1 Diabetes, primarily focusing on insulin therapies and adjunctive treatments to improve glycemic control. While specific digital tools for improving diabetes self-efficacy in Type 1 Diabetes are still under study, the FDA has approved several eHealth and digital therapeutic tools for other conditions, such as ADHD, which may pave the way for similar approvals in diabetes care. These tools aim to enhance patient engagement and self-management, potentially improving outcomes in chronic disease management.

What other types of research exist?

Promising alternatives to eHealth digital tools for Type 1 Diabetes patients in 2024 include: 1) Mobile apps for diabetes management, which offer features like blood glucose tracking, carbohydrate counting, and personalized feedback. 2) Telemedicine, providing remote consultations and continuous support from healthcare providers. 3) Continuous Glucose Monitoring (CGM) systems, offering real-time glucose readings and trend analysis. 4) Hybrid closed-loop insulin delivery systems, which automate insulin delivery based on CGM data, improving glycemic control and reducing the burden of diabetes management.

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Behavioural Intervention

Digital Health Management Tool for Type 1 Diabetes (KiT Trial)

N/A

Recruiting

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

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

Must have

Proficient in written and spoken English or French

Possession of their own personal mobile device that can support SMS with sufficient capacity to send and receive SMS/texts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a digital tool that sends personalized text messages to help young adults manage their type 1 diabetes as they move to adult care. The tool provides support, education, and resources through SMS. It also collects feedback to measure its effectiveness.

Who is the study for?

This trial is for young adults with Type 1 Diabetes who are transitioning to adult care. They must be within 6 months of turning 18 or transferring care, willing to complete questionnaires, and proficient in English or French. Participants need a mobile device capable of SMS and an email address. Those with intellectual disabilities affecting diabetes care or enrolled in other SMS-based trials can't join.

What is being tested?

The study tests an eHealth tool designed to help improve self-care in managing Type 1 Diabetes during the transition from pediatric to adult healthcare services. The effectiveness will be measured through questionnaires at baseline, six months, and twelve months after starting the use of the digital tool.

What are the potential side effects?

Since this trial involves an eHealth digital tool rather than medication, traditional side effects are not expected. However, participants may experience issues related to technology use such as eye strain or stress due to constant health monitoring.

Eligibility Criteria

Inclusion Criteria

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

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I am proficient in English or French.

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I own a mobile device capable of sending and receiving texts.

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I am getting outpatient care for Type 1 Diabetes at a center involved in this study.

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I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To test the effect of a text message-based T1D transition intervention compared to control at 12 months in the Self-Efficacy for Diabetes management scale. A higher score indicates better self-efficacy.

Secondary study objectives

Compare text message-based T1D transition intervention to control at 6 months in the Self-Efficacy for Diabetes management scale. Higher score indicates better self efficacy.

Evaluate the impact of this text message-based intervention compared to usual care at 12 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale

Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values

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Other study objectives

Evaluation of intervention fidelity

Evaluation of participant engagement with the intervention looking at which types of messages are the most and least engaged with

Evaluation of participant engagement with the intervention with number of participants who are engaging with intervention messages

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: eHealth ToolExperimental Treatment1 Intervention

The Intervention is a text messaging algorithm that will operate like a chatbot, querying adolescents with T1D about their confidence with different aspects of T1D self-management as they are preparing to transition to adult diabetes care. The intervention has 4 components of messaging: personalized Educational Content, Standard Educational Curriculum, Provide participant compensation for filling out the questionnaires, Question \& Answer feature.

Group II: ControlActive Control1 Intervention

Participants randomized to the control arm will also be offered the same incentives to complete questionnaires (outcome measures) but will not receive any other components of the intervention - no personalized/customized support or diabetes resource messages and no reminders. Control arm participants will continue with their usual T1D transition care.

0 / 4Eligibility 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 treatment for Type 1 Diabetes (T1D) is insulin therapy, which compensates for the body's inability to produce insulin due to autoimmune destruction of pancreatic beta cells. Insulin therapy involves administering exogenous insulin to regulate blood glucose levels. Additionally, eHealth digital tools, such as smartphone apps, are being studied for their potential to improve diabetes self-efficacy. These tools provide structured education, real-time glucose monitoring, and personalized feedback, helping patients manage their condition more effectively by promoting adherence to treatment regimens and enabling better glycemic control. This is crucial for T1D patients to prevent complications and maintain a better quality of life.

E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial.Effectiveness of lay-led, group-based self-management interventions to improve glycated hemoglobin (HbA1c), self-efficacy, and emergency visit rates among adults with type 2 diabetes: A systematic review and meta-analysis.