METHODS
T1DM, cancer, RCC, Diabetes, depression, heart failure, diabetes‐related distress, diabetes
CANCER, RENAL FAILURE, DIABETES, HEART FAILURE, RCC, DIABETES
We performed an open‐label randomized controlled trial at the Diabetes Clinic of SUMC, a tertiary 1200‐bed hospital that treats a diverse population, including Bedouin and other Arabs, and Jews from the general, ultra‐Orthodox and Ethiopian sectors. Patients with T1DM were eligible for this study if they were (i) over 18 years old, (ii) treated either with an insulin pump or with multiple daily injections of insulin and (iii) had a hemoglobinA1c (A1C) level equal to, or >8.5. The study excluded pregnant or lactating women, patients with severe renal failure, heart failure or under active treatment for cancer. All participants signed an informed consent statement. The study was approved by the SUMC Helsinki Committee on 8 October 2015, approval number 0320‐15, and is registered at Using simple randomization, we assigned participants to one of the two groups, (RCC) Regular carbohydrate counting, or (SCC) simplified individualized tool for carbohydrate counting. The selection process was purely random for every assignment made by Diabetes Clinic staff.All participants were allowed up to six instructional sessions with a registered dietitian who is also a diabetes care and education specialist during a period of about 6 months. All sessions were free of charge and lasted at least 60 min. During the first session, participants were introduced to the carbohydrate counting method to which they were assigned at randomization. Subsequent sessions were dedicated to reinforcing and practicing their method and changes in insulin dosage parameters were made if needed. All patients treated with insulin pumps were encouraged to use the bolus calculator. The primary end‐point was level of A1C 6 months after the intervention. Additional data parameters were collected including those of demographics, education and duration of diabetes. Weight was measured and blood studies were conducted before and after the intervention to determine baseline A1C and lipid levels. In order to identify depression and diabetes‐related distress, the participants were asked to complete the PAID5 questionnaire (Problem Areas in Diabetes Scale‐PAID)