Status:
COMPLETED
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Tandem Diabetes Care, Inc.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
21-65 years
Phase:
NA
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 D...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04439903
Start Date
October 12 2020
End Date
February 22 2021
Last Update
November 14 2024
Active Locations (1)
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1
University of Virginia - Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903