Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study

Abstract

Objective: To investigate the effects of patient-driven lifestyle modification using intermittently scanned continuous glucose monitoring (isCGM) in patients with type 2 diabetes (T2D).

Research design and methods: We conducted a 12-week, open-label, randomized controlled trial. A total of 126 participants were 1:1 randomized to either the intervention group (structured education + isCGM) or the control group (standard care with blood glucose monitoring). The Self-Evaluation Of Unhealthy foods by Looking at postprandial glucose (SEOUL) algorithm was developed and applied to aid structured education in guiding patients to follow healthy eating behavior depending on the postprandial glycemic response. The primary end point was the change in HbA1c level from baseline.

Results: Implementation of the SEOUL algorithm with isCGM was associated with greater improvement in HbA1c than with standard care (risk-adjusted difference -0.50%, 95% CI -0.74 to -0.26, P < 0.001). Participants in the intervention group had a greater reduction in fasting blood glucose and body weight (-16.5 mg/dL, 95% CI -30.0 to -3.0, P = 0.017; -1.5 kg, 95% CI -2.7 to -0.3, P = 0.013, respectively). The score sum for the Korean version of the revised Summary of Diabetes Self-Care Activities Questionnaire increased in both groups but to a greater extent in the intervention group (mean difference 4.8, 95% CI 1.7-8.0, P = 0.003). No severe hyperglycemia or hypoglycemia was reported in either group of patients.

Conclusions: Patient-driven lifestyle modification primarily focused on eating behavior using isCGM effectively lowered HbA1c levels in patients with T2D.

Trial registration: ClinicalTrials.gov NCT04932928.

© 2022 by the American Diabetes Association.

Figures

Figure 1

The SEOUL algorithm. Participants are encouraged to continue eating a healthy meal with tolerable glycemic response after consuming the food and should avoid an unhealthy meal that provokes postprandial hyperglycemia. If hyperglycemia is detected after consuming a meal that is generally considered to be healthy, reducing the amount of food is recommended; the amount of unhealthy food should also be reduced even if it does not generate hyperglycemia on ingestion. Decisions on lifestyle modification will be made on an individual basis according to the SEOUL algorithm.

Figure 2

Consort diagram.

Figure 3

Glycemic outcome according to treatment groups. A: Box plot of HbA1c (%) in the intervention and control groups at V1 and V2. HbA1c levels were significantly decreased in the intervention group at 12 weeks. B: Cumulative distribution of HbA1c (%) levels at V1. C: Cumulative distribution of HbA1c (%) levels at V2. *P < 0.05, **P < 0.01, ***P < 0.001. ns, not significant.