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Clinical Trials/NCT01978704
NCT01978704CompletedNot Applicable

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

Federico II University0 sites9 target enrollmentStarted: February 1, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
9
Primary Endpoint
daily plasma glucose excursion
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Type 1 diabetes treated by insulin pump

Exclusion Criteria

  • •Preganncy
  • •HbA1c > 9%
  • •Any serious acute or chronic illness a part diabetes

Outcomes

Primary Outcomes

daily plasma glucose excursion

Time Frame: 1 week

mean plasma glucose concentrations

Time Frame: 1 week

Secondary Outcomes

  • postprandial plasma glucose concentrations(1 week)

Investigators

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

rivellese angela

Prof

Federico II University

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