Looping Whilst Restricting Carbohydrates (LINEAR)

Insel Gruppe AG, University Hospital Bern

Status

Withdrawn

Conditions

Diabetes

Type 1 Diabetes

Treatments

Other: Low carbohydrate diet

Other: balanced diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03932630

LINEAR

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 (<100 pmol/L with concomitant blood glucose > 4 mmol/L)
hybrid-closed-loop Insulin therapy (Minimed 670G) for at least 2 months
HbA1c <= 9 %
The subject is willing and capable of adhering to the diet plan.

Exclusion criteria

Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
Excess alcohol consumption (> 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
Nephrolithiasis
Hereditary dyslipidemia
Liver steatosis