A Peek Under the Hood: Explaining the MiniMed™ 780G Algorithm with Meal Detection Technology.

The MiniMed™ 780G system (780G) received Conformité Européenne mark in June 2020 and was, recently, approved by the U.S. Food and Drug Administration (April 2023). Clinical trials and real-world analyses have demonstrated MiniMed™ 780G system safety and effectiveness and that glycemic outcomes (i.e., time in range) improve with recommended settings use. In this publication, we will explain the iterative development of the 780G algorithm and how this technology has simplified diabetes management.

Lag Time Remains with Newer Real-Time Continuous Glucose Monitoring Technology During Aerobic Exercise in Adults Living with Type 1 Diabetes.

Background: Real-time continuous glucose monitoring (CGM) devices help detect glycemic excursions associated with exercise, meals, and insulin dosing in patients with type 1 diabetes (T1D). However, the delay between interstitial and blood glucose may result in CGM underestimating the true change in glycemia during activity. The purpose of this study was to examine CGM discrepancies during exercise and the meal postexercise versus self-monitoring of blood glucose (SMBG). Methods: Seventeen adults with T1D using insulin pump therapy and CGM completed 60 min of aerobic exercise on three occasions. A standardized meal was given 30 min postexercise. SMBG was measured during exercise and in recovery using OmniPod® Personal Diabetes Manager (PDM; Insulet, Billerica, MA) with built-in glucose meter (FreeStyle; Abbott Laboratories, Abbott Park, IL), while CGM was measured with Dexcom G4® with 505 algorithm (n = 4) or G5® (n = 13), which were calibrated with subjects' own PDM. Results: SMBG showed a large drop in glycemia during exercise, while CGM showed a lag of 12 ± 11 (mean ± standard deviation) minutes and bias of -7 ± 19 mg/dL/min during activity. Mean absolute relative difference (MARD) for CGM versus SMBG was 13 (6-22)% [median (interquartile range)] during exercise and 8 (5-14)% during mealtime. Clarke error grids showed CGM values were in zones A and B 94%-99% of the time for SMBG. Conclusion: In summary, the drop in CGM lags behind the drop in blood glucose during prolonged aerobic exercise by 12 ± 11 min, and MARD increases to 13 (6-22)% during exercise as well. Therefore, if hypoglycemia is suspected during exercise, individuals should confirm glucose levels with a capillary glucose measurement.

Improving Glucose Prediction Accuracy in Physically Active Adolescents With Type 1 Diabetes.

BACKGROUND: Physical activity presents a significant challenge for glycemic control in individuals with type 1 diabetes. As accurate glycemic predictions are key to successful automated decision-making systems (eg, artificial pancreas, AP), the inclusion of additional physiological variables in the estimation of the metabolic state may improve the glucose prediction accuracy during exercise. METHODS: Predictor-based subspace identification is applied to a dynamic glucose prediction model including heart rate measurements along with variables representing the carbohydrate consumption and insulin boluses. To demonstrate the improvement in prediction ability due to the additional heart rate variable, the performance of the proposed modeling technique is evaluated with (SID-HR) and without heart rate (SID-2) as an additional input using experimental data involving adolescents at ski camp. Furthermore, the performance of the proposed approach is compared to that of the metabolic state observer (MSO) model currently used in the University of Virginia AP algorithm. RESULTS: The addition of heart rate in the subspace-based model (SID-HR) yields a statistically significant improvement in the root-mean-square error compared to the SID-2 model (P < .001) and the standard MSO (P < .001). Furthermore, the SID-HR model performed favorably in comparison to the SID-2 and MSO models after accounting for its increased complexity. CONCLUSIONS: Directly considering the effects of physical activity levels on glycemic dynamics through the inclusion of heart rate as an additional input variable in the glucose dynamics model improves the glucose prediction accuracy. The proposed methodology could improve exercise-informed model-based predictive control algorithms in artificial pancreas systems.

Multi-level Supervision and Modification of Artificial Pancreas Control System.

Artificial pancreas (AP) systems provide automated regulation of blood glucose concentration (BGC) for people with type 1 diabetes (T1D). An AP includes three components: a continuous glucose monitoring (CGM) sensor, a controller calculating insulin infusion rate based on the CGM signal, and a pump delivering the insulin amount calculated by the controller to the patient. The performance of the AP system depends on successful operation of these three components. Many APs use model predictive controllers that rely on models to predict BGC and to calculate the optimal insulin infusion rate. The performance of model-based controllers depends on the accuracy of the models that is affected by large dynamic changes in glucose-insulin metabolism or equipment performance that may move the operating conditions away from those used in developing the models and designing the control system. Sensor errors and missing signals will cause calculation of erroneous insulin infusion rates. And the performance of the controller may vary at each sampling step and each period (meal, exercise, and sleep), and from day to day. Here we describe a multi-level supervision and controller modification (ML-SCM) module is developed to supervise the performance of the AP system and retune the controller. It supervises AP performance in 3 time windows: sample level, period level, and day level. At sample level, an online controller performance assessment sub-module will generate controller performance indexes to evaluate various components of the AP system and conservatively modify the controller. A sensor error detection and signal reconciliation module will detect sensor error and reconcile the CGM sensor signal at each sample. At period level, the controller performance is evaluated with information collected during a certain time period and the controller is tuned more aggressively. At the day level, the daily CGM ranges are further analyzed to determine the adjustable range of controller parameters used for sample level and period level. Thirty subjects in the UVa/Padova metabolic simulator were used to evaluate the performance of the ML-SCM module and one clinical experiment is used to illustrate its performance in a clinical environment. The results indicate that the AP system with an ML-SCM module has a safer range of glucose concentration distribution and more appropriate insulin infusion rate suggestions than an AP system without the ML-SCM module.

Multivariable Artificial Pancreas for Various Exercise Types and Intensities.

BACKGROUND: Exercise challenges people with type 1 diabetes in controlling their glucose concentration (GC). A multivariable adaptive artificial pancreas (MAAP) may lessen the burden. METHODS: The MAAP operates without any user input and computes insulin based on continuous glucose monitor and physical activity signals. To analyze performance, 18 60-h closed-loop experiments with 96 exercise sessions with three different protocols were completed. Each day, the subjects completed one resistance and one treadmill exercise (moderate continuous training [MCT] or high-intensity interval training [HIIT]). The primary outcome is time spent in each glycemic range during the exercise + recovery period. Secondary measures include average GC and average change in GC during each exercise modality. RESULTS: The GC during exercise + recovery periods were within the euglycemic range (70-180 mg/dL) for 69.9% of the time and within a safe glycemic range for exercise (70-250 mg/dL) for 93.0% of the time. The exercise sessions are defined to begin 30 min before the start of exercise and end 2 h after start of exercise. The GC were within the severe hypoglycemia (<55 mg/dL), moderate hypoglycemia (55-70 mg/dL), moderate hyperglycemia (180-250 mg/dL), and severe hyperglycemia (>250 mg/dL) for 0.9%, 1.3%, 23.1%, and 4.8% of the time, respectively. The average GC decline during exercise differed with exercise type (P = 0.0097) with a significant difference between the MCT and resistance (P = 0.0075). To prevent large GC decreases leading to hypoglycemia, MAAP recommended carbohydrates in 59% of MCT, 50% of HIIT, and 39% of resistance sessions. CONCLUSIONS: A consistent GC decline occurred in exercise and recovery periods, which differed with exercise type. The average GC at the start of exercise was above target (185.5 ± 56.6 mg/dL for MCT, 166.9 ± 61.9 mg/dL for resistance training, and 171.7 ± 41.4 mg/dL HIIT), making a small decrease desirable. Hypoglycemic events occurred in 14.6% of exercise sessions and represented only 2.22% of the exercise and recovery period.

Incorporating Unannounced Meals and Exercise in Adaptive Learning of Personalized Models for Multivariable Artificial Pancreas Systems.

BACKGROUND: Despite the recent advancements in the modeling of glycemic dynamics for type 1 diabetes mellitus, automatically considering unannounced meals and exercise without manual user inputs remains challenging. METHOD: An adaptive model identification technique that incorporates exercise information and estimates of the effects of unannounced meals obtained automatically without user input is proposed in this work. The effects of the unknown consumed carbohydrates are estimated using an individualized unscented Kalman filtering algorithm employing an augmented glucose-insulin dynamic model, and exercise information is acquired from noninvasive physiological measurements. The additional information on meals and exercise is incorporated with personalized estimates of plasma insulin concentration and glucose measurement data in an adaptive model identification algorithm. RESULTS: The efficacy of the proposed personalized and adaptive modeling algorithm is demonstrated using clinical data involving closed-loop experiments of the artificial pancreas system, and the results demonstrate accurate glycemic modeling with the average root-mean-square error (mean absolute error) of 25.50 mg/dL (18.18 mg/dL) for six-step (30 minutes ahead) predictions. CONCLUSIONS: The approach presented is able to identify reliable time-varying individualized glucose-insulin models.

