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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK113189 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Clinical Directors Network | NETWORK |
| University of Colorado, Denver | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 diabetes (T2DM) to individuals' behavioral and glycemic profiles discovered using computational learning and self-monitoring data. This study is a two-arm randomized controlled trial with n=280 participants recruited from the participating Federally Qualified Health Centers (FQHCs). The participants will be randomly assigned to the intervention group and the usual care (control) group with 1-1 allocation ratio. Half of the participants (n=140) will be randomly assigned to a usual care (control) group. Both groups will receive standard diabetes education at their respective FQHC site. In addition, the experimental group will receive instructions to use T2.coach for a minimum of 6 months.
One of the main difficulties in managing diabetes is that each affected individual requires personally tailored combination of diet, exercise, and medication to effectively control their blood sugar. Rather than strictly following a doctor's prescription, individuals need to carefully examine their lifestyle choices and their impact on their health. Independent learning, experimentation and problem solving become of great importance. However, they can be challenging for individuals with diabetes. In this project, the investigators will refine and evaluate a novel intervention for diabetes self-management that uses computational analysis of self-monitoring data to help individuals with type 2 diabetes identify what daily activities, including consumption of meals, physical activity, and sleep, have impact on blood glucose levels, and suggest modifications to these daily activities to improve blood glucose levels.
Growing evidence highlights significant differences in glycemic function and cultural, social, and economical circumstances of individuals with type 2 diabetes (T2DM) that impact their self-management. Precision medicine strives to personalize medical treatment to an individual's genetic makeup, computationally discovered clinical phenotypes and lifestyle. Studies showed the benefits of tailoring not only medical treatment, but also behavioral interventions. Yet, currently, personalization of self-management in T2DM requires each individual to engage in discovery, reflection, and problem-solving-critical but cognitively demanding activities-or to rely on their healthcare providers. Both of these may present considerable barriers to individuals from medically under-served low income communities. Mobile health (mHealth) solutions in T2DM bring promise of reaching wider populations in need of self-management; however, few such solutions provide assistance with personalizing self-management behaviors. Ongoing efforts on personalizing behavioral interventions outside of T2DM focus on tailoring behavior modification techniques to individuals' psycho-social characteristics, such as self-efficacy ), and tailoring delivery of intervention to individuals' context rather than on personalizing self-management strategies.
The ongoing focus of this research is on developing informatics interventions for diabetes self-management, with a specific focus on discovery with self-monitoring data and on problem-solving for improving glycemic control. In the proposed research the investigators introduce T2.coach, an mHealth intervention that uses computational analysis of self-monitoring data to identify behavioral patterns associated with poor glycemic control and formulate personalized behavioral goals for changing problematic behaviors. This study will evaluate T2.coach's efficacy in a two-arm RCT with stratified randomization conducted with Clinical Directors Network (CDN), a well-recognized primary care practice-based research network (PBRN) of Federally Qualified Health Centers (FQHCs), and Agency for Healthcare Research and Quality (AHRQ)-designated Center of Excellence (P30) for Practice-based Research and Learning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2.coach | Experimental | Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months. |
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| Control | No Intervention | Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2.coach | Behavioral | T2.coach is a smartphone app for low-burden capture of diet and blood glucose (BG) levels and for reviewing past records, integrated with FitBit for captured of physical activity and sleep. All captured data are sent to the computational inference engine that uses machine learning methods and expert system to formulate personalized behavioral goals. Examples of behavioral goals include the following: "For high carbohydrate breakfasts, reduce your carbs to be about 1 carb choice. Examples of 1 carb choice are 1 slice of whole wheat toast, 1 cup of oatmeal, or 1 apple." The T2.coach chatbot companion uses text messages to help individuals set goals that are consistent with evidence based guidelines for diabetes self-management, inferences on data captured with T2.coach, and their own preferences, as well as send individuals goal reminders and prompts for reflection on goal achievement. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean HbA1c Value | The main outcome is the mean Hemoglobin A1c at 12 months. In the statistical analysis, we examine difference in mean HbA1c between the study arms at baseline, 6 months, and 12 months. | Baseline, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| SCA-I Score | Diabetes Self-Care Inventory (SCA-I) is a 15-item 5-point Likert scale (1-never engage; 5-always engage) for measuring different aspects of diabetes self-care. The final score ranges from 1 (lowest) to 5 (highest) with a higher score indicating better self-care (better outcome). To account for missing values, the final score was normalized to a 1-100 scale with a higher score indicating better self-care. All analysis was conducted with normalized scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olena Mamykina, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Directors Network | New York | New York | 10018 | United States | ||
| Columbia University Irving Medical Center |
Due to the sensitive nature of individual participant data (IPD) collected in this study, the dataset will only be made available for other potential users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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7,616 participants were assessed for eligibility. Of these, 4,552 did not meet inclusion criteria, 775 declined to participate, and 1,989 were excluded for other reasons. The remaining 300 met the inclusion criteria, were consented and randomized into study arms. Participants were randomized on an individual level. No units other than participants were randomized.
