The Effect of Three Different Types of Diet on Glycemia Assessed by Continuous Glucose Monitoring in Patients With Type 1 Diabetes on Multiple Daily Insulin Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Primary Endpoint
- Percentage of time spent with glucose levels between 70-140 mg/dl
Study Overview
Brief Summary
The aim of the present study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).
Detailed Description
The aim of the present crossover study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).
Three different isocaloric diets, namely, a Mediterranean style diet, a low-carbohydrate diet and a reference diet were provided to patients with T1D for three separate weeks, in a random order, and with 7-day washout periods in-between. Glycemia was assessed during each 7-day period using a continuous glucose monitoring system. Participants were recruited from the outpatient diabetes clinic of a University Hospital in Athens, Greece.
The primary outcome was time spent in euglycaemic range (TIR: 70-140mg/dl) during the diet period. Secondary outcomes were: (a) time spent below euglycaemic range (TBR: <70mg/dl); (b) time spent above euglycaemic range (TAR: >140mg/dl); (c) glycaemic variability and (d) insulin needs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults with T1D receiving MDI therapy
- •Sufficient education and knowledge on carbohydrate counting
- •Motivation to follow a specific dietary schedule
- •Frequent (7 times a-day) self-monitoring of blood glucose (SMBG)
- •Willingness to wear a CGM system
Exclusion Criteria
- •HbA1c >8%
- •Lack of severe diabetic complications, such as cardiovascular disease, proliferative retinopathy, nephropathy with estimated glomerular filtration rate (eGFR) ≤ 60 or gastroparesis
Arms & Interventions
Mediterranean diet
Mediterranean diet for 7 days
Intervention: Dietary intervention (Behavioral)
Low-carb/high protein diet
Low-carb/high protein diet for 7 days
Intervention: Dietary intervention (Behavioral)
Reference diet
Reference diet for 7 days
Intervention: Dietary intervention (Behavioral)
Outcomes
Primary Outcomes
Percentage of time spent with glucose levels between 70-140 mg/dl
Time Frame: 7 days
Percentage of time spent with glucose levels between 70-140 mg/dl
Secondary Outcomes
No secondary outcomes reported
Investigators
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens