Diabetes Mellitus
Conditions
Brief summary
This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.
Detailed description
Approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.
Interventions
DEVICESMBG
Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months.
Sponsors
Abbott Diabetes Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be 4 - 17 years of age. * Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment. * Subject is currently using SMBG for managing their diabetes. * Subject and/or caregiver must be able to read and understand English. * In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. * Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.
Exclusion criteria
* Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months. * Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. * Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment. * Subject is on dialysis at the time of enrollment. * Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. * Subject currently is participating in another clinical trial. * Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the SMBG devices. The safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in a pediatric patient population will be characterized: Serious Adverse events | six months | Rate of Serious Adverse events associated with Hypoglycemia and Hyper glycaemia will be determined. (e.g severe hypoglycemic occurrences requiring health care professional (HCP) intervention including EMT assistance, hospital/clinic visit and/or hospitalization and moderate hypoglycemia in which the patient required the assistance of another person \[e.g. as a result of confusion, coma, or seizure\] during the study. |
Countries
United States
Outcome results
None listed