Recruitment occurred from 2020-2023. Initially, participants were recruited in person at two FQHCs via waiting-room outreach and staff referrals. Recruitment paused in March 2020 due to COVID-19. By August 2020, the study transitioned to fully virtual procedures, expanding to four additional sites. The team used secure EHR access to identify eligible participants and conducted outreach by phone.
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| ID | Title | Description |
|---|---|---|
| FG000 | T2.Coach | Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months. |
| FG001 | Control | Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and FitBit for tracking physical activity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | T2.Coach | Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean HbA1c Value | The main outcome is the mean Hemoglobin A1c at 12 months. In the statistical analysis, we examine difference in mean HbA1c between the study arms at baseline, 6 months, and 12 months. | Posted | Mean | Standard Deviation | % of hemoglobin bound to glucose | Baseline, 6 months, 12 months |
|
1 year
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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 | T2.Coach | Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Non-systematic Assessment | Hospitalization for causes unrelated to the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low blood glucose level | General disorders | Non-systematic Assessment | Low blood glucose level |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lena Mamykina | Columbia University | 2123056827 | lena.mamykina@columbia.edu |
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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 | Oct 14, 2021 | Apr 20, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2021 | Apr 20, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Original consent form | Oct 14, 2021 | Apr 20, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Modified Consent Form (oral script for virtual recruitment) | Oct 14, 2021 | Apr 20, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Two-arm RCT with 1:1 randomization at participant level, with stratified randomization to balance by clinical site, sex, and language, evaluate the efficacy of the T2.coach intervention
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Because of the nature of the intervention (smartphone app), masking is not possible.
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| Baseline, 6 months, 12 months |
| DSES Score | Diabetes Self-Efficacy Scale (DSES) is a 15-item 10-point Likert scale (1-not at all confident; 10-totally confident) that measures the belief that one can self-manage one's own health, adapted to diabetes. Final scores are averaged, and the total score ranges from 1 (lowest) to 10 (highest) with a lower score indicating poor self-efficacy (worse outcome). | Baseline, 6 months, 12 months |
| PAID Score | Problem Areas in Diabetes (PAID) is a 20-item 5-point Likert scale (0=not a problem; 4=very serious problem) that measures the emotional aspect of living with diabetes. The final score ranges from 0 (lowest) to 80 (highest), with a higher score indicating greater emotional discomfort (worse outcome). | Baseline, 6 months, 12 months |
| New York |
| New York |
| 10032 |
| United States |
Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and FitBit for tracking physical activity.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Insurance | A binary measure that groups individuals into 2 categories:
| Count of Participants | Participants |
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| Marital status | The categories include:
| Count of Participants | Participants |
|
| Annual Income | Count of Participants | Participants |
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| Language | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
|
|
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| Secondary | SCA-I Score | Diabetes Self-Care Inventory (SCA-I) is a 15-item 5-point Likert scale (1-never engage; 5-always engage) for measuring different aspects of diabetes self-care. The final score ranges from 1 (lowest) to 5 (highest) with a higher score indicating better self-care (better outcome). To account for missing values, the final score was normalized to a 1-100 scale with a higher score indicating better self-care. All analysis was conducted with normalized scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | DSES Score | Diabetes Self-Efficacy Scale (DSES) is a 15-item 10-point Likert scale (1-not at all confident; 10-totally confident) that measures the belief that one can self-manage one's own health, adapted to diabetes. Final scores are averaged, and the total score ranges from 1 (lowest) to 10 (highest) with a lower score indicating poor self-efficacy (worse outcome). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months |
|
|
|
|
| Secondary | PAID Score | Problem Areas in Diabetes (PAID) is a 20-item 5-point Likert scale (0=not a problem; 4=very serious problem) that measures the emotional aspect of living with diabetes. The final score ranges from 0 (lowest) to 80 (highest), with a higher score indicating greater emotional discomfort (worse outcome). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 12 months |
|
|
|
|
| 3 |
| 148 |
| 4 |
| 148 |
| 1 |
| 148 |
| EG001 | Control | Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center). | 3 | 152 | 4 | 152 | 0 | 152 |
|
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| D004700 | Endocrine System Diseases |
| 12 months |
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| 12 months |
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| 12 months |
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