Administration of a diabetes-specific formula can improve postprandial glycemic control and delay insulin use in gestational diabetes mellitus: A randomized controlled trial from two centers.

BACKGROUND AND AIMS: There have been limited studies on the application of a diabetes-specific formula in gestational diabetes mellitus (GDM), the role of which has not been well studied. We explored the effect of a diabetes-specific formula on blood glucose levels, insulin use and pregnancy outcomes in GDM patients.

METHODS

In this randomized controlled study, 112 GDM patients were randomly assigned to the intervention group (56) and the control group (56). Both groups received individualized dietary counseling. The intervention group consumed a soy-protein-based, high-monounsaturated-fatty-acid, and multi-fiber diabetes-specific formula as milk replacement for breakfast and an extra meal after dinner. All participants were followed up every two weeks until delivery. The blood glucose levels, insulin use and pregnancy outcomes between the groups were compared.

RESULTS

Compared to the control group, the intervention group had significantly lower 2h postprandial blood glucose levels after breakfast (5.84 ± 0.56 vs. 6.15 ± 0.44 mmol/L, p = 0.008), and exhibited higher postprandial time in range values (83.80 % vs. 78.95 %, p = 0.045). The intervention group used insulin later (33 vs. 28 weeks, p = 0.015) and for fewer days (36 vs 78 days, p = 0.024), but no differences in the proportion, dose or frequency of insulin use between the groups. There were no significant differences in pregnancy outcomes between the groups.

CONCLUSIONS

The diabetes-specific formula significantly decreased postprandial blood glucose levels and improved postprandial glycemic control in GDM patients. Moreover, it delayed the initiation of insulin use and reduced the duration of insulin therapy. Our findings may offer a potential new approach for achieving better personalized blood glucose control in GDM patients.

REGISTRATION NUMBER OF CLINICAL TRIAL: NCT03957603 (registered at ClinicalTrials.gov).