Different Dietary Interventions and Glycemia in T1DM

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Dietary intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mediterranean diet<br>Mediterranean diet for 7 days | Behavioral: Dietary intervention<br>* Crossover dietary manipulation using three different types of diet for 7 days each<br>|
| Active Comparator: Low-carb/high protein diet<br>Low-carb/high protein diet for 7 days | Behavioral: Dietary intervention<br>* Crossover dietary manipulation using three different types of diet for 7 days each<br>|
| Active Comparator: Reference diet<br>Reference diet for 7 days | Behavioral: Dietary intervention<br>* Crossover dietary manipulation using three different types of diet for 7 days each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent with glucose levels between 70-140 mg/dl | Percentage of time spent with glucose levels between 70-140 mg/dl | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Diabetes Mellitus, Type 1, Glycemia, Continuous glucose monitoring