Adaptive and Personalized Plasma Insulin Concentration Estimation for Artificial Pancreas Systems.

BACKGROUND: The artificial pancreas (AP) system, a technology that automatically administers exogenous insulin in people with type 1 diabetes mellitus (T1DM) to regulate their blood glucose concentrations, necessitates the estimation of the amount of active insulin already present in the body to avoid overdosing. METHOD: An adaptive and personalized plasma insulin concentration (PIC) estimator is designed in this work to accurately quantify the insulin present in the bloodstream. The proposed PIC estimation approach incorporates Hovorka's glucose-insulin model with the unscented Kalman filtering algorithm. Methods for the personalized initialization of the time-varying model parameters to individual patients for improved estimator convergence are developed. Data from 20 three-days-long closed-loop clinical experiments conducted involving subjects with T1DM are used to evaluate the proposed PIC estimation approach. RESULTS: The proposed methods are applied to the clinical data containing significant disturbances, such as unannounced meals and exercise, and the results demonstrate the accurate real-time estimation of the PIC with the root mean square error of 7.15 and 9.25 mU/L for the optimization-based fitted parameters and partial least squares regression-based testing parameters, respectively. CONCLUSIONS: The accurate real-time estimation of PIC will benefit the AP systems by preventing overdelivery of insulin when significant insulin is present in the bloodstream.

Automatic Detection and Estimation of Unannounced Meals for Multivariable Artificial Pancreas System.

BACKGROUND: Automatically attenuating the postprandial rise in the blood glucose concentration without manual meal announcement is a significant challenge for artificial pancreas (AP) systems. In this study, a meal module is proposed to detect the consumption of a meal and to estimate the amount of carbohydrate (CHO) intake. METHODS: The meals are detected based on qualitative variables describing variation of continuous glucose monitoring (CGM) readings. The CHO content of the meals/snacks is estimated by a fuzzy system using CGM and subcutaneous insulin delivery data. The meal bolus amount is computed according to the patient's insulin to CHO ratio. Integration of the meal module into a multivariable AP system allows revision of estimated CHO based on knowledge about physical activity, sleep, and the risk of hypoglycemia before the final decision for a meal bolus is made. RESULTS: The algorithm is evaluated by using 117 meals/snacks in retrospective data from 11 subjects with type 1 diabetes. Sensitivity, defined as the percentage of correctly detected meals and snacks, is 93.5% for meals and 68.0% for snacks. The percentage of false positives, defined as the proportion of false detections relative to the total number of detected meals and snacks, is 20.8%. CONCLUSIONS: Integration of a meal detection module in an AP system is a further step toward an automated AP without manual entries. Detection of a consumed meal/snack and infusion of insulin boluses using an estimate of CHO enables the AP system to automatically prevent postprandial hyperglycemia.

Model-Fusion-Based Online Glucose Concentration Predictions in People with Type 1 Diabetes.

Accurate predictions of glucose concentrations are necessary to develop an artificial pancreas (AP) system for people with type 1 diabetes (T1D). In this work, a novel glucose forecasting paradigm based on a model fusion strategy is developed to accurately characterize the variability and transient dynamics of glycemic measurements. To this end, four different adaptive filters and a fusion mechanism are proposed for use in the online prediction of future glucose trajectories. The filter fusion mechanism is developed based on various prediction performance indexes to guide the overall output of the forecasting paradigm. The efficiency of the proposed model fusion based forecasting method is evaluated using simulated and clinical datasets, and the results demonstrate the capability and prediction accuracy of the data-based fusion filters, especially in the case of limited data availability. The model fusion framework may be used in the development of an AP system for glucose regulation in patients with T1D.

The Effects of Basal Insulin Suspension at the Start of Exercise on Blood Glucose Levels During Continuous Versus Circuit-Based Exercise in Individuals with Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion.

BACKGROUND: Exercise causes glycemic disturbances in individuals with type 1 diabetes (T1D). Continuous moderate-intensity aerobic exercise (CON) generally lowers blood glucose (BG) levels and often leads to hypoglycemia. In comparison, circuit-based exercise (CIRC) may attenuate the drop in BG. The goal of this study is to contrast the effects of basal insulin suspension at the onset of two different forms of exercise (CON vs. CIRC). METHODS: Twelve individuals (six men and six women) with T1D on insulin pump therapy were recruited for the study. All participants completed a maximal aerobic fitness test and two 40-min exercise sessions, consisting of either continuous treadmill walking or a circuit workout. Basal insulin infusion was stopped at the onset of exercise and resumed in recovery. After providing an initial reference value, volunteers were blinded to their [BG] and were asked to estimate their levels during exercise. RESULTS: Oxygen consumption (47.5 ± 7.5 vs. 54.5 ± 13.5 mL·kg-1·min-1, P = 0.03) and heart rate (122 ± 20 vs. 144 ± 20 bpm, P = 0.003) were lower in CON vs. CIRC. Despite the lower workload, BG levels dropped more with CON vs. CIRC (delta BG = -3.8 ± 1.5 vs. -0.5 ± 3.0 mmol/L for CON vs. CIRC, respectively, P = 0.001). Participants were able to estimate their BG more accurately during CON (r = 0.83) vs. CIRC (r = 0.33) based on a regression analysis. CONCLUSION: Despite a lower intensity of exercise, with full basal insulin suspension at the start of exercise, CON results in a larger drop in BG vs. CIRC. These findings have implications for single hormone-based artificial pancreas development for exercise. While this study does not negate the importance of frequent capillary BG monitoring during exercise, it does suggest that if persons are knowledgeable about their pre-exercise BG levels, they can accurately perceive the changes in BG during CON, but not during CIRC.

Meal Detection and Carbohydrate Estimation Using Continuous Glucose Sensor Data.

A meal detection and meal-size estimation algorithm is developed for use in artificial pancreas (AP) control systems for people with type 1 diabetes. The algorithm detects the consumption of a meal and estimates its carbohydrate (CHO) amount to determine the appropriate dose of insulin bolus for a meal. It can be used in AP systems without manual meal announcements, or as a safety feature for people who may forget entering meal information manually. Using qualitative representation of the filtered continuous glucose monitor signal, a time period labeled as meal flag is identified. At every sampling time during this time period, a fuzzy system estimates the amount of CHO. Meal size estimator uses both glucose sensor and insulin data. Meal insulin bolus is based on estimated CHO. The algorithm does not change the basal insulin rate. Thirty in silico subjects of the UVa/Padova simulator are used to illustrate the performance of the algorithm. For the evaluation dataset, the sensitivity and false positives detection rates are 91.3% and 9.3%, respectively, the absolute error in CHO estimation is 23.1%, the mean blood glucose level is 142 mg/dl, and glucose concentration stays in target range (70-180 mg/dl) for 76.8% of simulation duration on average.

Use of Wearable Sensors and Biometric Variables in an Artificial Pancreas System.

An artificial pancreas (AP) computes the optimal insulin dose to be infused through an insulin pump in people with Type 1 Diabetes (T1D) based on information received from a continuous glucose monitoring (CGM) sensor. It has been recognized that exercise is a major challenge in the development of an AP system. The use of biometric physiological variables in an AP system may be beneficial for prevention of exercise-induced challenges and better glucose regulation. The goal of the present study is to find a correlation between biometric variables such as heart rate (HR), heat flux (HF), skin temperature (ST), near-body temperature (NBT), galvanic skin response (GSR), and energy expenditure (EE), 2D acceleration-mean of absolute difference (MAD) and changes in glucose concentrations during exercise via partial least squares (PLS) regression and variable importance in projection (VIP) in order to determine which variables would be most useful to include in a future artificial pancreas. PLS and VIP analyses were performed on data sets that included seven different types of exercises. Data were collected from 26 clinical experiments. Clinical results indicate ST to be the most consistently important (important for six out of seven tested exercises) variable over all different exercises tested. EE and HR are also found to be important variables over several types of exercise. We also found that the importance of GSR and NBT observed in our experiments might be related to stress and the effect of changes in environmental temperature on glucose concentrations. The use of the biometric measurements in an AP system may provide better control of glucose concentration.

