Back to resultsWeb-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus (WST)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based Simulation Tool
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes focused on measuring Web-based Simulation Tool (WST), Continuous Glucose Monitoring (CGM), Glucose Metabolism Model, Insulin Pump
Eligibility Criteria
Inclusion Criteria:
- Age ≥21 and ≤65 years old at time of consent.
- Clinical diagnosis, based on investigator assessment, of T1D for at least one year.
- Using insulin for at least 1 year prior to study enrollment.
- Using an insulin pump for at least 6 months prior to study enrollment.
- Currently using a CGM for at least 6 months.
- Willingness to use a Dexcom G6 CGM during the study; a study Dexcom CGM will be provided if needed.
- Current user of the Tandem t:slim X2 insulin pump.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
- Total daily insulin (TDI) dose at least 10 U/day.
- HbA1c ≤9.0% at screening; if HbA1c <6.0%, then TDI must be ≥ 0.5 U/kg.
- Having access to internet (Wi-Fi or 3G, 4G, 5G, or similar).
- Willingness to interact with a computer program.
- An understanding of and willingness to follow the protocol and sign the informed consent form (ICF).
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.
- Note: The software implementation, in the current development status, is designed to interact with subjects with T1D that only use insulin for diabetes treatment and do not present any comorbidity related to diabetes.
Sites / Locations
- University of Virginia - Center for Diabetes Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Web-based Simulation Tool (WST)
Arm Description
Outcomes
Primary Outcome Measures
Technology Expectation and Technology Acceptance Questionnaires
Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are based on the Bionic Pancreas User Opinion Survey. They were tailored on WST and are made of 27 items scored on a 5-point Likert scale. The items in each questionnaire are almost identical; however, TE questions are in the future tense while TA questions are in the past tense. Participants will be asked to provide their expectation and evaluation regarding ease of use, trustworthy and usefulness of the system. The items in each questionnaire yield to two scores (burdens and benefits), each one is computed as the mean item score converted into a percentage. The TA questionnaire also includes four items that are not part of the standard questionnaire, but will investigate the participants' interaction with WST from a time perspective and assess if they modified their insulin therapy using WST as a source of information.
Secondary Outcome Measures
Diabetes Distress Scale
The Diabetes Distress Scale (DDS) is a 17-item scale that yields a total diabetes distress score plus 4 subscale scores: Emotional burden, regimen distress, interpersonal distress and physician distress. To score, the participants' responses to the appropriate items are summed and divided by the number of items in that scale. A mean item score <2.0 is considered little or no distress, 2.0 - 2.9 is considered moderate distress, and >3.0 is considered high distress.
Full Information
NCT ID
NCT04439903
First Posted
June 14, 2020
Last Updated
March 10, 2021
Sponsor
University of Virginia
Collaborators
Juvenile Diabetes Research Foundation, Tandem Diabetes Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04439903
Brief Title
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Acronym
WST
Official Title
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Juvenile Diabetes Research Foundation, Tandem Diabetes Care, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Web-based Simulation Tool (WST), Continuous Glucose Monitoring (CGM), Glucose Metabolism Model, Insulin Pump
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, single center, non-randomized, uncontrolled pilot clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Web-based Simulation Tool (WST)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Web-based Simulation Tool
Intervention Description
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 Outcome Measure Information:
Title
Technology Expectation and Technology Acceptance Questionnaires
Description
Technology Expectation (TE) and Technology Acceptance (TA) questionnaires are based on the Bionic Pancreas User Opinion Survey. They were tailored on WST and are made of 27 items scored on a 5-point Likert scale. The items in each questionnaire are almost identical; however, TE questions are in the future tense while TA questions are in the past tense. Participants will be asked to provide their expectation and evaluation regarding ease of use, trustworthy and usefulness of the system. The items in each questionnaire yield to two scores (burdens and benefits), each one is computed as the mean item score converted into a percentage. The TA questionnaire also includes four items that are not part of the standard questionnaire, but will investigate the participants' interaction with WST from a time perspective and assess if they modified their insulin therapy using WST as a source of information.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Diabetes Distress Scale
Description
The Diabetes Distress Scale (DDS) is a 17-item scale that yields a total diabetes distress score plus 4 subscale scores: Emotional burden, regimen distress, interpersonal distress and physician distress. To score, the participants' responses to the appropriate items are summed and divided by the number of items in that scale. A mean item score <2.0 is considered little or no distress, 2.0 - 2.9 is considered moderate distress, and >3.0 is considered high distress.
Time Frame
5 weeks
Other Pre-specified Outcome Measures:
Title
Potential Correlation Between System Use and Changes in Treatment Satisfaction and Glucose Control
Description
Weekly glucose metrics from continuous glucose monitoring (CGM) data will be computed as per current consensus guidelines, and used along with the scores of the questionnaires in regression analysis to infer the impact of the duration and frequency of participants' interaction with the application (predictor variables) on variations in metabolic control and treatment satisfaction (response variables).
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥21 and ≤65 years old at time of consent.
Clinical diagnosis, based on investigator assessment, of T1D for at least one year.
Using insulin for at least 1 year prior to study enrollment.
Using an insulin pump for at least 6 months prior to study enrollment.
Currently using a CGM for at least 6 months.
Willingness to use a Dexcom G6 CGM during the study; a study Dexcom CGM will be provided if needed.
Current user of the Tandem t:slim X2 insulin pump.
Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
Total daily insulin (TDI) dose at least 10 U/day.
HbA1c ≤9.0% at screening; if HbA1c <6.0%, then TDI must be ≥ 0.5 U/kg.
Having access to internet (Wi-Fi or 3G, 4G, 5G, or similar).
Willingness to interact with a computer program.
An understanding of and willingness to follow the protocol and sign the informed consent form (ICF).
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.
Note: The software implementation, in the current development status, is designed to interact with subjects with T1D that only use insulin for diabetes treatment and do not present any comorbidity related to diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricio Colmegna, PhD
Organizational Affiliation
University of Virginia, Center for Diabetes Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia - Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD.
Learn more about this trial
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
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