Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial

Document Type

Article

Publication Date

2-3-2025

Publication Title

JAMA Netw Open

Keywords

Humans, Diabetes Mellitus, Type 2, Female, Middle Aged, Male, Insulin, Adult, Hypoglycemic Agents, Glycated Hemoglobin, Aged, Insulin Infusion Systems, Prospective Studies, Adolescent, Young Adult, Blood Glucose

Abstract

IMPORTANCE: There is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important.

OBJECTIVE: To evaluate the association of AID with hemoglobin A1c (HbA1c) levels in a diverse cohort of adults with type 2 diabetes.

DESIGN, SETTING, AND PARTICIPANTS: This single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024.

INTERVENTION: Participants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase.

MAIN OUTCOMES AND MEASURES: Primary outcome was change in HbA1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline.

RESULTS: Among 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using basal insulin without bolus, 17 (6%) were using an insulin pump, 188 (62%) were using continuous glucose monitoring, 168 (55%) were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 134 (44%) were using sodium-glucose transport protein 2 inhibitors (SGLT-2is). Following AID use, HbA1c levels decreased from a mean (SD) of 8.2% (1.3) at baseline to 7.4% (0.9) at 13 weeks (mean difference, -0.8 [95% CI, -1.0 to -0.7] percentage points; P <  .001 for noninferiority and superiority). Improvement was seen across various subgroups (age, sex, race and ethnicity, insurance), and notably with or without use of GLP-1RAs or SGLT-2is and regardless of pretrial mealtime insulin regimen. Time in target glucose range (70-180 mg/dL) increased from a mean (SD) of 45% (25) to 66% (17) (mean difference, 20 [95% CI, 18 to 22] percentage points; P <  .001). Percentage of time in hypoglycemic ranges of less than 54 mg/dL and less than 70 mg/dL was noninferior compared with standard therapy. There was 1 episode of severe hypoglycemia and none of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.

CONCLUSIONS AND RELEVANCE: In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation, suggesting that AID may be a beneficial and safe option for people with type 2 diabetes using insulin.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05815342.

Medical Subject Headings

Humans; Diabetes Mellitus, Type 2; Female; Middle Aged; Male; Insulin; Adult; Hypoglycemic Agents; Glycated Hemoglobin; Aged; Insulin Infusion Systems; Prospective Studies; Adolescent; Young Adult; Blood Glucose

PubMed ID

39951268

Volume

8

Issue

2

First Page

2459348

Last Page

2459348

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