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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| Tandem Diabetes Care, Inc. | INDUSTRY |
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This project focuses on embedding the participants' own diabetes data into state-of-the-art technology platforms to constitute a novel educational simulation interface for decision-support in Type 1 Diabetes (T1D) - the Web-based Simulation Tool (WST).
The Web-based Simulation Tool (WST) allows patients with Type 1 Diabetes (T1D) to not only visualize their data, but also to explore changes to their meals and insulin parameters, and easily estimate their potential clinical impact. WST is an educational tool, and as such, it does not have prescriptive power. This platform collects glucose, insulin and meal data from the participants' insulin pump, and generates personalized models of their glucose metabolism. Both data collection and model personalization are backend processes, that is, without user intervention.
Participants can interact with WST through a user interface (UI) that is equipped with a dashboard page, where they can:
(i) select a particular date range using a calendar to visualize their historical glucose control, such as glucose traces, and time in range;
(ii) control the amount of information on the screen - users can show/hide more details, such as glucose variability;
(iii) select different insulin therapy parameters: basal rate, insulin sensitivity factor, and carbohydrate ratio;
(iv) change their values by moving a slider;
(v) select informed meals within the selected date range, and modify their time and size by moving a slider;
(vi) run a simulation with the modified insulin therapy parameters and meals by tapping a button;
(vii) save the insulin and meal settings of the simulations to compare multiple configurations; and
(viii) generate a report from the selected simulation, comparing both original and simulated or replay data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based Simulation Tool (WST) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based Simulation Tool | Other | Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations. |
| Measure | Description | Time Frame |
|---|---|---|
| Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention) | Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for burdens and benefits. The original 1-to-5 scale is converted to a 0-to-4 scale, the mean scores for burdens and benefits are averaged and then converted into a percentage ranging from 0% to 100%. Higher percentages mean a better outcome for benefits and a worse outcome for burdens. | Baseline and Week 5 (Post-intervention) |
| Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention) | Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for ease of use, usefulness, and trustworthiness of the system. Higher scores mean a better outcome. | Baseline and Week 5 (Post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress Scale at Baseline and Week 5 (Post-intervention) | The Diabetes Distress Scale (DDS) is a 17-item scale that yields a total diabetes distress score plus 4 subscale scores: Emotional burden (5 items), regimen distress (5 items), interpersonal distress (3 items) and physician distress (4 items). Scores range from 1 to 6 (from Not a problem to A very serious problem). To compute the total diabetes distress score and the 4 subscale scores, participants' responses in each scale are summed and divided by the corresponding number of items. A mean item score lower than 2.0 is considered little or no distress, between 2.0 and 2.9 is considered moderate distress, and higher than 3.0 is considered high distress. Thus, higher scores mean a worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Potential Correlation Between System Use and Changes in the Percentage of Time Spent in 70-180 mg/dL Between First Week (Observation) and Following 4 Weeks (Intervention) | The percentage of time spent in 70-180 mg/dL (time in range, TIR) is computed per participant on a weekly basis (1 week of observation, 4 weeks of intervention) using glucose sensor data. The higher the TIR the better the glucose control. Percentages during the intervention period are averaged per participant, thus obtaining 2 TIRs for each participant (one Observation TIR and one Intervention TIR). A linear regression analysis is performed to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in TIR between Observation and Intervention periods (response variable). Predictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. Response variable: Intervention TIR - Observation TIR. The higher the response variable the better the outcome. |
Inclusion Criteria:
Exclusion Criteria:
Participants who are not able to read and complete questionnaires on the computer or interact with a program for which they will be trained because of language, reading, or cognitive issues.
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
History of a seizure disorder (except hypoglycemic seizure), unless written clearance is received from a neurologist and not currently on a seizure medication.
Pregnancy, breast-feeding, or intention of becoming pregnant over time of study procedures.
If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.
A known medical condition that in the judgment of the investigator might interfere with the completion of the study.*
Abuse of alcohol or recreational drugs.
Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, etc).
Uncontrolled arterial hypertension (resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg).
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
Current use of the following drugs and supplements:
Any drug other than insulin to treat diabetes.
Any other medication that according to the investigator's criteria is a contraindication for the subject's participation.
