An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. If a meal is detected that was not reported by the user, the system shall calculate the amount of meal insulin that will be dosed and deliver that insulin. The investigators will test how well the new algorithm manages glucose compared to the participant's usual care including the tslim X2 pump with Control IQ enabled. This type of algorithm may improve glucose control for high risk patient populations.
Participants will undergo one 7-day Intervention Period and one 7-day Control Period in randomized order. During the 7-day intervention, participants will wear an Omnipod to deliver Fiasp insulin and a Dexcom G6 CGM. The CGM system will provide sensed glucose data every 5 minutes. Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 to the smartphone master controller every 5 minutes. The smartphone will communicate via BTLE to an Omnipod for insulin delivery. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. Participants will eat one meal in clinic and complete system training on Day 1 and then spend the rest of the 7 days at home. During the 7-day control, the participant will continue their usual diabetes care regimen using the tslim X2 pump with Dexcom G6 with Control IQ enabled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled.
The t:slim pump is a hybrid closed-loop system available to consumers for automated insulin delivery. Control IQ technology automatically adjusts insulin levels based on continuous glucose monitoring (CGM) readings from Dexcom G6.
Oregon Health and Science University
Portland, Oregon, United States
University of Washington
Seattle, Washington, United States
Percent of Time With Sensed Glucose Between 70-180 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor across both arms.
Time frame: 7 days in each treatment arm
Percent of Time With Sensed Glucose < 54 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor across both arms.
Time frame: 7 days in each treatment arm
Percent of Time With Sensed Glucose < 70 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across both arms.
Time frame: 7 days in each treatment arm
Percent of Time With Sensed Glucose > 180 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor across both arms.
Time frame: 7 days in each treatment arm
Mean Sensed Glucose
Mean sensed glucose from the Dexcom G6 reported sensor glucose values. 7 days in each treatment arm: Sensed Glucose values were averaged across the 7 days for MPC Intervention and and across the 7 days for Control
Time frame: 7 days in each treatment arm
Coefficient of Variation of Glucose (Unitless)
Continuous glucose monitoring (CGM) values were recorded every five minutes and summarized for each treatment arm. Coefficient of variation was calculated as 100 \* (standard deviation) / (mean) of sensed glucose. Lower values are desirable for this outcome. This is a ratio. Thus, there are no units for this outcome.
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Time frame: 7 days in each treatment arm
Mean Amount of Insulin Delivered Per Day (in Units/kg)
Access the mean amount of insulin delivered per day by the Omnipod through the AP system study in units/kg across both arms.
Time frame: 7 days in each treatment arm