Observational assessments of the relationship of dietary and pharmacological treatment on continuous measures of dysglycemia over 24 hours in women with gestational diabetes

Abstract

Objectives: Studies that use continuous glucose monitoring (CGM) to monitor women with gestational diabetes (GDM) highlight the importance of managing dysglycemia over a 24-hour period. However, the effect of current treatment methods on dysglycemia over 24-hrs are currently unknown. This study aimed to characterise CGM metrics over 24-hrs in women with GDM and the moderating effect of treatment strategy. Methods: Retrospective analysis of CGM data from 128 women with GDM in antenatal diabetes clinics. CGM was measured for 7-days between 30-32 weeks gestation. Non-parametric tests were used to evaluate differences of CGM between periods of day (morning, afternoon, evening, and overnight) and between treatment methods (i.e., diet alone or diet+metformin). Exploratory analysis in a subgroup of 34 of participants was performed to investigate the association between self-reported macronutrient intake and glycaemic control. Results: Glucose levels significantly differed during the day (i.e., morning to evening; P<0.001) and were significantly higher (i.e., mean blood glucose and AUC) and more variable (i.e., SD and CV) than overnight glucose levels. Morning showed the highest amount of variability (CV; 8.4% vs 6.5%, P<0.001 and SD; 0.49 mmol/L vs 0.38 mmol/L, P<0.001). When comparing treatment methods, mean glucose (6.09 vs 5.65 mmol/L; P<0.001) and AUC (8760.8 vs 8115.1 mmol/L.hr; P<0.001) were significantly higher in diet+metformin compared to diet alone. Finally, the exploratory analysis revealed a favourable association between higher protein intake (+1SD or +92 kcal/day) and lower mean glucose (-0.91 mmol/L p, P=0.02) and total AUC (1209.6 mmol/L.h, P=0.021). Conclusions: Glycemia varies considerably across a day, with morning glycemia demonstrating greatest variability. Additionally, our work confirms that individuals assigned to diet+metformin have greater difficulty managing glycemia and results suggest that increased dietary protein may assist with management of dysglycemia. Future work is needed to investigate the benefit of increased protein intake on management of dysglycemia.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was funded by The University of Leeds Studentship (CFD) and the Wellcome Trust (217446/Z/19/Z; MAZ).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the Yorkshire and Humber Regional Ethics Committee (13/YH/0268) and NHS Health Research Authority (NRES) Committee South Central Oxford C (14/SC/1267).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present work are contained in the manuscript.

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