AUTHOR=Sterner Isaksson Sofia , Ólafsdóttir Arndís F. , Lind Marcus 

TITLE=Design of a randomized cross-over study evaluating effects of carbohydrate intake on glycemic control in persons with type 1 diabetes

JOURNAL=Frontiers in Nutrition

VOLUME=10

YEAR=2023

URL=https://www.frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1114317

DOI=10.3389/fnut.2023.1114317

ISSN=2296-861X

ABSTRACT=<sec><title>Introduction</title><p>Diet is an important factor in managing glycemic control in type 1 diabetes (T1D). Reducing carbohydrate intake may be important for stabilizing blood glucose levels in certain groups of patients with T1D. There are few studies examining the effects of a low carbohydrate diet in patients with T1D. The aim of this study is to investigate the effects of carbohydrate intake on glucose control in adults with T1D.</p></sec><sec><title>Materials and methods</title><p>Adults with T1D (<italic>N</italic> = 54) and inadequate glycemic control (HbA1c ≥ 7.5%; 58 mmol/mol) were randomized in a cross-over design to a moderate carbohydrate diet (30 percent of total energy from carbohydrates) versus a traditional diabetes diet (50 percent of total energy from carbohydrates) for 4 weeks with a between wash-out period of 4 weeks. Masked continuous glucose monitoring was used throughout the study to evaluate effects on mean blood glucose levels, time-in-range, hypoglycemia, hyperglycemia, and glycemic variability. Diabetes treatment satisfaction, hypoglycemic confidence, and physical activity were measured using questionnaires during different phases of the trial. HbA1c, blood lipids, blood pressure, and ketone levels were also measured. The primary endpoint is the difference in mean blood glucose level between the diet periods. Study completion is anticipated during winter 2022.</p></sec><sec><title>Discussion</title><p>The study seeks to increase knowledge about the effects of dietary carbohydrate intake on glycemic control and other health parameters in patients with T1D. If beneficial effects on mean blood glucose level without elevated risk of hypoglycemia or ketoacidosis are shown, a moderate carbohydrate diet may be a treatment option for people with T1D that have unsatisfactory blood glucose levels.</p><p><bold>Clinical Trials Registration:</bold><ext-link xlink:href="http://www.clinicaltrials.gov" ext-link-type="uri" xmlns:xlink="http://www.w3.org/1999/xlink">www.clinicaltrials.gov</ext-link>, ID: NCT03400618.</p></sec>