Type 1 DiabetesWSTNCT04439903

Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus

A study testing Web-based Simulation Tool in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Web-based Simulation Tool
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 12 Oct 2020to 22 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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).

Who cannot join

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.*

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia - Center for Diabetes Technology
Charlottesville, Virginia, 22903

Other trials in United States

About this study

Read the 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.

Conditions: Type 1 Diabetes
Being tested: Web-based Simulation Tool
Keywords: Web-based Simulation Tool (WST), Continuous Glucose Monitoring (CGM), Glucose Metabolism Model, Insulin Pump
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Web-based Simulation ToolOther
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.

Study groups in NCT04439903
Study group	Role	What they receive
Web-based Simulation Tool (WST)	Experimental	Not described Receives: Other: Web-based Simulation Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and Week 5 (Post-intervention)

Secondary outcomes (1)

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.
Measured: Baseline and Week 5 (Post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202022 Feb 2021

First posted19 Jun 2020
Study start12 Oct 2020
Primary completion22 Feb 2021
Study completion22 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Single-arm, single center, non-randomized, uncontrolled pilot clinical trial
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04439903
Sponsor's protocol ID: 200157
Acronym: WST
Status last verified: Oct 2024
First submitted: 14 Jun 2020
Last updated: 14 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan to share IPD.

Publications

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.
PubMed 36149995
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.
PubMed 38662425

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04439903
Acronym / sponsor ID: WST / 200157
Conditions: Type 1 Diabetes
Keywords: Web-based Simulation Tool (WST), Continuous Glucose Monitoring (CGM), Glucose Metabolism Model, Insulin Pump
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Juvenile Diabetes Research Foundation, Tandem Diabetes Care, Inc.
Study start: 12 Oct 2020 (actual)
Primary completion: 22 Feb 2021 (actual)
Study completion: 22 Feb 2021 (actual)
First posted: 19 Jun 2020 (actual)
Results: Posted 4 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-arm, single center, non-randomized, uncontrolled pilot clinical trial

Arm	Type	Receives
Web-based Simulation Tool (WST)	Experimental	Other: Web-based Simulation Tool

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Web-based Simulation ToolGlucose, 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.	Other	Web-based Simulation Tool (WST)

Primary outcome

Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)
Time frame: 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.
Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
Time frame: 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.

1 secondary outcome

Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
Time frame: Baseline and Week 5 (Post-intervention)

Results and safety

Results posted to the registry on 4 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Web-based Simulation Tool (WST)	18	15

Primary outcome: Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)

Time frame: Baseline and Week 5 (Post-intervention). Median (Inter-Quartile Range). Unit: percentage of mean item score

Measure	Web-based Simulation Tool (WST) n = 15
Burdens_Baseline	25.0 (14.4 to 38.1)
Burdens_Post-intervention	42.5 (21.3 to 51.3)
Benefits_Baseline	58.9 (52.7 to 68.8)
Benefits_Post-intervention	55.4 (38.4 to 66.1)

Primary outcome: Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)

Time frame: Baseline and Week 5 (Post-intervention). Median (Inter-Quartile Range). Unit: score on a scale

Measure	Web-based Simulation Tool (WST) n = 15
ease-of-use_Baseline	4 (3 to 4)
ease-of-use_Post-intervention	3 (3 to 4)
usefulness_Baseline	4 (4 to 4)
usefulness_Post-intervention	4 (3 to 4)
trustworthiness_Baseline	4 (4 to 4)
trustworthiness_Post-intervention	4 (3 to 4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Web-based Simulation Tool (WST)	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36149995Colmegna 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.
Results publication: PubMed 38662425Colmegna 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.
Individual participant dataSharing planned: No. No plan to share IPD.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricio Colmegna, PhD principal investigator

University of Virginia, Center for Diabetes Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Web-based Simulation Tool in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention) (time frame: Baseline and Week 5 (Post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04439903, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.