Carbohydrate Counting vs. Fixed Meal Plan in Indian Children with Type 1 Diabetes Mellitus: A Randomized Controlled Trial.

Objectives: To study the impact of carbohydrate counting vs. fixed-meal plan on glycemic control, quality of life (QoL) and diabetes-related emotional distress in children with Type 1 diabetes mellitus (T1DM).

Methods: Children aged 6-18 y with T1DM of duration >1 y were eligible for the study if they were on multiple daily injections of insulin and regularly monitoring blood glucose. Those with celiac disease, hypothyroidism, any underlying chronic renal/liver/systemic disease or HbA1c >13% were excluded. Both groups received education on diabetes management and healthy diet. In the intervention arm, parents were taught to quantify carbohydrate content and modify insulin doses according to insulin-carbohydrate ratio. The control arm had dietary prescription according to recommended dietary allowance and food exchange list. Standard validated questionnaires were used to assess the QoL and emotional distress related to diabetes.

Results: One hundred twenty five patients (61 intervention, 64 controls) were enrolled and 91.8% and 84.3%, respectively, completed 6-mo follow-up. There was a reduction in HbA1c in both the groups, but was not statistically significant within or between groups {Intervention: 8.9 (1.4) to 8.6 (1.5) vs. control: 9.1 (1.6) to 8.8 (1.9), [95% CI 8.3-9.3 vs. 8.3-9.0, intention to treat (ITT), p = 0.63]}. There was a significant reduction in diabetes distress in the intervention group; DAWN Problem Areas in Diabetes Questionnaire (PAID) score with a median (interquartile range) of 21 (11-33) vs. control: 27 (20-40), (p = 0.04).

Conclusions: Patients in the carbohydrate-counting group demonstrated lower diabetes distress scores and less emotional burnout compared to fixed-meal plan over a 6 mo period though overall glycemic control was comparable between groups.