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| Name | Class |
|---|---|
| Pops! Diabetes Care | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pops! One personalized mobile platform | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change in HbA1c from baseline to 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Testing frequency | Blood glucose testing frequency | 30 days prior to enrollment to 6 months post-enrollment |
| quality of life | Peds QL diabetes module |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Gandrud, MD | Contact | 651-220-6624 | laura.gandrud@childrensmn.org | |
| Krista Mullen, BS | Contact | 507-581-6000 | krista.mullen@childrensmn.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospitals and Clinics of Minnesota | Recruiting | Saint Paul | Minnesota | 55102 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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prospective, single-arm, single-subject clinical trial
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| 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 | 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 | 30 days prior to enrollment to 6 months post-enrollment |
| Hypoglycemia | Frequency of hypoglycemic events during intervention | 6 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |