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

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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).

Key facts

Study ID

NCT04439903

Run by

University of Virginia

People needed

18

Starts

2020-10-12

Expected to finish

2021-02-22

Last updated by the study team

2024-11-14

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Virginia - Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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