Type 1 or Type 2 Diabetes
Conditions
Brief summary
This study is observational, designed to collect real world use and safety data for those using the Bigfoot Unity Diabetes Management System for 12 months. Participants will be those with a prescription to use the Bigfoot Unity System. Medical practices prescribing Bigfoot Unity and Sponsor representatives will provide information about the study to current users and individuals considering initiation of the Bigfoot Unity System. During the course of the study, participants will be asked to use the Bigfoot Unity System in accordance with the prescription provided by their healthcare professional (HCP).
Interventions
DEVICEBigfoot Unity Diabetes Management System
The Bigfoot Unity System is a wirelessly connected set of hardware and software that is intended for use by people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. Bigfoot Unity consists of the Abbott FreeStyle Libre 2 Sensor, two durable insulin pen caps (one each for specific rapid-acting and long-acting insulin pens) and an iOS-specific mobile App.
Sponsors
Jaeb Center for Health Research
Bigfoot Biomedical Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 1 or type 2 diabetes diagnosis 2. HCP-prescribed, registered Bigfoot Unity users who have used the Bigfoot Unity System 2 weeks or less 3. Age 12 years or older at time of electronic informed consent 4. Using both long-acting and rapid-acting insulins that are compatible for use with the Bigfoot Unity System 5. Using long-acting insulin no more than 1 time per day 6. Must have baseline HbA1c collected within 90 days prior to starting the Bigfoot Unity System 7. Able to read and understand English 8. Participant or legally authorized representative for minors has the capacity to provide electronic informed consent 9. Resident of the United States 10. Persons who are using a phone that is compatible with Bigfoot Unity and not shared with a family member or a caregiver
Exclusion criteria
1. Females who are pregnant or intending to become pregnant during participation in the study 2. Persons with implantable medical devices such as pacemakers 3. Persons on dialysis or other serious medical conditions that would impact the ability to use the device or manage their diabetes 4. Persons taking or expected to be taking \>500mg Vitamin C supplements on routine basis 5. Persons employed by the Sponsor or JCHR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HbA1c | 3 months | Glycated hemoglobin |
| Percent time Sensor in range of 70 mg/dL to 180 mg/dL, inclusive | 3 months | — |
| Glucose management indicator | 3 months | — |
| Percent time Sensor in hypoglycemia | 3 months | Will evaluate Sensor below 70 mg/dL and below 54 mg/dL |
| Percent time Sensor in hyperglycemia | 3 months | Will evaluate Sensor above 180 mg/dL and above 250 mg/dL |
| Change from baseline in Diabetes Distress Scale | 3 months | Measures emotional and behavioral challenges generated by diabetes and its management; scale is 1.0 to 6.0, higher scores are worse. |
| Change from baseline in Hypoglycemia Confidence Scale | 3 months | Measures the degree to which people with diabetes feel able, secure, and comfortable regarding their ability to stay safe from hypoglycemic-related problems; scale is 1.0 to 4.0, higher scores are worse. |
| Change from baseline in Insulin Delivery Satisfaction Survey | 3 months | Measures the effectiveness, burdensomeness and inconvenience of an insulin delivery system; scale is 1.0 to 5.0, higher scores are better. |
| System Usability Scale | 3 months | Measures the usability of a system; scale is 0 to 100, higher scores are better. |
Countries
United States
Outcome results
None listed