Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus
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.
Interventions
DEVICEGuardian 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.
Sponsors
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Duration of diabetes for more than 6 months * Use of insulin pump for more than 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1C | Start of study, after 3 months, after 6 months |
Secondary
| Measure | 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 |
Countries
Israel
Contacts
Primary ContactKineret Mazor-Aronovitch, MD
Backup ContactOrit Pinhas-Hamiel, MD
Outcome results
None listed