TeKnO T1D App for Type 1 Diabetes

(TeKnO T1D Trial)

Overseen By Brynn Marks

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Must be taking: Insulin

Must not be taking: Other glucose-control

Disqualifiers: Major illnesses, Cognitive limitations, others

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

Compensation: Varies

Number of Visits: Unknown

170 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you or your child are using medications other than insulin to control blood sugar levels, you cannot participate in this trial.

What data supports the effectiveness of the TeKnO T1D: Parents treatment for type 1 diabetes?

Research on similar mobile app interventions, like MyT1DHero, shows that apps designed to improve communication between parents and children with type 1 diabetes can enhance diabetes management and outcomes. Additionally, mobile apps that help with self-management and data review, like bant, have shown promise in supporting better blood glucose control. ^{1 2 3 4 5}

Is the TeKnO T1D App safe for humans?

There is no specific safety data available for the TeKnO T1D App itself, but related studies on diabetes technology, like the Omnipod 5 System, showed no serious device-related adverse events, severe low blood sugar, or diabetic ketoacidosis in children and adults with type 1 diabetes. ^{2 6 7 8 9}

How does the TeKnO T1D App treatment for Type 1 Diabetes differ from other treatments?

The TeKnO T1D App treatment is unique because it focuses on supporting parents of children with Type 1 Diabetes through a mobile app, enhancing communication and management of the condition. Unlike traditional treatments that focus on insulin delivery, this app aims to improve family dynamics and support through digital tools, making it a novel approach in diabetes care. ^{1 4 8 10 11}

What is the purpose of this trial?

This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.

Research Team

Brynn Marks, MD, MSHPEd

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for parents of children aged 8-12 with Type 1 Diabetes who use an insulin pump and CGM. The child must have been diagnosed at least 6 months ago, and the parent should be the primary caregiver. Parents or children with significant cognitive issues, major psychiatric disorders, other serious illnesses, or using non-insulin medications for diabetes are excluded.

Inclusion Criteria

The primary caregiver for someone with diabetes cannot participate in the trial.

Your average A1c level has been higher than 7.5% for the past 6 months.

I have been using an insulin pump and CGM for at least a month.

Exclusion Criteria

The child has serious illnesses other than type 1 diabetes.

The child or parent has serious problems with thinking or has major mental health issues.

I use medication other than insulin to manage my diabetes.

Timeline

Semi-structured Interviews

Interviews to better understand existing challenges in diabetes technology educational practices

15 months

Designing an App Delivered Curriculum

Development and beta testing of an educational curriculum using information from interviews

23 months

TeKnO T1D: Parents Pilot Study

Pilot and feasibility study of the newly developed educational curriculum

30 months

Follow-up

Participants are monitored for safety and effectiveness after the curriculum completion

12 weeks

Treatment Details

Interventions

• TeKnO T1D: Parents

Trial Overview The study is developing an app to help parents better manage their child's Type 1 Diabetes by using insulin pumps and CGMs more effectively. It aims to address educational gaps through this technology-based intervention to improve diabetes outcomes.

Participant Groups

Group I: Arm 2: Designing an App Delivered Curriculum Experimental Treatment 1 Intervention

Arm 2 will be conducted from months 10-33 and will use information learned in arm 1 to develop and beta test an educational curriculum. Arm 2 also is not a clinical trial, but is a crucial part of what builds to the clinical trial.

Group II: Arm 3: TeKnO T1D: Parents Pilot Study Active Control 1 Intervention

Arm 3 will be conducted from months 30-60 and involves a pilot and feasibility study of the newly developed educational curriculum. This is the clinical trial.

Group III: Arm 1: Semi-structured Interviews Active Control 1 Intervention

Arm 1 will be conducted from months 0-15 and will use interviews to better understand existing challenges in diabetes technology educational practices. It is not a clinical trial, but is a crucial part of what builds to the clinical trial.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

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]

The investigational advanced hybrid closed-loop system significantly reduced daytime hyperglycemia in adolescents and young adults with type 1 diabetes compared to the MiniMed 670G system, with a mean difference of -3.00% in time spent above 180 mg/dL (p<0.0001).

The advanced hybrid closed-loop system maintained a similar safety profile, showing no increase in severe hypoglycemic events compared to the 670G system, indicating it is a safe alternative for managing blood glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Bergenstal, RM., Nimri, R., Beck, RW., 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]

The use of the AndroidAPS automated insulin delivery system significantly improved glycemic control in young children with type 1 diabetes, with time in range increasing and HbA1c levels decreasing after switching from a sensor-augmented pump.

No severe hypoglycemia or diabetic ketoacidosis (DKA) events were reported during the use of AndroidAPS, indicating a safe profile, along with reported improvements in quality of life for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. Petruzelkova, L., Jiranova, P., Soupal, J., et al.[2022]

The Omnipod 5 automated insulin delivery system significantly improved time in range (TIR) for both children and adults with type 1 diabetes, achieving higher TIR percentages during the hybrid closed-loop phase compared to standard therapy, indicating its effectiveness in managing blood glucose levels.

The study demonstrated that the Omnipod 5 was safe, with no serious device-related adverse events, severe hypoglycemia, or diabetic ketoacidosis reported during the 14-day home use period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes. Forlenza, GP., Buckingham, BA., Brown, SA., et al.[2022]

The open-source automated insulin delivery system, AndroidAPS, demonstrated high safety and feasibility in managing blood glucose levels, maintaining control 95% of the time with only 0.72% of the time spent in hypoglycemia below 3 mmol/L during a study involving 16 adolescents with type 1 diabetes.

The hybrid closed loop (HCL) scenario resulted in a slightly higher time spent in hypoglycemia compared to meal announcement only (MA) and full closed loop (FCL) scenarios, but overall, all methods effectively maintained similar average blood glucose levels, suggesting that FCL could be a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study. Petruzelkova, L., Neuman, V., Plachy, L., et al.[2023]

The Type 1 Doing Well app was found to be feasible and highly acceptable among parents of adolescents with type 1 diabetes, with 91% of parents using it at least twice a week and high satisfaction ratings.

While the app did not show significant differences in clinical outcomes like HbA1c in this pilot study, it has the potential to enhance diabetes management when integrated into a broader intervention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes. Hilliard, ME., Cao, VT., Eshtehardi, SS., et al.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Sugarsquare, a Web-Based Patient Portal for Parents of a Child With Type 1 Diabetes: Multicenter Randomized Controlled Feasibility Trial. [2018]

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

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. [2022]

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

Mobile phone technology for children with type 1 and type 2 diabetes: a parent survey. [2022]

8. Denmark pubmed.ncbi.nlm.nih.gov

Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. [2022]

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

First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes. [2022]

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

First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study. [2023]

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

Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes. [2021]