Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Type 2 diabetes is a long-term illness that causes glucose, or blood sugar, levels to rise. People with type 2 diabetes need to monitor their glucose so they can adjust their diabetes treatment. For example, they may make changes to their medicine or their lifestyle. Doing so can help people stay healthy and avoid complications from diabetes.
People can monitor glucose in different ways. A blood test called hemoglobin A1c, or HbA1c, measures a person’s average glucose levels over the last three months. HbA1c is not helpful in managing diabetes on a daily basis, especially for people who take insulin.
One way to monitor glucose each day is with finger-stick blood glucose testing, where people draw a small amount of blood from their finger to test. For some people, finger sticks can hurt and be bothersome. Another way is using a continuous glucose monitor, or CGM. A CGM is a device that people wear that monitors their glucose at all times. Questions remain about how CGM and finger sticks compare in helping people manage type 2 diabetes daily.
In this study, the research team is comparing CGM and finger sticks for monitoring glucose levels among people with type 2 diabetes who use insulin.
Who can this research help?
Results may help people with type 2 diabetes who use insulin and primary care clinicians, such as doctors and nurses, when considering ways to monitor glucose levels.
What is the research team doing?
The research team is recruiting 354 adults with type 2 diabetes who are receiving care at one of 30 primary care clinics in Minnesota and Wisconsin. The team is assigning clinics by chance to have their patients use either CGM or finger sticks to monitor their glucose for one year. The team is training clinic staff to use either finger stick or CGM results to help people manage their diabetes. People taking part in the study are getting their diabetes care through their usual primary care team during the study.
The research team is measuring patients’ HbA1c at the start of the study and again 6 and 12 months later. The team is also surveying patients about:
- Stress related to diabetes
- How often they test their glucose
- How satisfied they are with their method for monitoring glucose
- How often they have fears about low glucose from taking insulin
- Quality of life
- Diet and exercise
People with diabetes, doctors, nurses, dietitians, health insurers, and representatives from advocacy and professional groups are helping to plan and conduct this study.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 354 adults ages 18–75 with type 2 diabetes and HbA1C of 7.5% to 12% who use insulin to manage their diabetes |
| Interventions/ Comparators |
|
| Outcomes |
Primary: HbA1C Secondary: diabetes distress, length of time when blood sugar is in normal range, hypoglycemia episode, frequency of on-demand blood glucose testing, devices’ impacts on diabetes self-care activities, satisfaction with glucose monitoring, fear of hypoglycemia, quality of life, diet and exercise, individual and organizational barriers and facilitators to use of glucose data at clinic visits |
| Timeframe | 1-year follow-up for study outcomes |
|
*Patient-Centered Economic Outcomes Funding Supplement |
Project Information
Key Dates
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.