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NCT01840358 Clinical Trial

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

Type 1 Diabetes Clinical Trial

Official title:
Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01840358
Other study ID # HSJ-3638
Secondary ID
Status Recruiting
Phase N/A
First received April 22, 2013
Last updated April 25, 2013
Start date April 2013

Study information
Verified date April 2013
Source St. Justine's Hospital
Contact Patricia Olivier, MD
Phone 514-345-4931
Email patricia.olivier.hsj@ssss.gouv.qc.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• Observation of hypoglycemias frequency 3 days before and after pump initiation

Locations
Country Name City State
Canada CHU Sainte-Justine Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of hypoglycemias Frequency of hypoglycemias defined as blood sugars < 4.0mmol/l 6 days No
Secondary Frequency of hyperglycemias Frequency of hyperglycemias defined as blood sugars > 17.0mmol/L 6 days No
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