Real-Time AI-Assisted Insulin Titration System for Glucose Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

IMPORTANCE

Type 2 diabetes (T2D) is one of the most prevalent chronic diseases in the world. Insulin titration for glycemic control in T2D is crucial but limited by the lack of personalized and real-time tools.

OBJECTIVE

To examine whether an artificial intelligence-based insulin clinical decision support system (iNCDSS) for glycemic control in hospitalized patients with T2D is noninferior to standard insulin therapy administered by senior physicians.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, single-blind, parallel randomized clinical trial (RCT) was conducted between October 1, 2021, and September 8, 2022, in endocrinology wards of 3 medical centers. Eligible participants were adults (aged ≥18 years) with glycated hemoglobin levels between 7.0% and 11.0% who had received antidiabetic treatments in the previous 3 months.

INTERVENTIONS

Participants were randomized in a 1:1 ratio to receive insulin dosage titration by iNCDSS or senior endocrinology physicians for 5 consecutive days.

MAIN OUTCOMES AND MEASURES

The primary outcome was the proportion of time in the target glucose range (70-180 mg/dL) during the 5-day study period; the noninferiority margin was 6 percentage points. Secondary outcomes included other glycemic control measurements and adverse events.

RESULTS

A total of 149 participants (mean [SD] age, 64.2 [12.0] years; 84 male [56.4%]) were enrolled and randomized to the iNCDSS group (n = 75) or physician group (n = 74). The mean (SD) target glucose range (primary outcome) was 76.4% (16.4%) in the iNCDSS group and 73.6% (16.8%) in the physician group, which achieved the prespecified noninferiority criterion (estimated treatment difference, 2.7%; 95% CI, -2.7% to 8.0%). There were no significant differences in adverse events between the 2 groups. Most physicians were satisfied with the iNCDSS for its clear, time-saving, effective, and safe clinical support.

CONCLUSIONS AND RELEVANCE

In this RCT of an iNCDSS, the system demonstrated noninferiority to senior endocrinology physicians in insulin titration in an inpatient setting, indicating its potential as a favorable tool for insulin titration in patients with T2D.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04642378.