Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study.
Level 3 - non-randomized controlled study
Non-randomized controlled cohort study with concurrent usual-care control group
PubMed 29417495 · doi:10.1007/s13300-018-0373-9
What was done
An open-label, non-randomized, controlled, before-and-after 1-year study evaluated a continuous care intervention (CCI, n = 262) versus usual care (UC, n = 87) in 349 adults with type 2 diabetes. The CCI combined continuous remote biometric monitoring, individualized medication management, and dietary carbohydrate restriction targeting nutritional ketosis. Primary outcomes were HbA1c, body weight, and diabetes medication prescriptions. Secondary outcomes included fasting glucose, insulin, HOMA-IR, lipid profiles, liver/kidney biomarkers, and hsCRP.
What was found
In the CCI group, 218 participants (83%) remained enrolled at 1 year. Intention-to-treat analysis showed HbA1c decreased from 7.6 ± 0.09% (59.6 ± 1.0 mmol/mol) to 6.3 ± 0.07% (45.2 ± 0.8 mmol/mol, P < 1.0 × 10^-16) and weight dropped by 13.8 ± 0.71 kg (P < 1.0 × 10^-16). Prescriptions for non-metformin diabetes medications declined from 56.9 ± 3.1% to 29.7 ± 3.0% (P < 1.0 × 10^-16), with insulin reduced or eliminated in 94% of users and sulfonylureas discontinued in all users. HOMA-IR decreased 55% (P = 3.2 × 10^-5), hsCRP decreased 39% (P < 1.0 × 10^-16), triglycerides decreased 24% (P < 1.0 × 10^-16), HDL-C rose 18% (P < 1.0 × 10^-16), LDL-C rose 10% (P = 5.1 × 10^-5), and apolipoprotein B was unchanged (P = 0.37). Serum creatinine and liver enzymes (ALT, AST, ALP) declined (P <= 0.0001). No adverse events were attributed to the CCI. Usual care participants experienced no significant biomarker or medication changes.
Why it matters
This study shows that continuous remote support paired with nutritional ketosis can safely reverse glycemic markers and substantially deprescribe diabetes medications in adults with type 2 diabetes.
Limits
The study lacked randomization and blinding, introducing substantial risk of participant self-selection bias and motivational confounding. Seventeen percent of intervention participants dropped out before 1 year, and long-term cardiovascular implications of the observed 10% increase in LDL-C remain unmeasured.
Cited by
- supports In a one-year study by Dr. Sarah Hallberg, patients achieved restoration of insulin sensitivity, medication reduction, and discontinuation of sulfonylureas across the entire interventional group.
- supports In a clinical trial by Dr. Sarah Hallberg testing a ketogenic diet for type 2 diabetes, 96% of participants reduced or discontinued insulin, 100% discontinued sulfonylureas, and average weight loss was 14% of body weight.