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Clinical Trial NCT01016457 for Diabetes Mellitus is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Sheba Medical CenterReal-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus Phase 4 15
Clinical Trial NCT01016457 is designed to study Diagnostic for Diabetes Mellitus. It is a Phase 4 interventional study that is unknown status, having started on 1 December 2008, with plans to enroll 15 participants. Led by Sheba Medical Center, it is expected to complete by 1 December 2009. The latest data from ClinicalTrials.gov was last updated on 19 November 2009.
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 consequenc...Show More
Official Title
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
Conditions
Diabetes MellitusOther Study IDs
- SHEBA-07-4980-KMA-CTIL
NCT ID Number
Start Date (Actual)
2008-12
Last Update Posted
2009-11-19
Completion Date (Estimated)
2009-12
Enrollment (Estimated)
15
Study Type
Interventional
PHASE
Phase 4
Status
Unknown status
Keywords
Diabetes Mellitus
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
HbA1C | Start of study, after 3 months, after 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Eligibility Criteria
Eligible Ages
Child
Minimum Age
1 Year
Eligible Sexes
All
- Duration of diabetes for more than 6 months
- Use of insulin pump for more than 3 months
Sheba Medical Center74 active studies to exploreStudy Central Contact
Contact: Kineret Mazor-Aronovitch, MD, 972-3-5305022, [email protected]
Contact: Orit Pinhas-Hamiel, MD, 972-3-5305015, [email protected]
1 Study Locations in 1 Countries
Sheba Medical Center, Ramat Gan, Israel
Kineret Mazor-Aronovitch, Contact, [email protected]
Recruiting