May 1, 2019
December 17, 2019
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.
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.
|Experimental: Study intervention
Other: Low carbohydrate diet
The study intervention will be an eucaloric low carbohydrate diet (15-20 % of carbohydrates) for 2 weeks.
|Active Comparator: Control intervention
Other: balanced diet
The control intervention will be a energy-matched balanced diet (50 % of carbohydrates) for 2 weeks.
- Female and male subjects aged 18 years or older
- Diabetes mellitus Type 1 as definded by WHO for at least 2 years or C-peptide negative
( 4 mmol/L)
- hybrid-closed-loop Insulin therapy (Minimed 670G) for at least 2 months
- HbA1c 3 units/day for men, > 2 units/day for women)
- Pregnancy, planned pregnancy or breast feeding
- Current participation in another clinical trial
- Total daily insulin dose >2 IU/kg/day
- Hereditary dyslipidemia
- Liver steatosis
Contact: Lia Bally, MD PhD +41 (0)31 632 36 77 firstname.lastname@example.org
University Department of Endocrinology, Diabetology, Clinical Nutrition and Metabolism
University Hospital Inselspital, Berne
Principal Investigator: Lia Bally, MD PhD Inselspital, Bern University Hospital, University of Bern