N/A
N=18
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04439903 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention) — 25.0; 42.5; 58.9; 55.4 percentage of mean item score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Web-based Simulation Tool (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention) |
25.0; 42.5; 58.9; 55.4 | — |
| PRIMARY Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention) |
4; 3; 4; 4; 4; 4 | — |
| SECONDARY Diabetes Distress Scale at Baseline and Week 5 (Post-intervention) |
1.9; 1.8; 2.2; 2; 1.6; 1.4 | — |
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).
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 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.
Data sourced from ClinicalTrials.gov (NCT04439903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.