Clinical trial NCT04439903: Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Official title: Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Web-based Simulation Tool (WST)
Continuous Glucose Monitoring (CGM)
Glucose Metabolism Model
Insulin Pump
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Tandem Diabetes Care, Inc.
First posted: 2020-06-19
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, single center, non-randomized, uncontrolled pilot clinical trial
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Technology Expectation and Technology Acceptance Questionnaires: Perceived Burdens and Benefits at Baseline and Week 5 (Post-intervention)
timeFrame: Baseline and Week 5 (Post-intervention)
measure: Technology Expectation and Technology Acceptance Questionnaires: Perceived Ease of Use, Usefulness and Trustworthiness of the System at Baseline and Week 5 (Post-intervention)
timeFrame: Baseline and Week 5 (Post-intervention)
Secondary outcomes:
measure: Diabetes Distress Scale at Baseline and Week 5 (Post-intervention)
timeFrame: Baseline and Week 5 (Post-intervention)
Other outcomes:
measure: 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)
timeFrame: First Week (Observation) and Following 4 Weeks (Intervention)
measure: Potential Correlation Between System Use and Changes in Perceived Regimen Distress at Baseline and Week 5 (Post-intervention)
timeFrame: Baseline and Week 5 (Post-intervention)
measure: Potential Correlation Between System Use and Changes in Perceived Emotional Burden at Baseline and Week 5 (Post-intervention)
timeFrame: Baseline and Week 5 (Post-intervention)
Locations:
city: Charlottesville
country: United States
facility: University of Virginia - Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia, Center for Diabetes Technology
name: Patricio Colmegna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.