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

NCT04439903 | Completed Results

• 1 other identifier: 200157
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes

Keywords

Web-based Simulation Tool (WST); Continuous Glucose Monitoring (CGM); Glucose Metabolism Model; Insulin Pump

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (1)

• Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)

  Baseline and Week 5 (Post-intervention)

Other Outcomes (3)

• 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)

  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)

  Baseline and Week 5 (Post-intervention)

• Potential Correlation Between System Use and Changes in Perceived Emotional Burden at Baseline and Week 5 (Post-intervention)

  Baseline and Week 5 (Post-intervention)

Study Arms (1)

Web-based Simulation Tool (WST)

EXPERIMENTAL

Other: Web-based Simulation Tool

Interventions

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.

Web-based Simulation Tool (WST)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• Juvenile Diabetes Research Foundation: collaborator
• Tandem Diabetes Care, Inc.: collaborator

Study Sites (1)

University of Virginia - Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (2)

• 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.

  PMID: 36149995 BACKGROUND

• 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.

  PMID: 38662425 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

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).

Results Point of Contact

• Title: Patricio Colmegna, PhD
• Organization: University of Virginia Center for Diabetes Technology

pc2jx@virginia.edu

434-924-5592

Study Officials

• Patricio Colmegna, PhD

  University of Virginia, Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Single-arm, single center, non-randomized, uncontrolled pilot clinical trial

Study Record Dates

• First Submitted: June 14, 2020
• First Posted: June 19, 2020
• Study Start: October 12, 2020
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: November 14, 2024
• Results First Posted: December 4, 2023

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)