DiaMonD Case Study

It is important for people with diabetes to control their blood sugar. Scientific studies have shown that good control of blood sugar delays the long-term complications of diabetes such as heart disease, kidney failure, amputations, skin ulcers (sores), and blindness. Today, most people with diabetes monitor their blood sugar by sticking their fingertips or forearms to get a sample of blood. They apply the blood onto test strips and use a glucose meter to read their blood sugar level.

Purpose of the study

The purpose of this study is to examine the potential value of adding CGM (Continuous Glucose Monitoring) and possibly an insulin pump for persons with diabetes who use multiple daily insulin injections (MDI) and who rely on finger sticks alone to manage their blood sugar values.

This study will also look at potential health-economic, and quality of life benefits which may be gained during the study. These potential benefits will be examined through the use of questionnaires which you may be asked to complete at up to 3 different visits. The CGM system will be worn for home use, as per FDA-approved intended use. For the entire duration of the study you will be expected to use blood sugar measurements from the provided meter(s) to make decisions about adjusting your daily insulin therapy. You will not make treatment decisions using the readings from the CGM system. Any meter provided to you for the study will be FDA cleared and available for sale.

Participants will:

1. Be diagnosed with Type 1 or insulin-requiring Type 2 Diabetes
2. Be using finger sticks to monitor blood glucose 3 or more times a day

Study Information:

1. The study will provide study-related visits, study medication, CGM, blood glucose meter and supplies free of charge.
2. Phase 1 of the study will last about 6 months with up to 6 visits. Eligible subjects with Tl DM will continue to Phase 2 which will last about 6 months with up to 4 visits.
3. Participants must have a stable local A 1 C of: 7.7% to 10%.
4. Participants will receive CGM, glucose meter, and diabetes management training, physical exams, and lab tests (blood).
5. Parking is free. Patients will receive up to $465 for travel and inconvenience if all visits are completed.

Primary Outcome Measurement:

This study measures whether the addition of real time continuous glucose monitoring improves glycemic outcome in patients using multiple daily injections and self-monitored blood glucose who are not at their target A 1 C.

I’M INTERESTED! WHO DO I CONTACT FOR MORE INFORMATION?

Contact Information: Granger Medical Clinic, Research Department

Study Coordinator(s) Name: Kim Martin or Carrie Briscoe

Phone Number: 801.302.1769 or 801.302.1721

Investigator(s): Michelle Litchman, PhD, FNP-BC