A groundbreaking five-year study reveals that a low-carbohydrate diet, paired with continuous remote care, helps people with type 2 diabetes achieve long-lasting remission and dramatically reduce their medication use.
Study: 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study. Image Credit: Stokkete / Shutterstock
In a recent study published in the journal Diabetes Research and Clinical Practice, researchers evaluated a telemedicine intervention aiming to help people with type 2 diabetes (T2D) follow a very low-carbohydrate diet to achieve nutritional ketosis.
Their findings indicate that the intervention showed high retention levels, resulting in significant health improvements over five years, including weight loss, increased HDL cholesterol by 17.4%, decreased triglycerides by 18.4%, reduced inflammation markers such as a 43.6% drop in high-sensitivity C-reactive protein (hs-CRP), improved cardiometabolic health, and diabetes remission.
Background
T2D has traditionally been seen as a progressive, chronic disease, but new evidence suggests that therapies can reverse it, lowering glycated hemoglobin (HbA1c) levels and reducing the need for glucose-lowering medications.
Eventually, this could lead to sustained and medication-free remission, defined as having glycated hemoglobin levels lower than 6.5% for three months or more without glucose-lowering drugs.
Remission is associated with significant health benefits in the long term, as hyperglycemia is linked to increased risks of complications associated with diabetes. Methods to achieve remission include insulin therapy, surgery, and nutrition-related therapies that significantly restrict carbohydrate or caloric intake.
Restricting carbohydrates may improve cardiovascular health and blood sugar control, but studies have primarily considered two-year periods.
About the study
In this study, researchers aimed to examine the long-term effects of a telemedicine intervention, focusing on diabetes status, blood sugar levels, weight, medications, and cardiometabolic health.
The study participants were people with T2D and a body mass index (BMI) greater than 25. They were first recruited for a study comparing continuous care interventions (CCI) with usual care (UC) for two years, while those in the CCI group were offered a three-year continuation at the end of the study.
Out of the 194 CCI participants, 169 continued. The intervention was provided online, with no in-person meetings. The CCI was delivered remotely through an app, providing nutrition counseling and diabetes medication management through telemedicine.
The app guided participants to adhere to a restricted carbohydrate diet (less than 30 grams daily) to attain and maintain nutritional ketosis. The app allowed participants to track weight, blood glucose, and beta-hydroxybutyrate (BHB) while interacting with health coaches and physicians. Participants could also join a peer support community within the app.
Medication deprescription was managed, with metformin only removed if there were contraindications or intolerance. Measurements were taken at the start of the study and after one, two, three-and-a-half, and five years, when inflammation markers, weight, and blood tests were collected.
Findings
Participants who continued into the five-year study were, on average, 54.2 years old, and nearly 68% were female. There were no significant differences in baseline characteristics between those who completed the five years and those who dropped out.
After five years, 20% of the participants had achieved diabetes remission, with 32.5% having glycated hemoglobin levels lower than 6.5% without medication or only metformin. Among those in remission at two years, 57.6% remained in remission at five years, suggesting the durability of the intervention’s effects.
Sustained improvements were noted in several health markers, including a 0.3% reduction in HbA1c, 7.6% weight loss, and a 30.6% decrease in fasting insulin levels. Furthermore, inflammation markers such as hs-CRP saw a 43.6% reduction, and HDL cholesterol increased by 17.4%. These improvements were achieved despite a significant reduction in the use of diabetes medications.
Slightly over 61.3% of the participants achieved 5% weight loss, and nearly 40% sustained 10% weight loss. Remission-associated factors included lower fasting insulin, better adherence, weight loss, less potent diabetes medications, and shorter diabetes duration.
During the study, the use of diabetes medication decreased from 85.2% to 71.3%, while the use of medications other than metformin reduced from 55.7% to 32.8%. The mean daily insulin dose dropped significantly from baseline.
Statistical Analysis
The study used a variety of statistical models to assess changes over five years. Linear mixed-effects models were employed to account for within-subject correlations over time, adjusting for covariates such as age, sex, and diabetes duration. HbA1c, weight, fasting insulin, and cardiovascular markers were analyzed across five time points (baseline, one, two, three-and-a-half, and five years) to capture longitudinal trends. The statistical significance of the changes was confirmed, with adjusted p-values showing notable reductions in fasting insulin, inflammation markers, and lipid profiles, indicating that the intervention’s benefits were robust and sustained.
Comparison to Other Studies
The study’s remission rates exceeded those of other well-known lifestyle therapy trials. For example, the Look AHEAD trial achieved a 7.3% remission rate over four years, while the DiRECT trial reported a 13% remission rate at five years. In comparison, 20% of participants in this study reached remission at five years, with 32.5% achieving HbA1c levels below 6.5% without medication or only metformin. The higher rate of sustained remission in this study may be due to the sustained carbohydrate restriction and the ongoing support provided by the care team.
Conclusions
The study indicates that carbohydrate-restricted therapy with continuous remote care can achieve and sustain T2D remission, with 20% of participants achieving remission after five years and 15 out of 24 maintaining remission for four years. 32.5% of participants achieved reversal without medication or only using metformin. Even participants who did not achieve remission still showed stable blood sugar levels and reduced medication use.
The sustained reductions in HbA1c, fasting insulin, and inflammation markers highlight the effectiveness of this approach in reducing long-term health risks. Additionally, the reduction in medication burden, with a 40% decrease in the medication effect score, further demonstrates the intervention’s clinical value.
Remote care, peer support, access to a care team, and clinical success contributed to high retention. 47% of participants remained in the program for five years with improved blood sugar, body weight, and cardiovascular health. Cardiovascular health improvements were also sustained after five years, and inflammatory markers significantly decreased over this time, reducing cardiovascular risk.
Diabetes management typically increases medication use, but this study showed a reduced need for medication, and some participants were able to achieve complete deprescription. Remission rates achieved in this study exceeded those in other lifestyle therapy trials.
The strengths of this study include the long duration and broad applicability for people with T2D, not just those newly diagnosed. However, there was no comparison group over the entirety of the five years, and limited racial diversity among the participants.
Journal reference:
- 5-Year effects of a novel continuous remote care model with carbohydrate-restricted nutrition therapy including nutritional ketosis in type 2 diabetes: An extension study. McKenzie, A.L., Athinarayanan, S.J., Van Tieghem, M.R., Volk, B.M., Roberts, C.G.P., Adams, R.N., Volek, J.S., Phinney, S.D., Hallberg, S.J. Diabetes Research and Clinical Practice (2024). DOI: 10.1016/j.diabres.2024.111898,
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