CClinicalTrials.gg
CompletedNCT01978704GLUTUpdated Nov 7, 2013

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

An interventional study of Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal and Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal in Type 1 Diabetes, sponsored by Federico II University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-07.

Sponsored by Federico II University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 9 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

Inclusion criteria

  • Type 1 diabetes treated by insulin pump

Exclusion criteria

Exclusion Criteria:

  • Preganncy
  • HbA1c > 9%

    • Any serious acute or chronic illness a part diabetes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Glycaemic load

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

  • Active comparator
    Carbohydrates content

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

Interventions

  • OtherAdjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal
  • OtherAdjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal
06

What researchers measure

Primary outcomes

  1. daily plasma glucose excursion

    Time frame: 1 week

  2. mean plasma glucose concentrations

    Time frame: 1 week

Secondary outcomes

  1. postprandial plasma glucose concentrations

    Time frame: 1 week

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01978704
Lead sponsor
Federico II University
Responsible party
rivellese angela (Prof, Federico II University) — Principal investigator
First posted
Nov 7, 2013
Start date
Feb 2013
Primary completion
Jul 2013
Completion
Aug 2013
Last update
Nov 7, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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