Management of People with Type 2 Diabetes Shared between a Specialised Outpatient Clinic and Primary Health Care is Noninferior to Management in a Specialised Outpatient Clinic: A Randomised, Noninferiority Trial.

To ensure high-quality care for patients with type 2 diabetes (T2D), it is necessary to consider how clinical management is organized. We investigated if management of patients with T2D shared between a specialized outpatient clinic and primary health care has a non-inferior outcome of HbA1c compared to ‘mono’ management in a specialized outpatient clinic.The study was a 12-month randomized controlled, non-inferiority trial. Non-inferiority margin for HbA1c was 4.4 mmol/mol. Patients with T2D and incipient complications were eligible for the study. The shared care intervention consisted of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at the primary health care physician. The control group was offered four quarterly visits at the outpatient clinic, including an annual comprehensive check-up.We randomized 140 patients (age: 65.0±0.9 years (mean±SEM), BMI: 30.8±0.5 kg/m2, diabetes duration: 9.1±0.5 years, HbA1c: 51.9±0.8 mmol/mol, systolic blood pressure: 135.6±1.1 mmHg) with no significant baseline differences between the groups. Ninety-five (68%) patients had peripheral neuropathy, 26 (19%) microalbuminuria, and 21 (15%) previous major cardiovascular event. At end-of-trial, mean HbA1c change from baseline was 2.0 mmol/mol in the intervention group and 0.9 mmol/mol in the control group. The between-group difference of 1.1 mmol/mol (95% confidence interval: -2.0, 4.1) met the pre-specified non-inferiority criterion. Our study shows that a shared care program is non-inferior to an established program in a specialized outpatient clinic in maintenance of glycemic control of T2D patients with incipient complications. Shared care could be part of future T2D management, as more patients will benefit from the specialized diabetes team while keeping close contact with the primary care physician