Real-Time Model-Based Fault Detection of Continuous Glucose Sensor Measurements.

OBJECTIVE: Faults in subcutaneous glucose concentration readings with a continuous glucose monitoring (CGM) may affect the computation of insulin infusion rates that can lead to hypoglycemia or hyperglycemia in artificial pancreas control systems for patients with type 1 diabetes (T1D). METHODS: Multivariable statistical monitoring methods are proposed for detection of faults in glucose concentration values reported by a subcutaneous glucose sensor. A nonlinear first principle glucose/insulin/meal dynamic model is developed. An unscented Kalman filter is used for state and parameter estimation of the nonlinear model. Principal component analysis models are developed and used for detection of dynamic changes. K-nearest neighbor classification algorithm is used for diagnosis of faults. Data from 51 subjects are used to assess the performance of the algorithm. RESULTS: The results indicate that the proposed algorithm works successfully with 84.2% sensitivity. Overall, 155 (out of 184) of the CGM failures are detected with a 2.8-min average detection time. CONCLUSION: A novel algorithm that integrates data-driven and model-based methods is developed. The proposed method is able to detect CGM failures with a high rate of success. SIGNIFICANCE: The proposed fault detection algorithm can decrease the effects of faults on insulin infusion rates and reduce the potential for hypo- or hyperglycemia for patients with T1D.

Hybrid online sensor error detection and functional redundancy for systems with time-varying parameters.

Supervision and control systems rely on signals from sensors to receive information to monitor the operation of a system and adjust manipulated variables to achieve the control objective. However, sensor performance is often limited by their working conditions and sensors may also be subjected to interference by other devices. Many different types of sensor errors such as outliers, missing values, drifts and corruption with noise may occur during process operation. A hybrid online sensor error detection and functional redundancy system is developed to detect errors in online signals, and replace erroneous or missing values detected with model-based estimates. The proposed hybrid system relies on two techniques, an outlier-robust Kalman filter (ORKF) and a locally-weighted partial least squares (LW-PLS) regression model, which leverage the advantages of automatic measurement error elimination with ORKF and data-driven prediction with LW-PLS. The system includes a nominal angle analysis (NAA) method to distinguish between signal faults and large changes in sensor values caused by real dynamic changes in process operation. The performance of the system is illustrated with clinical data continuous glucose monitoring (CGM) sensors from people with type 1 diabetes. More than 50,000 CGM sensor errors were added to original CGM signals from 25 clinical experiments, then the performance of error detection and functional redundancy algorithms were analyzed. The results indicate that the proposed system can successfully detect most of the erroneous signals and substitute them with reasonable estimated values computed by functional redundancy system.

Hypoglycemia Detection and Carbohydrate Suggestion in an Artificial Pancreas.

Fear of hypoglycemia is a major concern for many patients with type 1 diabetes and affects patient decisions for use of an artificial pancreas system. We propose an alternative way for prevention of hypoglycemia by issuing predictive hypoglycemia alarms and encouraging patients to consume carbohydrates in a timely manner. The algorithm has been tested on 6 subjects (3 males and 3 females, age 24.2 ± 4.5 years, weight 79.2 ± 16.2 kg, height 172.7 ± 9.4 cm, HbA1C 7.3 ± 0.48%, duration of diabetes 209.2 ± 87.9 months) over 3-day closed-loop clinical experiments as part of a multivariable artificial pancreas control system. Over 6 three-day clinical experiments, there were only 5 real hypoglycemia episodes, of which only 1 hypoglycemia episode occurred due to being missed by the proposed algorithm. The average hypoglycemia alarms per day and per subject was 3. Average glucose value when the first alarms were triggered was recorded to be 117 ± 30.6 mg/dl. Average carbohydrate consumption per alarm was 14 ± 7.8 grams. Our results have shown that most low glucose concentrations can be predicted in advance and the glucose levels can be raised back to the desired levels by consuming an appropriate amount of carbohydrate. The proposed algorithm is able to prevent most hypoglycemic events by suggesting appropriate levels of carbohydrate consumption before the actual occurrence of hypoglycemia.

Meal Detection in Patients With Type 1 Diabetes: A New Module for the Multivariable Adaptive Artificial Pancreas Control System.

