NCT01016457

Brief Summary

The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_4 diabetes-mellitus

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

December 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 19, 2009

Status Verified

November 1, 2009

Enrollment Period

8 months

First QC Date

November 18, 2009

Last Update Submit

November 18, 2009

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    Start of study, after 3 months, after 6 months

Secondary Outcomes (3)

  • Quality of life

    Before and after connecting to sensor

  • Number of night hypoglycemias

    During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting

  • Mean glucose level

    During the first week of connecting to sensor and during the last week of connecting

Interventions

Guardian RTDEVICE

The sensor is inserted similarly to the insulin pump. It measures sub cutaneous glucose every 5 minutes. It alerts of high and low glucose levels, according to set limits.

Also known as: Real-time continuous glucose monitoring

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Duration of diabetes for more than 6 months
  • Use of insulin pump for more than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kineret Mazor-Aronovitch, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kineret Mazor-Aronovitch, MD

CONTACT

972-3-5305022kineret@gmail.com

Orit Pinhas-Hamiel, MD

CONTACT

972-3-5305015Orit.Hamiel@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

November 19, 2009

Record last verified: 2009-11

Locations

IL(1)