A more convenient blood glucose monitoring system integrated with a responsive mobile health app may facilitate improved diabetes control in adolescent and young adult patients with Type 1 diabetes. The primary aim of this study is to determine if the POPS diabetes management system can improve diabetes control in the adolescent and young adult population. The investigators hypothesize that use of the POPS diabetes management device and mobile application (app) will be associated with lower HbA1C after 6-months of use in adolescent and young adult T1D patients.
This is a prospective, single-arm, single-subject clinical trial to study outcomes related to device use in the pediatric diabetes population. Patients will be recruited at the Children's Minnesota McNeely Diabetes Clinic and satellite clinics during routine office visits over a 6-month period until recruitment goals are met. Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months with periodic check-ins and follow-ups. Primary outcome, HbA1c, will be measured at baseline and 6-month follow-up. Secondary aims include assessment of blood glucose testing frequency and quality of life scores following 6-months of device and app use. The investigators will also describe sustained use over the study period, average blood glucose and variability, and frequency of hypoglycemic events (blood glucose \<70). Historical data for each patient will also be recorded from medical records, with each patient serving as their own comparative control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months. Primary outcomes will be measured at baseline and 6-month follow-up.
Children's Hospitals and Clinics of Minnesota
Saint Paul, Minnesota, United States
RECRUITINGHbA1c
Change in HbA1c from baseline to 6 months
Time frame: 6 months
Testing frequency
Blood glucose testing frequency
Time frame: 30 days prior to enrollment to 6 months post-enrollment
quality of life
Peds QL diabetes module
Time frame: 30 days prior to enrollment to 6 months post-enrollment
Average blood glucose
Average blood glucose during 30 days prior to enrollment and during the 6 month intervention
Time frame: 30 days prior to enrollment to 6 months post-enrollment
Blood glucose variability
Blood glucose variability during 30 during prior to enrollment and during the 6 months of intervention
Time frame: 30 days prior to enrollment to 6 months post-enrollment
Hypoglycemia
Frequency of hypoglycemic events during intervention
Time frame: 6 months
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