CClinicalTrials.gg
Status unknownNCT01840358Updated Apr 26, 2013

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

An interventional study of Observation of hypoglycemias frequency 3 days before and after pump initiation in Type 1 Diabetes, sponsored by St. Justine's Hospital. Status unknown at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2013-04-26.

Sponsored by St. Justine's Hospital · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Hypoglycemias
  • Insulin pump
  • Children
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

St. Justine's Hospital is the lead sponsor of 155 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Patients starting pump therapy

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

Interventions

  • OtherObservation of hypoglycemias frequency 3 days before and after pump initiation
06

What researchers measure

Primary outcomes

  1. Frequency of hypoglycemias

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

    Time frame: 6 days

Secondary outcomes

  1. Frequency of hyperglycemias

    Frequency of hyperglycemias defined as blood sugars \> 17.0mmol/L

    Time frame: 6 days

07

Study locations

1 of 1 sites recruiting
  • CHU Sainte-Justine
    Montreal, Quebec H3T 1C5, Canada
    Recruiting
08

References and documents

Publications

  • 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. PubMed 28484424 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01840358
Lead sponsor
St. Justine's Hospital
Responsible party
Patricia Olivier (Pediatric endocrinologist, St. Justine's Hospital) — Principal investigator
First posted
Apr 25, 2013
Start date
Apr 2013
Primary completion
Dec 2013 (estimated)
Last update
Apr 26, 2013

Study contacts

Patricia Olivier, MD
Contact
patricia.olivier.hsj@ssss.gouv.qc.ca
514-345-4931 ext. 5486
patricia Olivier, Md
principal investigator · St. Justine's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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