DIABRISK-SL trial: further consideration of age and impact of imputations

Abstract

Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality worldwide. Early interventions may help to delay or prevent onset of cardiometabolic endpoints of clinical importance to T2DM patients. Wijesuriya et al. ( BMC Med 15:146, 2017) published results of a randomised controlled trial in Sri Lanka testing the effect of two lifestyle modification programmes of varying intensity in participants aged 5–40 years with risk factors for T2DM. The intervention measured the impact of the two programmes on the primary composite endpoint consisting of various predictors of cardiometabolic disease. The authors concluded that the more intensive programme significantly reduced the incidence of predictors of cardiometabolic disease. Further, they delivered a large-scale intervention with restricted resources with widespread acceptance as demonstrated by the high uptake rate. However, we believe that further analysis is required to fully understand the potential for benefit, particularly in relation to age, retention and missing data.

Reducing the incidence of predictors of cardio-metabolic disease and dysglycaemia with lifestyle modification in at-risk persons – results of further analyses of DIABRISK-SL in those below 18 years of age

“…We appreciate the interest that Gkioni et al [2] have shown in our published study by highlighting the importance of age differentiation, retention and missing data as factors that need to be considered to understand the full potential of the benefits observed in our study. We have outlined below the detailed response to each of these factors and the results of further analyses are also reported.…”

“…Gkioni et al [2] highlight the importance of further subcategory age differentiation as a factor to consider when interpreting the results of the intervention. As detailed in our original publication [1], the results for those below the age of 18 were post hoc and thus exploratory, and establish the platform and rationale for further studies in this population.…”

“…In response to the comment from Gkioni et al [2], we have now performed further post hoc analyses and report the results of the intervention in age differentiated (6–10 years: P-LSM n = 77, C-LSM n = 59; 10–14 years: P-LSM n = 534, C-LSM n = 556; and 14–18 years: P-LSM n = 239, C-LSM n = 260) groups for the 1725 participants (P-LSM n = 850, C-LSM n = 875) aged below 18 years on the primary cardio-metabolic composite endpoint, new onset dysglycaemia (T2DM, IGT, IFG) and selected individual components of the primary composite endpoint (Additional file 1: Table S1). Definitions of the endpoints were as previously described [1].…”

“…Gkioni et al [2] also raise the point that food choices and activity options may be limited in young children and that engagement of their primary carers is key. We agree with this comment and, as reported in our original publication, lifestyle modification advice and guidance (which was focussed on food choices and detailed exercise options) was also given to the parents of younger children (age < 16 years) [1].…”