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

NCT ID: NCT01978704

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glycaemic load

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Carbohydrates content

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes treated by insulin pump

Exclusion Criteria

* Preganncy
* HbA1c \> 9%

* Any serious acute or chronic illness a part diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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rivellese angela

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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37/13

Identifier Type: -

Identifier Source: org_study_id