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

Primary Purpose

Diabetes Mellitus

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Guardian RT

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus focused on measuring Diabetes Mellitus

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Sheba Medical CenterRecruiting

Outcomes

Primary Outcome Measures

HbA1C

Secondary Outcome Measures

Quality of life

Number of night hypoglycemias

Mean glucose level

Full Information

NCT ID

NCT01016457

First Posted

November 18, 2009

Last Updated

November 18, 2009

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01016457

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2008 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus

Keywords

Diabetes Mellitus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Guardian RT

Other Intervention Name(s)

Real-time continuous glucose monitoring

Intervention Description

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.

Primary Outcome Measure Information:

Title

HbA1C

Time Frame

Start of study, after 3 months, after 6 months

Secondary Outcome Measure Information:

Title

Quality of life

Time Frame

Before and after connecting to sensor

Title

Number of night hypoglycemias

Time Frame

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

Title

Mean glucose level

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Duration of diabetes for more than 6 months Use of insulin pump for more than 3 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kineret Mazor-Aronovitch, MD

Phone

972-3-5305022

kineret@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Orit Pinhas-Hamiel, MD

Phone

972-3-5305015

Orit.Hamiel@sheba.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kineret Mazor-Aronovitch, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Ramat Gan

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kineret Mazor-Aronovitch

kineret@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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