Recruiting

Observational Study

Sponsor:

St. Justine's Hospital

Code:

NCT01840358

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Observation of hypoglycemias frequency 3 days before and after pump initiation

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT01840358

Start date

Apr, 2013

Status verified date

Apr, 2013

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Interventions and Outcome Measures

Arms

other: Patients starting pump therapy

Interventions

Observation of hypoglycemias frequency 3 days before and after pump initiation

Primary outcome measure

  • Frequency of hypoglycemias [ Time Frame: 6 days ]

Central Contacts and Locations

Central contacts

Locations

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Principal Investigator:

Patricia Olivier, MD

More Information

Sponsor

St. Justine's Hospital

Last update posted

Apr 26, 2013

Last verified

Apr, 2013

Keywords

  • Hypoglycemias
  • Insulin pump
  • Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2013-04-26.