NCT00361608

Brief Summary

This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
1.9 years until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 19, 2016

Status Verified

April 1, 2008

Enrollment Period

10 months

First QC Date

August 6, 2006

Last Update Submit

July 17, 2016

Conditions

Type I Diabetes

Keywords

diabeteshypoglycemiamonitorchildren with Type I Diabetes

Interventions

EarlySense ES 16DEVICE

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Diabetes I

You may qualify if:

  • Age between 12-18 years
  • Diagnosis of type I diabetes for at least a year
  • Home close to participating center
  • Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form.

You may not qualify if:

  • Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes.
  • Any other pre-existing medical pathology unrelated to diabetes.
  • Inability of the patient or his guardian to use the Guardian RT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Liat de Vries, M.D.

    Schneider Children's Medical Center, Israel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2006

First Posted

August 8, 2006

Study Start

July 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 19, 2016

Record last verified: 2008-04

Locations

IL(1)