New Omnipod 5 Data Details Use in Real-World Settings

Courtesy: Insulet

With the January 2022 approval introducing people with type 1 diabetes who take basal and mealtime insulin to a tubeless automated insulin delivery (AID) system, a new era of patient choice was brought forth to the community.

Now, early in 2023, new data from the Omnipod 5 AID system presented at the 16th annual conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023) is offering further insight into the utility of the system in different patient populations and settings, including use in inpatient settings for remote monitoring.

“Using automated insulin delivery in the hospital produced encouraging results across a heterogenous group of patients, including both type 1 and type 2 diabetes, steroid use, and a range of admission diagnoses,” said Michael Hughes, MD, of Stanford University.¹ “This is an important step forward for inpatient diabetes management. We hope these data can help us move further toward development of inpatient-specific features, algorithms, and systems.”

Omnipod at ATTD 2023

AIDING Feasibility Study²

A single-arm, multicenter pilot trial, the Automated Insulin Delivery for Inpatients with Dysglycemia (AIDING) Feasibility study was launched with the intent of assessing the feasibility, safety, and efficacy of using the Omnipod 5 AID system with remote real-time CGM with the Dexcom G6 for inpatients with multiple daily insulin injections. In the study, which enrolled patients type 1 (T1D) or type 2 (T2D) diabetes on non-ICU medical-surgical units.²

The primary outcomes of interest for the study included the proportion of time in automated mode and percentage of time spent in range of 70-180 mg/dL. System use in the study lasted for up to 10 days or until discharge. Per trial protocol, insulin boluses were delivered by bedside nurses.²

Hughes presented data related to system use among a cohort of 16 patients with 90 days of total data. Of the 16 patients, 2 had T1D and 14 had T2D. The mean system use time was 5.6±2.8 days. Analysis of patient data demonstrated the median percent of time in automated mode was 99% (Interquartile Range [IQR], 95-99), mean time in range of 68% (SD, 16),time below 70 mg/dL was 0.15% (SD, 0.3), and mean time below 54 mg/dL was 0.06% (SD, 0.2).²

Further analysis demonstrated the mean glucose value during system use was 168 (SD, 21) mg/dL. Safety analyses demonstrated there was no incidence of diabetic ketoacidosis or severe hypoglycemia among study participants.²

Who is Using Omnipod³

Research presented by Emily Soriano, MA, of the Scripps Whittier Diabetes Institute, described characteristics of insulin-using adults with T2D who make the decision to initiate pump therapy. Using anonymous self-reported survey data from 435 individuals, study investigators provided an overview of the sociodemographic, diabetes regimen and history, overall well-being, and levels of diabetes-related distress before beginning pump use with the Omnipod DASH Insulin Management System.³

The study cohort had a mean age of 53.5 (SD, 12.2) years, 60.7% were female, and 71.0% self-reported non-Hispanic White as race/ethnicity. Further analysis of survey respondents indicated the cohort had a mean BMI of 35.9 (SD, 8.8) kg/m², mean self-reported HbA1c of 8.8% (SD, 2.0), and 40.2% reported an HbA1c greater than 9.0%. Real-time continuous glucose monitoring was reported among 70.7% of the study cohort.³

Additionally, investigators pointed out 52.9% of respondents reported missing at least 1 basal injection and 67.9% reported missing at least 1 mealtime injection int eh past week. Investigators also pointed out overall well-being was poor, with mean WHO-5 score of 40.5 (SD, 21.9), and a mean T2-DDAS Core score of 3.4 (SD, 1.0).³

Glycemic Control in Children and Young Adults in Real-World Settings⁴

A team of investigators representing institutions in multiple European countries launched a study with the intent of examining metabolic control and health resource use in a cohort of children and young adults with T1D using tubeless insulin pumps in combination with glucose sensors compared to their counterparts using multiple daily injections in combination with glucose sensors. Leveraging real-world data from the multicenter Diabetes-Patienten-Verlaufsdokumentation (DPV) registry, investigators obtained data related to a cohort of 2480 matched pairs of individual aged younger than25 years of age with a least 3 months of follow-up.⁴

For the purpose of analysis, propensity score matching was based on sex, age at onset of T1D, current age, and migratory background. The primary outcomes oof interest for the study were HbA1c, time spent in range of 70-180 mg/dL, glycemic variability, and hospital admissions, which were assessed using linear, fractional, and logistic regression models. Upon analysis, results indicated tubeless insulin pump users experienced significantly lower mean HbA1c 7.6% (95% CI, 7.5-7.6) compared to those using multiple daily injections (7.8% [95% CI, 7.7-7.8]), P <.001). Further analysis suggested those in the pump group had a higher percentage of time in range (52% [48-56] vs 48% [45-52]; P=.151) than their counterparts using multiple daily injections.⁴

References

1. Highly anticipated Omnipod® 5 real-world evidence to be presented at the 16th International Conference on Advanced Technologies & Treatments for diabetes(attd). Insulet Corporation - Highly Anticipated Omnipod® 5 Real-World Evidence to be Presented at the 16th International Conference on Advanced Technologies & Treatments for Diabetes(ATTD). https://investors.insulet.com/news/news-details/2023/Highly-Anticipated-Omnipod-5-Real-World-Evidence-to-be-Presented-at-the-16th-International-Conference-on-Advanced-Technologies--Treatments-for-DiabetesATTD/default.aspx. Published February 21, 2023. Accessed March 1, 2023.
2. Hughes M. Automated Insulin Delivery for Inpatients with Dysglycemia (AIDING) Feasibility Study. In: Advanced Technologies and Treatments for Diabetes. Berlin; 2023.
3. Soriano E. Who are the Insulin-Using Adults with Type 2 Diabetes Opting to Initiate Pump Therapy? In: Advanced Technologies and Treatments for Diabetes. Berlin; 2023
4. Lanzinger S. IMPROVED GLYCAEMIC CONTROL IN CHILDREN AND YOUNG ADULTS WITH TYPE 1 DIABETES USING TUBELESS INSULIN PUMPS VS MULTIPLE DAILY INJECTIONS IN COMBINATION WITH GLUCOSE SENSORS. In: Advanced Technologies and Treatments for Diabetes. Berlin; 2023.