Suspended
Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes
What is being tested
Observation of hypoglycemias frequency 3 days before and after pump initiation
Other
Who is being recruted
Autoimmune Diseases+5
+ Diabetes Mellitus
+ Endocrine System Diseases
Until 18 Years
+7 Eligibility Criteria
How is the trial designed
Interventional
Study Start: April 2013
Summary
Principal SponsorSt. Justine's Hospital
Study ContactPatricia Olivier, MDMore contacts
Last updated: April 26, 2013Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.The purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.
Principal SponsorSt. Justine's Hospital
Study ContactPatricia Olivier, MDMore contacts
Last updated: April 26, 2013Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Until 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Autoimmune DiseasesDiabetes MellitusEndocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 1
Criteria
4 inclusion criteria required to participate
Informed and signed consent
Last HbA1c between 7.2 and 9.7%
Patient about to start insulin pump therapy at the CHU Sainte-Justine
Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine
3 exclusion criteria prevent from participating
Home of the patient at more than 50km of the CHU Sainte-Justine
Refusal to consent
Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin < 0.5U/kg/day
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center