Efficacy of a Diabetes Specific Nutrition Supplement on CGM Outcomes in Adults with Type 2 Diabetes: Post Hoc Analysis of an RCT

Abstract

Efficacy of a Diabetes Specific Nutrition Supplement (DSNS) in improving glycemic and gut health markers through an RCT have been reported. A continuous glucose monitoring (CGM) device reports changes in interstitial blood glucose every 15 minutes. This post-hoc analysis elucidated the role of DSNS on the first few days of DSNS consumption. As an exploratory objective, impact of DSNS on fecal metagenomics post 12 weeks supplementation has also been reported. N = 210 adults were randomized to receive either DSNS with standard care (DSNS + SC; n = 105) or standard care alone (SC alone; n = 105). CGM data was obtained from n = 137 participants (DSNS + SC = 68; SC alone = 69) across days. Exploratory outcomes of fecal metagenomic (DSNS + SC = 2) and Short Chain Fatty Acids (SCFAs) (DSNS + SC = 5; SC alone = 5) analysis was carried out in a subsample at baseline and endline. For the DSNS + SC group, incremental area under Curve (iAUC) for first 24 hours (acute blood glucose response) post DSNS consumption reported to be significantly lower [−106 ± 36 mg*15 min/dL; p = 0.01] as compared to iAUC from “no DSNS consumption day”, while SC alone showed no significant differences between the days. When compared between groups, DSNS + SC had a significantly lower iAUC [−106 mg/min∙dl; p = 0.04] versus SC alone. Postprandial (PP) iAUC for day 1 after DSNS consumption as part of breakfast (first serve) was compared to PP iAUC on “no DSNS consumption day”. Within the DSNS + SC, PP iAUC was significantly lower [−99 ± 38 mg*15 min/dL; p = 0.005] vs no consumption. When PP iAUC was compared between groups, DSNS + SC had a significantly lower iAUC [−131 mg/min∙dl; p = 0.02] versus SC alone. After 1 day of DSNS consumption, DSNS + SC showed significantly lower fasting interstitial glucose (FG) [168 ± 10 mg/dl; p = 0.01] versus SC alone [200 ± 11 mg/dl]. Preliminary metagenomic analysis of DSNS + SC indicated improved microbial diversity from baseline to endline. Fecal SCFAs showed no differences (p > 0.05). Basis CGM outcomes (iAUC, PP, FG), benefits on the glycemic response started showing positive effects from the first day and serve of the DSNS. Long term consumption of DSNS is suggested for further improvement of glycemic markers. The preliminary exploratory analysis on gut microbiome indicated encouraging trends towards improved gut health; however, larger studies are necessary to further substantiate this.