The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.
This study will evaluate up to 15 subjects in each age group for a period of 8-10 weeks performing neurocognitive tests before and after each intervention. The first study phase will be up to 2 weeks of a training period to allow participants to get acquainted with the use of the CGM if they are not familiar with the use of the device. This training period will be followed by a 4-week sensor-augmented pump (SAP) period using a study CGM and the subject's personal insulin pump. The subjects will return to clinic at the completion of the SAP period and will be trained on the Tandem t:slim X2 with Control-IQ and G6 CGM. At the completion of the system training session, subjects will begin 4-weeks of Closed-Loop Control (CLC). Questionnaires will be completed by the study subject at screening, after completion of SAP and after completion of CLC. Ecological Momentary Assessments (EMAs) and actigraphy data will be collected in the last 14 days of the SAP and CLC periods. A parent/guardian of the enrolled children will also be asked to participate in all trainings, complete parental Patient-Report Outcomes (PRO) Questionnaires, and collect sleep patterns while wearing the actigraph watch.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
University of Virginia
Charlottesville, Virginia, United States
Percentage of Time of Blood Glucose in Range 70-180 mg/dL
Percentage of time of blood glucose in range 70-180 mg/dL as measured by the continuous glucose monitor.
Time frame: One month during each study period (sensor augmented pump and closed loop control)
Ecological Momentary Assessments
Positive Moods were assessed using Ecological Momentary Assessments. Participants were asked a question on positive moods and answered on a Likert scale from 0 to 4 with a higher score indicating more positive mood. Scores were averaged from all evaluable completed assessment that were completed in the final 14 days of each study period.
Time frame: Assessments will be administered during the final 14 days of each study period (sensor-augmented pump and closed-loop control).
Sleep Patterns
Pittsburgh Sleep Quality Index (PSQI): a 10-item questionnaire assessment of sleep quality disturbances over the last month. Individual Items are rated on a 4 point Likert scale ranging from 0 to 3, which are then used to calculate a Global Score which can range from 0 to 21 with higher scores reflecting worse sleep quality. Parents completed the questionnaire for the young children cohort.
Time frame: Assessments will be made at baseline and at the end of each study SAP (4 weeks) and CLC (4 weeks).
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