Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal; Other: Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal

• Registration Number: NCT01978704
• Lead Sponsor: Federico II University

Brief Summary

The aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Last Update Submitted: 2013-11-01
• Study First Posted: 2013-11-07
• Last Update Posted: 2013-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Type 1 diabetes treated by insulin pump

Exclusion Criteria

• Preganncy

• HbA1c > 9%

  • Any serious acute or chronic illness a part diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glycaemic load	Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal	-
Carbohydrates content	Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal	-

Primary Outcome Measures

Name	Time	Method
daily plasma glucose excursion	1 week
mean plasma glucose concentrations	1 week

Secondary Outcome Measures

Name	Time	Method
postprandial plasma glucose concentrations	1 week