Design of the Continuous Glucose Monitoring (CGM) Study in the Dietary Approaches to Stop Hypertension for Diabetes Trial (DASH4D-CGM)

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-12 DOI:10.1016/j.cct.2025.107845

Dan Wang , Scott Z. Mu , Olive Tang , Justin B. Echouffo-Tcheugui , Christine M. Mitchell , Michael Fang , Mary R. Rooney , Hsin-Chieh Yeh , Casey M. Rebholz , Scott J. Pilla , Lawrence J. Appel , Elizabeth Selvin

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引用次数: 0

Abstract

Background

The Dietary Approaches to Stop Hypertension (DASH) diet is recommended for adults with diabetes. However, the effects of the DASH diet on glucose control and variability have not been thoroughly investigated.

Study aim

To study the effects of a modified DASH diet on glycemic control and glucose variability assessed by continuous glucose monitoring (CGM) in individuals with hypertension and type 2 diabetes.

Methods

We conducted an ancillary study to add CGM to the Dietary Approaches to Stop Hypertension for Diabetes (DASH4D) Trial. The DASH4D Trial was designed to determine the effects, alone and combined, of a modified DASH diet (vs a diet typical of what Americans with diabetes eat) and lower (vs higher) sodium intake on systolic blood pressure among people with type 2 diabetes and elevated blood pressure. Participants were fed each of the 4 study diets for 5 weeks in a random order. We invited all participants enrolling in the DASH4D Trial to wear a masked CGM sensor for up to 14 days during screening and during each of the four 5-week feeding periods. The DASH4D-CGM Study primarily aimed to evaluate the effects of the modified DASH diet (vs comparison diet) on glycemic control (mean glucose and time-in-range) and glucose variability (coefficient of variation).

Conclusion

Combining CGM technology and a controlled feeding design, the DASH4D-CGM Study will generate robust data on the effects of diet on glycemic control and variability. These findings will inform dietary recommendations for adults with type 2 diabetes.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.