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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK121295 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Florida | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Colorado, Denver | OTHER |
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The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in >50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Journey | Experimental | Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist. |
|
| Enhanced Standard of Care | Active Comparator | Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Journey | Behavioral | Web-based telehealth intervention focused on adherence barriers and problem-solving |
|
| Measure | Description | Time Frame |
|---|---|---|
| Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale | Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers. | 6-month follow-up |
| Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale | Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers. | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | A blood test that measures the average blood sugar levels over the past two to three months. | 6-month follow-up |
| Type 1 Diabetes and Life -Youth Report | Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610-0165 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42176729 | Derived | Modi AC, Mara CA, O'Donnell H, Schmidt M, Kichler JC, Smith LB, Westen SC, Jacobsen L, Corathers SD, Williford DN, Trojanowski PJ, Flynn E, Shaffer ER, Tanner B, Driscoll KA. A Pilot Randomized Controlled Clinical Trial to Improve Adherence Barriers for Adolescents with Type 1 Diabetes. J Pediatr. 2026 May 22;295:115155. doi: 10.1016/j.jpeds.2026.115155. Online ahead of print. |
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The NIDDK Data Repository will serve as the primary data repository for the current proposal.
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The NIDDK Data Repository will serve as the primary data repository for the current proposal. In addition, data sets may also be distributed via clinicaltrials.gov. Should individuals or organizations request the dataset directly from the principal investigators, those requests will be directed to the NIDDK Data repository to retrieve the data.
Per NIDDK guidelines on resource sharing for intervention studies, baseline data will be shared within 2 years after study recruitment is complete or within six months of the publication date of the baseline data, whichever comes first. An analytic dataset for the baseline publication will be provided within 6 months of the publication date (when the publication appears online).
The investigators agree that they will identify where the data will be available and how to access the data in any publications and presentations that the investigators author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. Since the investigators will be using the NIDDK Data Repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
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After participants were consented, there was a screening process. If participants were elevated on the BDA, they were eligible to be randomized. If they were not elevated, they screen failed. Of the 195 participants who were consented, n=13 screen failed and additional n=20 withdrew prior to randomization. Thus, only n=162 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetes Journey | Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist. Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving |
| FG001 | Enhanced Standard of Care | Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website. Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention |
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| Post-Intervention |
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| Follow-up 1 |
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| Follow-up 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetes Journey | Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist. Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale | Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow-up |
|
~9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetes Journey | Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist. Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased suicidal ideation | Psychiatric disorders | Non-systematic Assessment | Increased frequency of suicidal ideation which involved psychiatric hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychological Complications | Psychiatric disorders | Non-systematic Assessment | Elevations on the PHQ-8, symptoms of distress, depression, anxiety, and suicidal ideation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avani Modi, Ph.D. | Cincinnati Children's Hospital Medical Center | 513-636-4864 | avani.modi@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2023 | Sep 19, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2024 | Feb 2, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2023 | Feb 5, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
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Outcome measures are patient-reported and thus masking will not occur at the level of participant, investigator or outcomes assessor.
| Enhanced Standard of Care | Behavioral | General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided. |
|
|
| 6-month follow-up |
| Adherence for Continuous Glucose Monitors | % Time in Range for those on continuous glucose monitors. | 6-month follow-up |
| Adherence | # blood glucose checks per day | 6-month follow-up |
| Adherence for Insulin Pump Users | # carbohydrate entries per day for insulin pump users | 6-month follow-up |
| Adherence to Insulin Boluses | The average of the frequency of insulin boluses delivered per day | 6-month follow-up |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Enhanced Standard of Care | Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website. Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Enhanced Standard of Care | Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website. Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided. |
|
|
| Primary | Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale | Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers. | Posted | Mean | Standard Deviation | score on a scale | 6-month follow-up |
|
|
|
| Secondary | Hemoglobin A1C | A blood test that measures the average blood sugar levels over the past two to three months. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | 6-month follow-up |
|
|
|
| Secondary | Type 1 Diabetes and Life -Youth Report | Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life | Posted | Mean | Standard Deviation | score on a scale | 6-month follow-up |
|
|
|
| Secondary | Adherence for Continuous Glucose Monitors | % Time in Range for those on continuous glucose monitors. | Not Posted | 6-month follow-up | Participants |
| Secondary | Adherence | # blood glucose checks per day | Not Posted | 6-month follow-up | Participants |
| Secondary | Adherence for Insulin Pump Users | # carbohydrate entries per day for insulin pump users | Not Posted | 6-month follow-up | Participants |
| Secondary | Adherence to Insulin Boluses | The average of the frequency of insulin boluses delivered per day | Not Posted | 6-month follow-up | Participants |
| 0 |
| 97 |
| 0 |
| 97 |
| 50 |
| 97 |
| EG001 | Enhanced Standard of Care | Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website. Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided. | 0 | 65 | 1 | 65 | 39 | 65 |
|
|
| Medical complications not related to type 1 diabetes | Injury, poisoning and procedural complications | Non-systematic Assessment | injuries, back pain, dental abcess, broken bones, viral illness, otitis externa |
|
| Medical complications related to type 1 diabetes | Endocrine disorders | Non-systematic Assessment | DKA, accidental insulin overdose, high blood glucuse, hyperglycemia, hypoglycema, ketonuria, cellulitis |
|
| Social complication | Social circumstances | Non-systematic Assessment | Medical Neglect reported to and investigated by DCFS |
|
| Regulatory Issue | Investigations | Non-systematic Assessment | PHI Breach and possible breach |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |