Looping Whilst Restricting Carbohydrates — LINEAR  

Diabetes Clinical Trial

Official title: Looping Whilst Restricting Carbohydrates (LINEAR) - a Randomised Two-Period Crossover Trial

Status Withdrawn

Clinical Trial Summary

To investigate the efficacy, safety and utility of hybrid closed-loop glucose control during a low carbohydrate vs. iso-energetic balanced diet in individuals with type 1 diabetes.

Clinical Trial Description

Closed-loop systems combining an insulin pump, a glucose sensor and a dosing algorithm that adjusts insulin delivery in a glucose-responsive manner achieve significantly better glucose control than conventional therapy in type 1 diabetes. Achieving satisfactory postprandial glucose control, however, continues to be challenging. The main limitation is the delayed pharmacokinetics and -dynamics of subcutaneously administered insulin with peak actions between 1 and 2 hours. Conversely, glucose levels typically rise within 10minutes following carbohydrate intake. This mismatch largely explains the inability of current closed-loop systems to control postprandial glucose excursions and the increased risk of late postprandial hypoglycaemia in response to both user-derived meal bolus administration and reactive algorithm-driven insulin infusion.

Restricting carbohydrate may therefore significantly improve post-prandial glucose control whilst reducing hypoglycaemia. The efficacy of hybrid closed-loop operation in individuals with type 1 diabetes adhering to a low carbohydrate compared to a iso-caloric balanced diet has not been investigated to date. ;

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Type 1 Diabetes

• NCT number: NCT03932630
• Study type: Interventional
• Source: University Hospital Inselspital, Berne
• Status: Withdrawn
• Phase: N/A
• Start date: December 2019
• Completion date: December 2020