Summary:
People with Type 1 Diabetes trying to reach blood glucose targets are at an increased risk of hypoglycemia (low blood sugar). This can become serious if not treated promptly.
Maintaining stable blood glucose levels within the recommended range without hypoglycemia is a difficult goal to achieve and requires close monitoring of diet, awareness of activity levels, and frequent
adjustments of insulin.
The inTandem5 trial is evaluating an investigational oral product that is given by mouth and may improve your blood glucose levels without increasing your risk for hypoglycemia.
About the Study
This clinical research study is being conducted to evaluate the safety and potential effectiveness of an investigational oral product for Type 1 Diabetes. This product is taken by mouth inTandem with your current insulin regimen and may help manage your blood glucose levels without increasing your risk for hypoglycemia.
Who can participate in this
clinical study?
As with all clinical research studies, you must meet criteria determined by the study protocol. You may be eligible to participate in this study if you:
- Are 18 - 30 years old
- Have a confirmed diagnosis of Type 1 Diabetes Mellitus
- Have A1C levels 9% or higher
Note: These are not the only eligibility criteria for the inTandem5 trial, and certain other criteria may exclude you. Only a clinical research team member can determine if you meet all necessary criteria to participate.
If you choose to participate in the study, the following will be performed at Screening to determine if you are eligible:
- Medical history
- Complete physical exam
- Laboratory blood tests
Qualified participants will attend approximately 11 office visits and receive periodic follow-up phone calls over a 5 month period. You will also be required to keep a study diary throughout the duration of your study participation and will be required to wear a Continuous Glucose Monitoring device for up to 5 weeks. As a participating subject, you may be eligible to receive compensation for your time and effort in participating in this study.