Summary:
If you have type 2 diabetes mellitus that is uncontrolled with basal insulin, you may want to learn more about the BOLUS clinical research study.
What is the purpose of the BOLUS study?
The BOLUS study is being done to compare the FINESSE™ Insulin Delivery System to a standard pen for rapid-acting insulin delivery at mealtimes
What are the devices used in this study?
There are 3 devices used in this study: 2 rapid-acting mealtime insulin devices that are being compared to each other and 1 long-acting basal insulin device that will be used by all study participants. The FINESSE™ Insulin Delivery System is a discreet, wearable approach to rapid-acting insulin delivery that does not require mealtime injections. It is cleared for use in the United States and Europe for adults with diabetes mellitus.
Who can participate?
You may be able to join the study if you:
- Are 22 to 75 years old
- Have type 2 diabetes mellitus
- Have been treated with long-acting basal insulin for at least 6 months
There are other eligibility criteria that you must meet to participate. The study staff can discuss these criteria with you in greater detail.
What will I be asked to do?
If you are eligible and agree to participate in study, you will be required to visit the study clinic for study-related tests and procedures 9 to 12 times over the 1-year study period. Participants will be asked to use the study devices as instructed by the study doctor. You will also be asked to complete a food and blood glucose diary.
What are the potential risks and benefits?
Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.
Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have.