Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes (NCT04443153) | Clinical Trial Compass
CompletedNot Applicable
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
United States88 participantsStarted 2020-09-04
Plain-language summary
This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system performance, which will enable system individualization and lead to automated adaptation of advice delivery to optimize glycemic control and reduce the system's psychological impact.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age 18 years and older
* 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:
* NPH (neutral protamine hagedorn) insulin
* 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 …
What they're measuring
1
Glycemic Outcomes
Timeframe: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention