Hypoglycemia at Initiation of Pump Therapy in Children Wi... | NCT01840358

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

NCT01840358

Sponsor

St. Justine's Hospital

Status

Unknown status

Last Update Posted

Apr 26, 2013Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

Observation of hypoglycemias frequency 3 days before and after pump initiation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Not provided

First Submitted Date

Apr 22, 2013

First Submission Date that Met QC Criteria

Apr 22, 2013

First Posted Date

Apr 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2013

Last Update Posted Date

Apr 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients starting pump therapy	Other		Other: Observation of hypoglycemias frequency 3 days before and after pump initiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation of hypoglycemias frequency 3 days before and after pump initiation	Other		Patients starting pump therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of hypoglycemias	Frequency of hypoglycemias defined as blood sugars < 4.0mmol/l	6 days

Secondary Outcomes

Measure	Description	Time Frame
Frequency of hyperglycemias	Frequency of hyperglycemias defined as blood sugars > 17.0mmol/L	6 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia Olivier, MD	Contact	514-345-4931	5486	patricia.olivier.hsj@ssss.gouv.qc.ca

Overall Officials

Name	Affiliation	Role
patricia Olivier, Md	St. Justine's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Sainte-Justine	Recruiting	Montreal	Quebec	H3T 1C5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28484424	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals