Background

Evidence for low-carbohydrate approaches to treat diabetes and obesity are limited by there being few studies on long-term sustainability and patient adherence. We previously showed that a novel digitally-monitored continuous care intervention (CCI) including nutritional ketosis significantly improved weight, glycemic outcomes and lipid profile at 1 year. Here, we assess the maintenance of these gains after 2 years of the CCI.

Methods

Participants with a diagnosis of type 2 diabetes (N=262, 92% obese) were enrolled. At 2 years, 74% continued in the CCI. We used linear mixed-effects models (intent-to-treat analyses) to assess adjusted mean changes from baseline to 2 years on glycemic outcomes, weight, blood pressure, and lipid profiles. McNemar’s test was used to assess changes in diabetes status among those who completed the intervention. Current diabetes was defined as HbA1c ≥6.5% and/or use of medication for glycemic control other than metformin.

Results

Significant changes from baseline to 2 years included: HbA1c -0.94±0.10% (from 7.66±0.09%); fasting glucose -29.1±4.9mg/dL (from 163.7±3.9mg/dL); fasting insulin -11.7±1.2uU/mL (from 27.7±1.3uU/mL); c-peptide-derived HOMA-IR -8.59±0.38 (from 11.14±0.37); weight -11.94±0.96kg (from 114.56±0.60kg); systolic BP -5.8±1.2 mm/Hg (from 131.7±0.9mm/Hg); diastolic BP -3.1±0.7 mm/Hg (from 81.8±0.5mm/Hg); triglycerides -40.7±8.6mg/dL (from 194.1±8.0mg/dL); HDL-C +7.8±0.9mg/dL (from 41.8±0.8mg/dL), and beta-hydroxybutyrate concentrations +0.09±0.02 mmol/L (from 0.18±0.01mmol/L). There was a 43.2% reduction (from 88.0% to 44.8%) in the number of patients meeting the defined criteria for diabetes at 2 years. All the reported improvements had p-values <0.0001.

Conclusions

The CCI has lasting beneficial effects on multiple clinical markers of cardiometabolic health at 2 years, consistent with results at intervention year 1. The intervention is also effective in the long-term resolution of diabetes.