Trial Outcomes & Findings for Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus (NCT NCT04439903)
NCT ID: NCT04439903
Last Updated: 2024-11-14
Results Overview
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.
COMPLETED
NA
18 participants
Baseline and Week 5 (Post-intervention)
2024-11-14
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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18
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
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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Overall Study
Withdrawal by Subject
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2
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Overall Study
Screen Failure
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1
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Baseline Characteristics
1 participant did not meet inclusion criteria, and 2 participants withdrew for scheduling purposes prior to Hemoglobin A1c measurement.
Baseline characteristics by cohort
| Measure |
Web-based Simulation Tool (WST)
n=18 Participants
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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Age, Continuous
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35 years
STANDARD_DEVIATION 12 • n=18 Participants
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Sex: Female, Male
Female
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12 Participants
n=18 Participants
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Sex: Female, Male
Male
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6 Participants
n=18 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=18 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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18 Participants
n=18 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=18 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=18 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=18 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=18 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=18 Participants
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Race (NIH/OMB)
White
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17 Participants
n=18 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=18 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=18 Participants
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Hemoglobin A1c
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6.5 Percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.7 • n=15 Participants • 1 participant did not meet inclusion criteria, and 2 participants withdrew for scheduling purposes prior to Hemoglobin A1c measurement.
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Web-based Simulation Tool (WST)
n=15 Participants
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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|---|---|
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)
Burdens_Baseline
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25.0 percentage of mean item score
Interval 14.4 to 38.1
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)
Burdens_Post-intervention
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42.5 percentage of mean item score
Interval 21.3 to 51.3
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)
Benefits_Baseline
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58.9 percentage of mean item score
Interval 52.7 to 68.8
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)
Benefits_Post-intervention
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55.4 percentage of mean item score
Interval 38.4 to 66.1
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Web-based Simulation Tool (WST)
n=15 Participants
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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Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
trustworthiness_Post-intervention
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4 score on a scale
Interval 3.0 to 4.0
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
ease-of-use_Baseline
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4 score on a scale
Interval 3.0 to 4.0
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
ease-of-use_Post-intervention
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3 score on a scale
Interval 3.0 to 4.0
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
usefulness_Baseline
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4 score on a scale
Interval 4.0 to 4.0
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
usefulness_Post-intervention
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4 score on a scale
Interval 3.0 to 4.0
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Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
trustworthiness_Baseline
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4 score on a scale
Interval 4.0 to 4.0
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Web-based Simulation Tool (WST)
n=15 Participants
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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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Total-Diabetes-Distress_Baseline
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1.9 score on a scale
Interval 1.5 to 2.0
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Total-Diabetes-Distress_Post-intervention
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1.8 score on a scale
Interval 1.3 to 2.4
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Emotional-Burden_Baseline
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2.2 score on a scale
Interval 1.7 to 3.4
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Emotional-Burden_Post-intervention
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2 score on a scale
Interval 1.7 to 2.4
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Regimen-Distress_Baseline
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1.6 score on a scale
Interval 1.4 to 2.5
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Regimen-Distress_Post-intervention
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1.4 score on a scale
Interval 1.2 to 2.3
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Interpersonal-Distress_Baseline
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2 score on a scale
Interval 1.2 to 2.6
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Interpersonal-Distress_Post-intervention
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2 score on a scale
Interval 1.1 to 2.6
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Physician-Distress_Baseline
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1 score on a scale
Interval 1.0 to 1.2
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Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Physician-Distress_Post-intervention
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1 score on a scale
Interval 1.0 to 1.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Web-based Simulation Tool (WST)
n=15 Participants
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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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)
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-0.8 percentage of time
Standard Deviation 5.8
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OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Web-based Simulation Tool (WST)
n=15 Participants
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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Potential Correlation Between System Use and Changes in Perceived Regimen Distress at Baseline and Week 5 (Post-intervention)
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-0.17 score on a scale
Standard Deviation 0.71
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OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Web-based Simulation Tool (WST)
n=15 Participants
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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Potential Correlation Between System Use and Changes in Perceived Emotional Burden at Baseline and Week 5 (Post-intervention)
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-0.33 score on a scale
Standard Deviation 0.934
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Adverse Events
Web-based Simulation Tool (WST)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Web-based Simulation Tool (WST)
n=15 participants at risk
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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Respiratory, thoracic and mediastinal disorders
COVID positive
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6.7%
1/15 • 5 weeks
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Additional Information
Patricio Colmegna, PhD
University of Virginia Center for Diabetes Technology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place