E14
Conditions
Interventions
Group 1: Study population:
83 children and adolescents with diabetes mellitus divided in three different age groups.
Group 1 (children – age 2-6 years): 25 subjects
Group 2 (children – age 7-13 years)
Sponsors
i-SENS, Inc.
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: • Clinical diagnosis of diabetes mellitus for at least 3 months • Subjects with intensified insulin therapy (MDI or CSII) for at least 3 months • Subject agrees to participate in the study by giving informed consent/assent (as applicable) • Parent(s)/guardian(s) has/have signed an informed consent form and is/are willing to comply with protocol requirements
Exclusion criteria
Exclusion criteria: • Subjects with severe hypoglycemia events within 3 months prior to screening. Severe hypoglycemia is defined as loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia • Hypoglycemia unawareness • Subjects with diabetic ketoacidosis within 3 months prior to screening • Subjects with abnormal skin/skin diseases at the CGM sensor attachment site • Subjects with allergic contact dermatitis to medical adhesives • Diagnosed with any chronic medical, psychiatric, developmental / behavioral condition that at the discretion of the investigator would affect their performance in the study. • Subjects scheduled for unchangeable X-ray, MRI, or CT during the study • Patients unwilling to abstain from use of nutritional supplements containing xylose • Female subjects with sexual maturity: pregnancy, lactation period, lack of a negative pregnancy test • Dependency from the sponsor or the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %20/20 agreement rate, defined as the percentage of CS Air-comparator pairs with deviations =±20 mg/dl or =±20 % for: ? Pooled data from subjects in age groups 2 and 3 ? Data from arm sensors in age group 1 ? Data from buttock sensors in age group 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Agreement between CGM and comparator values (%15/15, %20/20, %30/30, %40/40 and >%40/40 agreement rates) ? Mean differences between capillary comparator values and CGM values (absolute relative difference [MARD], relative difference [MRD], absolute difference [MAD], difference [MD]) ? Sensor precision, calculated as mean paired relative absolute difference (PARD) between CGM values sensors worn by the same subject on the same insertion site ? Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA) ? Consensus error grid analysis ? Trend accuracy using rate error grid analysis ? Sensor stability ? Alert reliability ? Technical reliability (sensor survival, data availability, device deficiencies) ? Precision ? User satisfaction | — |
Countries
Germany
Contacts
Public ContactManuela Link
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed