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

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.