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| Name | Affiliation | Role |
|---|---|---|
| Patricio Colmegna, PhD | University of Virginia, Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia - Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36149995 | Background | Colmegna P, Bisio A, McFadden R, Wakeman C, Oliveri MC, Nass R, Breton M. Evaluation of a Web-Based Simulation Tool for Self-Management Support in Type 1 Diabetes: A Pilot Study. IEEE J Biomed Health Inform. 2023 Jan;27(1):515-525. doi: 10.1109/JBHI.2022.3209090. Epub 2023 Jan 4. | |
| 38662425 | Result | Colmegna P, McFadden R, Fabris C, Lobo B, Nass R, Oliveri MC, Brown SA, Kovatchev B. Adaptive Biobehavioral Control: A Pilot Analysis of Human-Machine Coadaptation in Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):644-651. doi: 10.1089/dia.2023.0399. Epub 2024 Apr 30. |
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No plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Web-based Simulation Tool (WST) | Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Web-based Simulation Tool (WST) | Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations. |
| 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 | Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention) | Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for burdens and benefits. The original 1-to-5 scale is converted to a 0-to-4 scale, the mean scores for burdens and benefits are averaged and then converted into a percentage ranging from 0% to 100%. Higher percentages mean a better outcome for benefits and a worse outcome for burdens. | Posted | Median | Inter-Quartile Range | percentage of mean item score | Baseline and Week 5 (Post-intervention) |
|
5 weeks
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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 | Web-based Simulation Tool (WST) | Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID positive | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
The Tandem t:connect web application was down for one month due to maintenance work, affecting considerably 4 participants who did not have the opportunity to interact with up-to-date data during a significant part of Phase 2 (system-use phase).
No data was excluded in computing the outcomes, despite this issue (and the COVID positive case).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricio Colmegna, PhD | University of Virginia Center for Diabetes Technology | 434-924-5592 | pc2jx@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2020 | Feb 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2020 | Feb 10, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single-arm, single center, non-randomized, uncontrolled pilot clinical trial
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| Baseline and Week 5 (Post-intervention) |
| First Week (Observation) and Following 4 Weeks (Intervention) |
| Potential Correlation Between System Use and Changes in Perceived Regimen Distress at Baseline and Week 5 (Post-intervention) | Perceived regimen distress is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to A very serious problem). Participants' responses to the DSS's regimen distress items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable). Predictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. Response variable: Regimen distress score at week 5 - Regimen distress score at baseline. The higher the response variable the worse. | Baseline and Week 5 (Post-intervention) |
| Potential Correlation Between System Use and Changes in Perceived Emotional Burden at Baseline and Week 5 (Post-intervention) | Perceived emotional burden is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to a very serious problem). Participants' responses to the DSS's emotional burden items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable). Predictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. Response variable: Emotional burden score at week 5 - Emotional burden score at baseline. The higher the response variable the worse. | Baseline and Week 5 (Post-intervention) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hemoglobin A1c | 1 participant did not meet inclusion criteria, and 2 participants withdrew for scheduling purposes prior to Hemoglobin A1c measurement. | Mean | Standard Deviation | Percentage of glycosylated hemoglobin |
|
| OG000 | Web-based Simulation Tool (WST) | Web-based Simulation Tool: Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations. |
|
|
| Primary | Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention) | Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are made of 27 items. Responses to the TE questionnaire were collected at week 0 (baseline), and responses to the TA questionnaire at week 5 (post-intervention). Each questionnaire has 5 categories: burdens (14 items), benefits (10 items), ease of use, usefulness, and trustworthiness (last 3, 1 item each). Items are scored on a 5-point Likert scale ranging from 1 to 5 (from strongly disagree to strongly agree for burdens and benefits, and from very poor to excellent for ease of use, usefulness, and trustworthiness). Here we report the results for ease of use, usefulness, and trustworthiness of the system. Higher scores mean a better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Week 5 (Post-intervention) |
