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Trial record 3 of 873 for:    hypoglycemia | "Diabetes Mellitus, Insulin-Dependent"

Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01840358
Recruitment Status : Unknown
Verified April 2013 by Patricia Olivier, St. Justine's Hospital.
Recruitment status was:  Recruiting
First Posted : April 25, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Patricia Olivier, St. Justine's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Observation of hypoglycemias frequency 3 days before and after pump initiation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes
Study Start Date : April 2013
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Patients starting pump therapy Other: Observation of hypoglycemias frequency 3 days before and after pump initiation



Primary Outcome Measures :
  1. Frequency of hypoglycemias [ Time Frame: 6 days ]
    Frequency of hypoglycemias defined as blood sugars < 4.0mmol/l


Secondary Outcome Measures :
  1. Frequency of hyperglycemias [ Time Frame: 6 days ]
    Frequency of hyperglycemias defined as blood sugars > 17.0mmol/L



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine
  • Patient about to start insulin pump therapy at the CHU Sainte-Justine
  • Last HbA1c between 7.2 and 9.7%
  • Informed and signed consent

Exclusion Criteria:

  • Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin < 0.5U/kg/day
  • Home of the patient at more than 50km of the CHU Sainte-Justine
  • Refusal to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840358


Contacts
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Contact: Patricia Olivier, MD 514-345-4931 ext 5486 patricia.olivier.hsj@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CHU Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Patricia Olivier, MD    514-345-4931 ext 5486    patricia.olivier.hsj@ssss.gouv.qc.ca   
Principal Investigator: Patricia Olivier, MD         
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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Principal Investigator: patricia Olivier, Md St. Justine's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patricia Olivier, Pediatric endocrinologist, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01840358     History of Changes
Other Study ID Numbers: HSJ-3638
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Patricia Olivier, St. Justine's Hospital:
Hypoglycemias
Insulin pump
Children

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases