Clinical trial NCT04443153: Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
Official title: Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Behavior
Continuous Glucose Monitor (CGM)
Insulin Pump
Decision Support System (DSS)
Personalized Feedback (PF)
Sensor Augmented Pump therapy (SAP)
Multiple Daily Injections (MDI)
Sensor Augmented Mode (SAM)
Continuous Subcutaneous Insulin Infusion (CSII)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-06-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort will continue for \~7 months. Following recruitment, screening, and a run-in period of SAM, participants will be randomized into one of two groups: escalation vs. de-escalation of devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4 weeks used to assess glucose variability (GV) from CGM data.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Glycemic Outcomes
timeFrame: 7 Months
Secondary outcomes:
measure: percent time in clinical hypoglycemia
timeFrame: 7 months
measure: percent time below recommended threshold
timeFrame: 7 months
measure: percent time in target range
timeFrame: 7 months
measure: percent time above range
timeFrame: 7 months
measure: percent time above 250 mg/dL
timeFrame: 7 months
measure: average glycemia
timeFrame: 7 months
measure: Low Blood Glucose Index
timeFrame: 7 months
measure: High Blood Glucose Index
timeFrame: 7 months
Other outcomes:
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: Marc Breton, PhD
role: PRINCIPAL_INVESTIGATOR
References: