A functional medicine approach to diabetes control and quality of life: an open-label randomized pilot study

• First randomized trial comparing a functional medicine (FM) approach, including individualized lifestyle interventions and dietary supplements, with usual care (UC) to just UC in insulin-dependent type 2 diabetes (T2D). • FM added to UC did not significantly improve the primary outcome of insulin discontinuation without increasing HbA1c or HbA1c < 7% at 12 months. • Secondary and exploratory outcomes including BMI, quality of life scores, hypoglycemia, and medication burden, showed no significant differences between FM and usual care at any point in 24 month follow up. • Study highlights real-world adherence challenges to complex FM regimens and their relevance in T2D management. There has been increasing public interest in a functional medicine (FM) approach to the care of type 2 diabetes (T2D). However, it is unclear if this approach can further improve diabetes management beyond conventional diabetes care. This study compared the addition of a FM approach (intensive lifestyle modifications and tailored dietary supplements) plus usual care (FM) to conventional endocrinology management alone (usual care, UC). In a 24-month unblinded randomized trial, participants with type 2 diabetes (T2D) were randomized to receive either FM or UC. The primary endpoint was discontinuation of insulin with no increase in HbA1c or HbA1c < 7% at 12 months. Secondary endpoints included changes in HbA1c, insulin dosage by weight, cardiometabolic biomarkers, hypoglycemic episodes, total number of medications and quality-of-life scores. A total of 107 individuals were screened − 34 were randomized into FM and 37 into UC. Participants were 46% female and median age was 62 years. Median baseline HbA1c was 7.75%. Of those randomized, 47 participants completed the study (FM: 20; UC: 27); 15.8% of patients in FM arm achieved the primary endpoint compared to 11.1% in the UC arm (p = 0.68). Secondary exploratory endpoints including change in HbA1c, insulin dosage by weight, hypoglycemia, BMI, weight and quality-of-life did not differ significantly between arms. The addition of FM did not lead to significant improvement in glycemic, metabolic or quality-of-life outcomes compared to usual care for individuals with type 2 diabetes.