NCT01978704

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

November 1, 2013

Last Update Submit

November 1, 2013

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

  • daily plasma glucose excursion

    1 week

  • mean plasma glucose concentrations

    1 week

Secondary Outcomes (1)

  • postprandial plasma glucose concentrations

    1 week

Study Arms (2)

Glycaemic load

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

Carbohydrates content

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

Interventions

Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the mealOTHER
Glycaemic load
Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the mealOTHER
Carbohydrates content

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes treated by insulin pump

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 7, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

November 7, 2013

Record last verified: 2013-11