A novel meal-detection algorithm is developed based on continuous glucose measurements. Bergman's minimal model is modified and used in an unscented Kalman filter for state estimations. The estimated rate of appearance of glucose is used for meal detection. Data from nine subjects are used to assess the performance of the algorithm. The results indicate that the proposed algorithm works successfully with high accuracy. The average change in glucose levels between the meals and the detection points is 16(±9.42) [mg/dl] for 61 successfully detected meals and snacks. The algorithm is developed as a new module of an integrated multivariable adaptive artificial pancreas control system. Meal detection with the proposed method is used to administer insulin boluses and prevent most of postprandial hyperglycemia without any manual meal announcements. A novel meal bolus calculation method is proposed and tested with the UVA/Padova simulator. The results indicate significant reduction in hyperglycemia.

Classification of Physical Activity: Information to Artificial Pancreas Control Systems in Real Time.

Physical activity has a wide range of effects on glucose concentrations in type 1 diabetes (T1D) depending on the type (ie, aerobic, anaerobic, mixed) and duration of activity performed. This variability in glucose responses to physical activity makes the development of artificial pancreas (AP) systems challenging. Automatic detection of exercise type and intensity, and its classification as aerobic or anaerobic would provide valuable information to AP control algorithms. This can be achieved by using a multivariable AP approach where biometric variables are measured and reported to the AP at high frequency. We developed a classification system that identifies, in real time, the exercise intensity and its reliance on aerobic or anaerobic metabolism and tested this approach using clinical data collected from 5 persons with T1D and 3 individuals without T1D in a controlled laboratory setting using a variety of common types of physical activity. The classifier had an average sensitivity of 98.7% for physiological data collected over a range of exercise modalities and intensities in these subjects. The classifier will be added as a new module to the integrated multivariable adaptive AP system to enable the detection of aerobic and anaerobic exercise for enhancing the accuracy of insulin infusion strategies during and after exercise.

An integrated multivariable artificial pancreas control system.

The objective was to develop a closed-loop (CL) artificial pancreas (AP) control system that uses continuous measurements of glucose concentration and physiological variables, integrated with a hypoglycemia early alarm module to regulate glucose concentration and prevent hypoglycemia. Eleven open-loop (OL) and 9 CL experiments were performed. A multivariable adaptive artificial pancreas (MAAP) system was used for the first 6 CL experiments. An integrated multivariable adaptive artificial pancreas (IMAAP) system consisting of MAAP augmented with a hypoglycemia early alarm system was used during the last 3 CL experiments. Glucose values and physical activity information were measured and transferred to the controller every 10 minutes and insulin suggestions were entered to the pump manually. All experiments were designed to be close to real-life conditions. Severe hypoglycemic episodes were seen several times during the OL experiments. With the MAAP system, the occurrence of severe hypoglycemia was decreased significantly (P < .01). No hypoglycemia was seen with the IMAAP system. There was also a significant difference (P < .01) between OL and CL experiments with regard to percentage of glucose concentration (54% vs 58%) that remained within target range (70-180 mg/dl). Integration of an adaptive control and hypoglycemia early alarm system was able to keep glucose concentration values in target range in patients with type 1 diabetes. Postprandial hypoglycemia and exercise-induced hypoglycemia did not occur when this system was used. Physical activity information improved estimation of the blood glucose concentration and effectiveness of the control system.

Adaptive control of artificial pancreas systems - a review.

Artificial pancreas (AP) systems offer an important improvement in regulating blood glucose concentration for patients with type 1 diabetes, compared to current approaches. AP consists of sensors, control algorithms and an insulin pump. Different AP control algorithms such as proportional-integral-derivative, model-predictive control, adaptive control, and fuzzy logic control have been investigated in simulation and clinical studies in the past three decades. The variability over time and complexity of the dynamics of blood glucose concentration, unsteady disturbances such as meals, time-varying delays on measurements and insulin infusion, and noisy data from sensors create a challenging system to AP. Adaptive control is a powerful control technique that can deal with such challenges. In this paper, a review of adaptive control techniques for blood glucose regulation with an AP system is presented. The investigations and advances in technology produced impressive results, but there is still a need for a reliable AP system that is both commercially viable and appealing to patients with type 1 diabetes.