The purpose of this clinical trial is to test the safety and feasibility of using an Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration. Participants will be randomized to either the control group or the experimental group. If in the experimental group, the participant will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days. Researchers will compare the glycemic control of the experimental group to the control group.
The study will involve 20 people with Type 2 Diabetes who are 18 years or older. The study will be performed at the University of Virginia (UVA), with screening procedures taking place either virtually or at the Clinical Research Unit (CRU) at UVA. All participants will undergo a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor (CGM). Participants will be randomized (1:1) to either the Control (CTR) Group or the Experimental (EXP) Group. In the EXP Group, participants will use an Automated Insulin Device (AID) for 10 days in the Basal Insulin Titration (BIT) Phase then return to their original therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP). The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose. During the same 10 days, in the CTR group, participants will use an unblinded CGM and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. Both groups will then go into a 10-days maintenance period using a blinded CGM. Outcomes will be measured in the last 7 days of the BIT and Maintenance Phases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
23
Testing the safety and feasibility of using Automated Insulin Delivery (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
System Testing survey
Receiving feedback from the participants regarding system functionality.
Time frame: 14 days
Percent Time in Range
The percent of time spent within glycemic range of 70 to 180 mg/mL.
Time frame: 14 days
Percent Time Below Range
The percent of time spent below 70 mg/mL.
Time frame: 14 days
Percent Time Above Range
The percent of time spent above 180 mg/mL.
Time frame: 14 days
Percent Time in Tighter Range
The percent of time spent within glycemic range of 70 to 140 mg/mL.
Time frame: 14 days
Percent Time Below Range (Hypoglycemia)
The percent of time spent below 54 mg/mL.
Time frame: 14 days
Percent Time Above Range (Hyperglycemia)
The percent of time spent above 250 mg/mL.
Time frame: 14 days
Mean glucose reading measured by Continuous Glucose Monitor (CGM)
Glucose variability measured by coefficient of variation.
Time frame: 14 days
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