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

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Other: Observation of hypoglycemias frequency 3 days before and after pump initiation

• Registration Number: NCT01840358
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-25
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients starting pump therapy	Observation of hypoglycemias frequency 3 days before and after pump initiation	-

Primary Outcome Measures

Name	Time	Method
Frequency of hypoglycemias	6 days	Frequency of hypoglycemias defined as blood sugars \< 4.0mmol/l

Secondary Outcome Measures

Name	Time	Method
Frequency of hyperglycemias	6 days	Frequency of hyperglycemias defined as blood sugars \> 17.0mmol/L

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada