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Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

NCT ID: NCT01016457

Last Updated: 2009-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Keywords

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Guardian RT

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.

Intervention Type DEVICE

Other Intervention Names

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Real-time continuous glucose monitoring

Eligibility Criteria

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Inclusion Criteria

* Duration of diabetes for more than 6 months
* Use of insulin pump for more than 3 months
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ped Endocrine & Diabetes Unit, Safra's Children Hospital, Sheba Medical Center

Principal Investigators

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Kineret Mazor-Aronovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Kineret Mazor-Aronovitch, MD

Role: CONTACT

Phone: 972-3-5305022

Email: [email protected]

Orit Pinhas-Hamiel, MD

Role: CONTACT

Phone: 972-3-5305015

Email: [email protected]

Facility Contacts

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Kineret Mazor-Aronovitch

Role: primary

Other Identifiers

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SHEBA-07-4980-KMA-CTIL

Identifier Type: -

Identifier Source: org_study_id