A1Control App for Diabetes Management in Youth

No longer recruiting at 1 trial location

Overseen By Sandra Solove, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must be taking: Insulin

Disqualifiers: Learning disability, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new app called A1Control, designed to help young people manage type 1 diabetes more effectively. Researchers will test the app over 12 weeks to evaluate its performance in everyday home settings. The trial seeks participants aged 10 to 18 who have had type 1 diabetes for over a year and currently use an insulin pump or hybrid closed-loop (HCL) therapy. Participants will use the app to determine if it simplifies and enhances diabetes management. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management solutions.

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 prior data suggests that the A1Control app is safe for youth?

Research has shown that smartphone apps for managing diabetes, such as A1Control, are generally safe. Studies have found that these apps do not increase episodes of low blood sugar. Although specific safety data for the A1Control app is not available, similar apps have been well-received without an increase in negative effects. This suggests that A1Control is likely safe for young people managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the A1Control app for diabetes management in youth because it offers a modern, tech-driven approach to managing diabetes, unlike traditional methods like insulin therapy and glucose monitoring devices. The app is designed to help young people track their blood sugar levels, dietary intake, and physical activity seamlessly through their smartphones. This integration of technology into daily diabetes management has the potential to make it easier and more engaging for young users to maintain their health, leading to better outcomes and a more personalized healthcare experience.

What evidence suggests that the A1Control app is effective for diabetes management in youth?

Research has shown that the A1Control app, which all participants in this trial will use, may help young people manage their diabetes. One study found that users of the app improved their blood sugar control by 15.8%, compared to a 10.4% improvement in those who didn't use the app. This suggests the app might enhance blood sugar levels more effectively than standard care alone. Other research indicates that regularly using similar diabetes management apps is linked to better blood sugar control in everyday life. However, some studies have not shown a significant drop in blood sugar levels, so results can vary. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: All Participants Experimental Treatment 1 Intervention

All participants will perform the same study activities

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The smartphone-based automated insulin delivery (AID) system was found to be safe for use in 20 pediatric participants with type 1 diabetes, with minimal instances of low blood glucose and no adverse events reported during a 48-hour trial.

The AID system maintained a similar percentage of time in the target glucose range compared to traditional sensor-augmented pump therapy, while also showing improved overnight glucose stability, indicating its efficacy in managing blood sugar levels in children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes. Deshpande, S., Weinzimer, SA., Gibbons, K., et al.[2022]

A meta-analysis of nine randomized controlled trials involving 748 young patients with type 1 diabetes found that smartphone apps combined with usual care did not significantly reduce HbA1c levels compared to usual care alone.

However, the analysis revealed that auxiliary-style apps, which include features like insulin or carbohydrate calculators, were effective in significantly lowering HbA1c levels, indicating their potential benefit in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of smartphone apps on glycemic control in young patients with type 1 diabetes: A meta-analysis. Pi, L., Shi, X., Wang, Z., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A mobile application was developed to help adolescents with type 1 diabetes manage their condition as they transition to adulthood, based on their specific care needs and expectations.

In a test with 35 participants aged 16-25, the app received high user satisfaction scores, indicating it effectively supports disease self-management.

NCBI (Pubmed)

pubmed.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. Chiang, YT., Chang, CW., Yu, HY., et al.[2023]

Only 21% of adolescents with type 1 diabetes (T1D) reported using mobile apps for diabetes management, with the majority using them primarily for carbohydrate counting.

App usage was linked to factors such as a shorter duration of diabetes, higher socioeconomic status, and more frequent blood glucose monitoring, indicating that those who are more engaged in their diabetes management are more likely to use these tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Mobile Applications Among Adolescents with Type 1 Diabetes: Results from Diabetes MILES Youth-Australia. Trawley, S., Browne, JL., Hagger, VL., et al.[2018]

Only 17% of adolescents with type 1 diabetes are meeting their glycemic targets, indicating a significant gap in effective self-management despite the use of advanced diabetes technologies like insulin pumps and continuous glucose monitors.

Qualitative interviews with 10 adolescents revealed key themes such as the unpredictability of glucose outcomes and the complexity of diabetes management, highlighting the need for better support and education to improve self-management behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expect the unexpected: Adolescent and pre-teens' experience of diabetes technology self-management. Faulds, ER., Grey, M., Tubbs-Cooley, H., et al.[2022]

The FreeStyle Libre Flash Glucose Monitoring System demonstrated high clinical accuracy in children with type 1 diabetes, with 83.8% of sensor results falling within the most accurate zone (zone A) when compared to capillary blood glucose measurements.

The system was well-accepted by participants and caregivers, with 84.3-100% rating the device favorably, and its accuracy was consistent across various patient factors, making it suitable for a wide range of pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Edge, J., Acerini, C., Campbell, F., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A motivational smartphone app significantly improved glycemic control in adolescents with Type 1 diabetes, leading to a reduction in HbA1c levels from 10.6% to 9.65% after 3 months of use.

Out of 28 participants who completed the study, 22 showed a decrease in HbA1c, indicating that the app effectively encouraged better diabetes management behaviors among the users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone App as Motivational Intervention to Improve Glycemic Control in Adolescents with Type 1 Diabetes. Pramanik, BK., Angelin, JJ., Mathai, VJ., et al.[2022]

In a study of 70 children and adolescents with severe diabetic ketoacidosis (DKA), protocol deviations were found in 82.9% of cases, leading to significant complications such as severe hypokalemia and hypoglycemia.

The development of a mobile application for DKA management showed promise in adhering to treatment protocols, potentially reducing errors and improving patient outcomes compared to standard management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development and Validation of a Mobile Application for Guidance for Management of Severe Diabetic Ketoacidosis. Mendpara, H., Bajpai, A., Patel, R., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10337628/

Effectiveness of a new smartphone application on type 1 ...

The primary study endpoint is the HbA1c level after 3 months' follow-up. Secondary outcomes are number of hypoglycaemic events, diabetes treatment satisfaction ...

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A1Control App for Diabetes Management in Youth

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 ...

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frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1074946/full

Effect of smartphone apps on glycemic control in young ...

The current pooled data analysis did not reveal a significant reduction in HbA1c in young patients with T1D using smartphone apps and usual care ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5495971/

A Mobile App for the Self-Management of Type 1 Diabetes ...

The primary outcome of the study was change in HbA1c (measured in percentage) from baseline to 12 months, between the intervention and control ...

5.

jmir.org

jmir.org/2021/7/e23227/

The Effects of Continuous Usage of a Diabetes ...

Our analysis shows that continuous usage of the diabetes management app is associated with better glycemic control in real-world clinical practice.

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(PDF) Simulation Platform Development for Diabetes and ...

Conclusion: A1Control shows potential to increase access and frequency of self-management and technology education. Additional study is needed ...

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diabetesjournals.org/spectrum/article/34/2/139/32959/Beyond-A1C-A-Practical-Approach-to-Interpreting

Beyond A1C: A Practical Approach to Interpreting and ...

Understanding and managing glycemic variability is important in children and adolescents. Because A1C provides an incomplete picture of day-to- ...