Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes (HiLo12)

Hvidovre University Hospital

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Other: High carbohydrate diet

Other: Low carbohydrate diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02888691

HiLo12

Details and patient eligibility

About

The aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 diabetes ≥3 years
Insulin pump use ≥1 year
HbA1c ≥53 mmol/mol (7.0%)
BMI 20-27 kg/m2
Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
Willingness to use continuous glucose monitoring consistently during the intervention periods

Exclusion criteria

Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
Use of SGLT-2-inhibitors
Use of corticosteroids during or within 30 days prior to the intervention periods
Celiac disease
Inflammatory bowel disease
Macroalbuminuria
Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
Known or suspected alcohol or drug abuse
Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation