Low-carbohydrate Diet in Children With Type 1 Diabetes (Lowca)

Low-carbohydrate Diet in Paediatric Type 1 Diabetes: Effects on Glycaemic Control and Islet Autoimmunity

The primary aim of this pilot study is to test whether low-carbohydrate diet (LCD) instituted in children/adolescents with type 1 diabetes (T1D) can improve their disease control. The primary objective of the trial is the change in continuous glucose monitoring time in target range 3.9-10.0 mmol/l (TIR) in a 5-week period on LCD as opposed to a 5-week period on recommended carbohydrate diet (RCD). Secondary objectives are: Changes in immune parameters during the LCD period; Differences in fecal microbiome during the LCD period; Differences in fecal, serum and urine metabolome during the LCD period;

The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.

The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with 50% (+/- 5%) of the recommended energy from carbohydrates.

The diet will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.

The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with the amount of carbohydrates equal to 45% (+/- 5%) of the recommended energy a day.

Change in continuous glucose monitoring time in target range (3.9-10.0 mmol/l) during the LCD period compared to the RCD period

Changes in mean body weight standard deviation score during the LCD period compared to the RCD period

Changes in muscle strength measured by jumping mechanography during the LCD period compared to the RCD period

Inclusion Criteria: T1D diagnosed according to the ADA (American Diabetes Assocciation) criteria T1D duration for at least 1 year prior to the intervention continuous glucose monitor (CGM) worn > 70% time in the month prior to the intervention Exclusion Criteria: last HbA1c < 40 or > 70 mmol/mol subject has celiac disease daily average carbohydrate intake < 130 g/day from 14 days food record prior to the intervention any concomitant disease possibly affecting glucose control any chronic medication possibly affecting glucose control