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Randomized Controlled Trial
. 2024 Mar 15;109(4):1060-1070.
doi: 10.1210/clinem/dgad639.

Lifestyle Intervention With Smartphone App and isCGM for People at High Risk of Type 2 Diabetes: Randomized Trial

Masaru Kitazawa  1 , Yasunaga Takeda  1 , Mariko Hatta  1 , Chika Horikawa  2 , Takaaki Sato  1 , Taeko Osawa  1 , Masahiro Ishizawa  1 , Hiroshi Suzuki  1 , Yasuhiro Matsubayashi  1 , Kazuya Fujihara  1 , Takaho Yamada  1 , Hirohito Sone  1
Affiliations
Randomized Controlled Trial

Lifestyle Intervention With Smartphone App and isCGM for People at High Risk of Type 2 Diabetes: Randomized Trial

Masaru Kitazawa et al. J Clin Endocrinol Metab. .

Abstract

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.

Keywords: continuous blood glucose monitor; educational intervention; prevention; prospective randomized trial; smartphone.

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Figures

Figure 1.
Figure 1.
Screen shots of the Health2Sync app. A, Records of daily activities. B, Continuous glucose monitoring and daily activities. C, Message based on continuous glucose monitoring data. D, Message based on blood pressure data.
Figure 2.
Figure 2.
Use of smartphone applications, isCGM, and retrospective CGM.
Figure 3.
Figure 3.
Flow chart of participants.
Figure 4.
Figure 4.
Changes in glucose variability between the control group and the intervention group. Error bars in the table indicate standard error.
Figure 5.
Figure 5.
Changes in body mass index at weeks 0, 2, 4, 6, 8, 10, and 12. Patients with fasting biochemical data at each time point were included in the analysis. Error bars in the table indicate standard errors.
See this image and copyright information in PMC

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