|
|
|
| Secondary | Diabetes Distress Scale at Baseline and Week 5 (Post-intervention) | The Diabetes Distress Scale (DDS) is a 17-item scale that yields a total diabetes distress score plus 4 subscale scores: Emotional burden (5 items), regimen distress (5 items), interpersonal distress (3 items) and physician distress (4 items). Scores range from 1 to 6 (from Not a problem to A very serious problem). To compute the total diabetes distress score and the 4 subscale scores, participants' responses in each scale are summed and divided by the corresponding number of items. A mean item score lower than 2.0 is considered little or no distress, between 2.0 and 2.9 is considered moderate distress, and higher than 3.0 is considered high distress. Thus, higher scores mean a worse outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and Week 5 (Post-intervention) |
|
|
|
| Other Pre-specified | Potential Correlation Between System Use and Changes in the Percentage of Time Spent in 70-180 mg/dL Between First Week (Observation) and Following 4 Weeks (Intervention) | The percentage of time spent in 70-180 mg/dL (time in range, TIR) is computed per participant on a weekly basis (1 week of observation, 4 weeks of intervention) using glucose sensor data. The higher the TIR the better the glucose control. Percentages during the intervention period are averaged per participant, thus obtaining 2 TIRs for each participant (one Observation TIR and one Intervention TIR). A linear regression analysis is performed to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in TIR between Observation and Intervention periods (response variable). Predictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. Response variable: Intervention TIR - Observation TIR. The higher the response variable the better the outcome. | Posted | Mean | Standard Deviation | percentage of time | First Week (Observation) and Following 4 Weeks (Intervention) |
|
|
|
|
| Other Pre-specified | Potential Correlation Between System Use and Changes in Perceived Regimen Distress at Baseline and Week 5 (Post-intervention) | Perceived regimen distress is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to A very serious problem). Participants' responses to the DSS's regimen distress items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable). Predictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. Response variable: Regimen distress score at week 5 - Regimen distress score at baseline. The higher the response variable the worse. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 5 (Post-intervention) |
|
|
|
|
| Other Pre-specified | Potential Correlation Between System Use and Changes in Perceived Emotional Burden at Baseline and Week 5 (Post-intervention) | Perceived emotional burden is estimated at Baseline and Week 5 (Post-intervention) using the Diabetes Distress Scale (DDS). Scores range from 1 to 6 (from Not a problem to a very serious problem). Participants' responses to the DSS's emotional burden items are summed and divided by the number of items in that scale. Higher scores mean a worse outcome. Scores at week 5 are compared with scores at baseline and used in a linear regression analysis to infer the impact (if any) of the duration and frequency of participants' interaction with the Web-Based Simulation Tool (predictor variables) on variations in treatment satisfaction (response variable). Predictor variable 1: Number of simulations per participant per week. Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. Response variable: Emotional burden score at week 5 - Emotional burden score at baseline. The higher the response variable the worse. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 5 (Post-intervention) |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| usefulness_Post-intervention |
|
| trustworthiness_Baseline |
|
| trustworthiness_Post-intervention |
|
|
| Emotional-Burden_Post-intervention |
|
| Regimen-Distress_Baseline |
|
| Regimen-Distress_Post-intervention |
|
| Interpersonal-Distress_Baseline |
|
| Interpersonal-Distress_Post-intervention |
|
| Physician-Distress_Baseline |
|
| Physician-Distress_Post-intervention |
|
| Slope |
| -0.68016 |
| Standard Error of the Mean |
| 1.0084 |
| 2-Sided |
Predictor variable 1: Number of simulations per participant per week. |
| Other |
| Regression, Linear | 0.68197 | Slope | 0.15238 | Standard Error of the Mean | 0.3629 | 2-Sided | Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. | Other |
| Slope |
| 0.16785 |
| Standard Error of the Mean |
| 0.11745 |
| 2-Sided |
Predictor variable 1: Number of simulations per participant per week. |
| Other |
| Regression, Linear | 0.17514 | Slope | -0.06091 | Standard Error of the Mean | 0.042266 | 2-Sided | Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. | Other |
| Slope |
| -0.14422 |
| Standard Error of the Mean |
| 0.1581 |
| 2-Sided |
Predictor variable 1: Number of simulations per participant per week. |
| Other |
| Regression, Linear | 0.26057 | Slope | 0.06718 | Standard Error of the Mean | 0.056895 | 2-Sided | Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week. | Other |