Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice

Abstract

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

Keywords: automated insulin delivery; closed-loop; consensus recommendations; type 1 diabetes.

Graphical abstract

Figure 1.

Automated Insulin Delivery Report: Page 1. Upper Panel, 1, The upper left section contains the clinically important time in ranges (bar) and internationally recognized goals to allow the clinician to quickly ascertain the overall level of glucose management. 2, The essential device use information, including percentage of time AID and CGM were active, along with infusion set and sensor change information, is at the top of the first page to alert the clinician of any data sufficiency or safety concerns. 3, The middle upper panel contains essential glucose metrics, including average glucose, glucose management indicator (GMI), and glucose variability calculated as percentage coefficient of variation. 4, The final component of the upper panel is a table containing detailed insulin metrics divided by how the insulin is delivered, either automatically by the AID system (called automated insulin) or user-initiated insulin delivery. Automated insulin metrics include the average amount of insulin delivered per day and the calculated average units per hour. In addition, the daily average automated correction bolus delivered along with the calculated percentage of total daily dose (TDD) is listed. Detailed insulin metrics describing the average user-initiated amounts of bolus insulin given for food, correction insulin given with the food bolus, and correction only insulin are listed. In addition, the average amount of user overrides insulin delivered per day and average overrides per day are listed. Middle Panel, Below the AGP are the AID system settings, including the insulin to carbohydrate (ICR) (1 unit insulin/g CHO), correction factor (CF) (or ISF, Insulin Sensitivity Factor) (1 unit insulin/mg/dL or 1 unit insulin/mmol/L), algorithm glucose set point and active insulin time (that may or may not be adjusted depending on the AID system). Lower Panel, The mealtime glucose metrics begin 1 hour before the meal to show the user’s average glucose level prior to the meal and ends 4 hours after the start of the meal. The start of the meal is the time when the user-initiated bolus is delivered. The number of days with meal boluses recorded is listed to help identify mealtimes where user-initiated bolus insulin may have been omitted. The average amount of carbs per mealtime is also listed. Of note, automated correction boluses may have also been delivered (in AID systems that have this feature) during the post-meal period and may be reflected in the late post-meal period.

Figure 2.

Automated Insulin Delivery Report: Page 2. 1, The top part of the daily profile displays the CGM tracing and is color coded to match the time in ranges bar (eg, green when in target range of 70 to 180 mg/dL, red when less than 70 mg/dL ang gold when above 180 mg/dL). The user-entered carbohydrate is shown above the CGM tracing in gray circles and total amount of carbohydrates is shown on the bar right. Just below the glucose tracing is the amount of user-initiated bolus insulin in dark purple with the common “insulin sail” to show that active bolus insulin is available. 2, The lower section of the daily profile contains the automated basal insulin tracing in light purple with the left y-axis showing the rate in units/hour and the automated correction boluses delivered with the right y-axis showing units per hour. The total amount of correction boluses delivered in each 1-hour period of the day is shown by the thin blue line with the number of corrections in that hour shown in parenthesis below the total insulin amount. Total insulin amount for each day is shown on the right of each daily profile using icons to designate how the insulin was delivered along with the TDD.