Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus
Phase 4
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT01016457
- Lead Sponsor
- Sheba Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Duration of diabetes for more than 6 months
- Use of insulin pump for more than 3 months
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method HbA1C Start of study, after 3 months, after 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Ramat Gan, Israel