Effectiveness and Safety of the TRIO Optimal Health Management Program in Patients with Type 2 Diabetes Mellitus (T2DM) Initiating Basal Insulin Therapy: Real-World Study.

Abstract

Background: Diabetes, a chronic disease necessitating long-term treatment and self-management, presents significant challenges for patients who spend most of their treatment time outside of hospitals. The potential of digital therapeutics for diabetes has garnered recognition from different organizations. Although some prior studies have demonstrated successful reductions in patients' blood glucose levels and body weight through digital diabetes programs, many studies were limited by including prediabetes patients, patients treated with mostly premixed insulin, or evaluating user engagement outcomes rather than clinical outcomes. Consequently, limited evidence remains regarding the effectiveness of health management mobile applications specifically designed for T2DM patients initiating BI (basal insulin). Based on this, a data-based and artificial intelligence management system named TRIO was developed to provide patients with more personalized intervention methods in stages, groups, and around the clock. TRIO assists doctors and nurses in achieving better blood glucose controls, truly carries out standardized management around patients, and allows them to have a higher quality of life. TRIO represents the three essential pillars in comprehensive diabetes management: physician, nurse, and patient.

Objective: This prospective observational study evaluated the effectiveness and safety of the TRIO optimal health management program for patients with type 2 diabetes mellitus (T2DM) initiating basal insulin therapy in a real-world setting.

Methods: Patients aged 18 to 85 with inadequate glycemic control (baseline HbA1c ≥7.0%) starting basal insulin therapy were enrolled in outpatient and inpatient settings. The study was 3 months, with health education and phone-based follow-up assessments. Data collected included patient characteristics, medical history, baseline diabetes conditions, treatment compliance, glycemic control, and safety indicators.

Results: A total of 199,431 patients were included, and 118,134 patients completed the 3-month follow-up between Dec 1, 2019, and Dec 31, 2021, involving 574 hospitals in China. The mean baseline HbA1c was 9.2%, the mean duration of diabetes was 7.3 years, and 80.4% of patients were using basal insulin with oral antihyperglycemic drugs. After the intervention, mean HbA1c decreased by -2.59% from baseline, with 55.6% achieving the target HbA1c level of <7.0%. Patients who set lower fasting plasma glucose (FPG) goals (<6.1 mmol/L) showed more significant HbA1c reductions and higher target achievement compared to those with FPG goals≥6.1 mmol/L. Factors such as complications, diabetes duration, and baseline HbA1c levels influenced the magnitude of HbA1c reduction. The presence of complications, shorter diabetes duration, and higher baseline HbA1c were significantly associated with increased hypoglycemia incidence risk.

Conclusions: The TRIO optimal health management program effectively improved glycemic control in patients with T2DM initiating basal insulin therapy. Individualized treatment approaches considering patient characteristics and glycemic goals are vital for optimal outcomes.

Clinicaltrial: This real-world study was approved by the Ethics Committee of Nanjing Drum Tower Hospital (IRB Review Approval Document, Code: 2019-231-01).