20 Participants Needed

A1Control App for Diabetes Management in Youth

Recruiting at 1 trial location
EF
SS
Overseen BySandra Solove, MA
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but since it involves using a diabetes management app, it's likely you can continue your current treatment.

What data supports the effectiveness of the treatment A1Control for diabetes management in youth?

Research shows that smartphone apps can help young people with type 1 diabetes better manage their blood sugar levels. Apps like bant and Diahome have features such as blood sugar tracking and educational tools, which have been found to improve diabetes management.12345

Is the A1Control App for Diabetes Management in Youth safe for use?

The research does not provide specific safety data for the A1Control App, but a study on a similar smartphone-based system for insulin delivery in adolescents and children with type 1 diabetes found it to be feasible and preliminarily safe.16789

How is the A1Control App treatment for diabetes management in youth different from other treatments?

The A1Control App is unique because it leverages technology to help young people manage their diabetes by providing features like wireless blood glucose reading transfer, alerts for out-of-range blood glucose levels, coaching on how to address these issues, and a point-based incentive system to encourage engagement.1231011

What is the purpose of this trial?

The investigators will conduct a 12-week single group feasibility pilot field study among youth who will use a diabetes technology education application in their natural home environment.

Eligibility Criteria

This trial is for young people aged 10-18 with type 1 diabetes for over a year, who are already using an insulin pump or hybrid closed-loop therapy for at least six months. It's not suitable for those with significant learning disabilities, pregnant individuals, or those unable to read and write in English.

Inclusion Criteria

I use an insulin pump or hybrid closed-loop therapy.
I have been using a pump for treatment for 6 months.
I have been diagnosed with type 1 diabetes for over a year.

Exclusion Criteria

Self-reported pregnancy
Significant learning disability
Inability to read and write English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Youth use a diabetes technology education application in their home environment, with weekly video chat or phone call meetings with research staff

12 weeks
Weekly visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collected from diabetes devices and EHR

4 weeks

Treatment Details

Interventions

  • A1Control
Trial Overview The study is testing the use of a mobile health (mHealth) app designed to educate youth on diabetes technology. Participants will use this app at home over a period of 12 weeks to see how feasible and helpful it is.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment1 Intervention
All participants will perform the same study activities

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Findings from Research

In a 12-month randomized controlled trial involving 92 adolescents with type 1 diabetes, the diabetes self-management app 'bant' did not show significant changes in overall clinical outcomes like HbA1c compared to usual care.
However, for participants using self-monitoring of blood glucose (SMBG) at least 5 times daily, there was a notable improvement in HbA1c by 0.58%, suggesting that increased engagement with the app may enhance glycemic control in this subgroup.
A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial.Goyal, S., Nunn, CA., Rotondi, M., et al.[2023]
The pilot study involving 11 parent-child pairs in phase 1 and 10 pairs in phase 2 found that a mobile diabetes educational tool was highly acceptable and engaging, with participants expressing satisfaction with its layout and activities.
The tool demonstrated feasibility in delivering diabetes self-management education in a clinical setting, indicating potential for improving knowledge and behaviors related to diabetes management among children and their parents.
Testing Usability and Feasibility of a Mobile Educator Tool for Pediatric Diabetes Self-Management: Mixed Methods Pilot Study.Otis, M., Zhu, J., Mustafa-Kutana, SN., et al.[2020]
Using the Diahome smartphone app for diabetes management led to a significant reduction in fasting blood glucose levels among users, from 156 mg/dl to 129 mg/dl, compared to conventional treatment.
App users also showed a greater percentage improvement in HbA1c levels (15.8%) compared to non-app users (10.4%), indicating that the app may enhance glycaemic control in patients with type 2 diabetes.
Improvement in glycaemic control in patients with type 2 diabetes with treatment using an interactive mobile application - A pilot study from India.Raghavan, A., Nanditha, A., Satheesh, K., et al.[2022]

References

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. [2023]
Testing Usability and Feasibility of a Mobile Educator Tool for Pediatric Diabetes Self-Management: Mixed Methods Pilot Study. [2020]
Improvement in glycaemic control in patients with type 2 diabetes with treatment using an interactive mobile application - A pilot study from India. [2022]
Effect of smartphone apps on glycemic control in young patients with type 1 diabetes: A meta-analysis. [2023]
Expect the unexpected: Adolescent and pre-teens' experience of diabetes technology self-management. [2022]
The Use of Mobile Applications Among Adolescents with Type 1 Diabetes: Results from Diabetes MILES Youth-Australia. [2018]
Smartphone App as Motivational Intervention to Improve Glycemic Control in Adolescents with Type 1 Diabetes. [2022]
An alternative sensor-based method for glucose monitoring in children and young people with diabetes. [2022]
Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Developing the "Healthcare CEO App" for patients with type 1 diabetes transitioning from adolescence to young adulthood: A mixed-methods study. [2023]
The Development and Validation of a Mobile Application for Guidance for Management of Severe Diabetic Ketoacidosis. [2022]
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