Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
NCT ID: NCT04443153
Last Updated: 2025-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2020-09-04
2024-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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De-escalation
Subjects randomized to this arm will proceed from DSS to PF to SAM
Personalized Feedback
Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System
CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode
A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
Escalation
Subjects randomized to this arm will proceed from SAM to PF to DSS
Personalized Feedback
Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System
CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode
A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
Interventions
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Personalized Feedback
Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
Decision Support System
CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
Sensor Augmented Mode
A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least one year
* HbA1c 6.0-11.0%, inclusive
* Demonstration of proper mental status and cognition for the study
* If on a non-insulin hyperglycemic therapy, stability on that therapy for the prior 3 months and willingness not to alter the therapy for the study duration.
* For females, not currently known to be pregnant
* If female and sexually active, must agree to use a highly effective form of contraception to prevent pregnancy while a participant in the study. A negative serum or 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. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
* Subjects must have Internet access and a computer system that meets the requirements for uploading the study equipment and ability to participate in video conferencing.
* Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
Exclusion Criteria
* Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
* Current treatment of a primary seizure disorder
* Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
* Hemophilia or any other bleeding disorder
* A known medical condition, which in the opinion of the investigator or designee, would put the participant or study at risk such as the following examples:
* Inpatient psychiatric treatment in the past 6 months
* Presence of a known adrenal disorder
* Abnormal liver function test results (Transaminase \>3 times the upper limit of normal)
* Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2).
* Active gastroparesis requiring medical therapy
* Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L).
* Abuse of alcohol or recreational drugs
* Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
* Uncontrolled arterial hypertension (Resting diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg).
* Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months.
* 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.
* Not familiar with smart phone technology
* Current use of the following drugs and supplements:
* Oral steroids
* Any other medication that the investigator believes is a contraindication to the subject's participation
* Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Virginia
OTHER
Responsible Party
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Marc Breton
Associate Professor
Principal Investigators
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Marc Breton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Center for Diabetes Technology
Locations
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University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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200007
Identifier Type: -
Identifier Source: org_study_id
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