Masaru Kitazawa, Yasunaga Takeda, Mariko Hatta, Chika Horikawa, Takaaki Sato, Taeko Osawa, Masahiro Ishizawa, Hiroshi Suzuki, Yasuhiro Matsubayashi, Kazuya Fujihara, Takaho Yamada, Hirohito Sone
Journal: The Journal of clinical endocrinology and metabolism 2024;109(4):1060-1070
PMID: 37931069
Diabetes mellitus is a risk factor for cardiovascular disease and has been associated with 2- to 4-fold higher mortality than in those without diabetes. Intermittently scanned continuous glucose monitoring (isCGM), which is minimally invasive, is used to manage diabetes. Monitoring blood glucose with isCGM not only provides health care providers with information but patients with appropriate feedback on diet, exercise, and medications. This study’s aim was to investigate the effectiveness of a lifestyle intervention programme, that combines lifestyle coaching via a smartphone application with isCGM, for blood glucose control and body weight reduction in people at high risk of type 2 diabetes. This study was a 12-week prospective, randomised, unblinded 1-to-1 allocation trial. Participants were randomly assigned to either the intervention group (using the smartphone app) or the control group. Results showed that: - the intervention group showed significant improvement in time spent in the target blood glucose range. - time below the range (blood glucose <70 mg/dL) improved in the intervention group. - body mass index reduction was observed in the intervention group compared to the control group. Authors concluded that a lifestyle intervention using isCGM and a smartphone app improved glycaemic fluctuations and increased weight loss in people at high risk of type 2 diabetes. However, further studies are needed to confirm whether these interventions can prevent the incidence of type 2 diabetes.
AIMS
Although conventional interventions for people at high risk of developing type 2 diabetes are usually conducted face-to-face, such interventions are burdensome for health care providers. We developed a lifestyle intervention program combining lifestyle coaching via a smartphone application augmented by intermittently scanned continuous glucose monitoring without burdening health care providers. Its effectiveness for glycemic control and body weight reduction in people at risk of type 2 diabetes was investigated.
MATERIALS AND METHODS
For this 12-week randomized unblinded trial with offline recruitment, participants with a hemoglobin A1c level of 5.6% to 6.4% or a fasting blood glucose of 110 to 125 mg/dL and body mass index (BMI) >23 kg/m2 but <40 kg/m2 were randomly assigned to the intervention group (App) and control group (C). The primary endpoint was the difference in time in range of blood glucose between 70 and 140 mg/dL (3.9-7.8 mmol/L) before and after the study period between the 2 groups.
RESULTS
Among 168 patients (mean age, 48.1 years; mean BMI, 26.6 kg/m2; and male, 80.4%), 82 and 86 were assigned to the App group and C group, respectively. After 12 weeks, time in range of blood glucose at 70 to 140 mg/dL significantly improved in the App group compared with the C group (-2.6 minutes/day vs +31.5 minutes/day, P = .03). Changes in time above range did not differ, whereas time below range (blood glucose <70 mg/dL; +23.5 minutes/day vs -8.9 minutes/day, P = .02) improved in the App group. BMI (-0.26 vs -0.59, P = .017) was reduced in the App group compared with the C group.
CONCLUSION
Intervention with a smartphone app and intermittently scanned continuous glucose monitoring increased glycemic control accompanied by decreased carbohydrate intake and weight loss. Further trials are needed to confirm whether these interventions can reduce incident type 2 diabetes.
© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.
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