Different Dietary Interventions and Glycemia in T1DM

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04343131

Enrollment

Registered

2020-04-13

Start date

2014-11-30

Completion date

2017-11-30

Last updated

2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1, Glycemia, Continuous glucose monitoring, Diet

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.

Interventions

BEHAVIORALDietary intervention

Crossover dietary manipulation using three different types of diet for 7 days each

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026