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. The robust R-AP system used in this protocol has been designed to handle a variety of real-world scenarios that are critical to a high-risk patient population. The investigators will test how well the new algorithm handles missed or inaccurate meal announcements. This type of algorithm may significantly improve glucose control over the standard model predictive control (MPC) closed-loop algorithm without these new algorithm features for patients with type 1 diabetes.
Participants will undergo two visits at Oregon Health and Science University (OHSU) that will evaluate missed meal bolus detection. Participants will arrive at approximately 7am for all visits, be monitored through the afternoon and discharged before dinner. During each of these intervention visits, participants will wear an Omnipod to deliver insulin and a Dexcom G6 Continuous Glucose Monitoring System (CGM) to measure glucose. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. The studies will test the ability of the system to adapt to a missed meal bolus. Participants will eat self selected meals at 10 am and 2pm, both meals with a missed bolus, and these meals will be repeated across both study arms. For one missed meal bolus study, glucose will be controlled using the Robust R-AP closed-loop mode. During the other missed meal bolus study, glucose will be controlled using the MPC closed-loop mode. Participants will complete frequent glucose and ketone checks for safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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 inputs. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure. The metabolic expenditure 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 R-AP is a modified MPC algorithm. A new feature in the algorithm includes a model for missed meal insulin detection. The model includes estimations for carbohydrate consumption based glucose patterns to determine if that person has consumed a meal without announcing it to the system.
Oregon Health and Science University
Portland, Oregon, United States
Area Under the Curve (AUC) of Postprandial Glucose
Incremental AUC of postprandial glucose in the 4 hours following the start of first meal. AUC (mg/dL\*hr) will be calculated using a trapezoidal method, which sums all CGM values taken every 5 minutes in the 4 hour period following the meal above the starting glucose. This yields a maximum of 48 data points for the calculation.
Time frame: 4 hour period following the first meal
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 for the four hour period following the first meal.
Time frame: 4 hour period following the first meal
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 for the 4 hour period following the first meal.
Time frame: 4 hour period following the first meal
Number of Carbohydrate Treatments
Assess the cumulative number of carbohydrate treatments (defined as 15 or 20 grams of carbohydrate) for the four hour period following the first meal.
Time frame: 4 hour period following the first meal
Number of Provider-administered Insulin Injections
Assess the cumulative number of provider-administered insulin injections to treat hyperglycemia in the 4 hour period following the first meal.
Time frame: 4 hour period following the first meal
Mean Sensed Glucose
Assess the mean sensed glucose from the Dexcom G6 reported sensor glucose values for the four hour period following the first meal.
Time frame: 4 hour period following the first meal
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 for the four hour period following the first meal.
Time frame: 4 hour period following the first meal
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 for the four hour period following the first meal.
Time frame: 4 hour period following the first meal
Percent of Time With Sensed Glucose >250 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor for the four hour period following the first meal.
Time frame: 4 hour period following the first meal
Mean Amount of Insulin Delivered Per Day (in Units)
Assess the mean amount of insulin delivered per day by the Omnipod through the AP system study in units for the four hour period following the first meal.
Time frame: 4 hour period following the first meal
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