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

NCT ID: NCT01840358

Last Updated: 2013-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Patients starting pump therapy

Group Type OTHER

Observation of hypoglycemias frequency 3 days before and after pump initiation

Intervention Type OTHER

Interventions

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Observation of hypoglycemias frequency 3 days before and after pump initiation

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patricia Olivier

Pediatric endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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patricia Olivier, Md

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Patricia Olivier, MD

Role: CONTACT

514-345-4931 ext. 5486

Facility Contacts

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Patricia Olivier, MD

Role: primary

514-345-4931 ext. 5486

References

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Manousaki D, Deladoey J, Geoffroy L, Olivier P. Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation. Front Endocrinol (Lausanne). 2017 Apr 24;8:84. doi: 10.3389/fendo.2017.00084. eCollection 2017.

Reference Type DERIVED
PMID: 28484424 (View on PubMed)

Other Identifiers

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HSJ-3638

Identifier Type: -

Identifier Source: org_study_id

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