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

Type 1 Diabetes Clinical Trial

— GLUT  

Official title:

Use of the Glycemic Load for the Adjustment of the Dose of Preprandial Insulin in Patients With Type 1 Diabetes Mellitus in Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978704
• Other study ID #: 37/13
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: November 1, 2013
• Start date: February 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal

• Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily plasma glucose excursion		1 week
Primary	mean plasma glucose concentrations		1 week
Secondary	postprandial plasma glucose concentrations		1 week