NCT01840358

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

April 22, 2013

Last Update Submit

April 25, 2013

Conditions

Type 1 Diabetes

Keywords

HypoglycemiasInsulin pumpChildren

Outcome Measures

Primary Outcomes (1)

  • Frequency of hypoglycemias

    Frequency of hypoglycemias defined as blood sugars \< 4.0mmol/l

    6 days

Secondary Outcomes (1)

  • Frequency of hyperglycemias

    6 days

Study Arms (1)

Patients starting pump therapy

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

Interventions

Observation of hypoglycemias frequency 3 days before and after pump initiationOTHER
Patients starting pump therapy

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28484424DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Lead

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • patricia Olivier, Md

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Olivier, MD

CONTACT

514-345-4931patricia.olivier.hsj@ssss.gouv.qc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric endocrinologist

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 25, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations

CA(1)