Is CGM Beneficial for Those on Injections?
By Kelly Close
Welcome to trial watch, where we keep an eye on the latest and greatest trials going on in the field of diabetes. Here, you can learn about new therapies and devices currently under study, and learn more about participating in these trials. Trial participants can get early access to new treatments, receive care at clinical trial centers, and are usually compensated for their time. You can read more about clinical trials at the “Center Watch” volunteer page or the ClinicalTrials.Gov information page.
Clinical Trial Identifier: NCT02282397
Trial name: Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD)
Diabetes type: Type 1 diabetes and type 2 diabetes.
What it’s testing: The trial is examining if the addition of continuous glucose monitoring (CGM) to patients on multiple daily injections (MDI) can help improve glycemic control. The trial has two phases: in the first phase, MDI patients will be randomized to either usual care (fingersticks alone) or the use of CGM. In phase 2, all users will move to CGM and be further randomized to either add an Insulet OmniPod insulin pump or stay on MDI.
What the trial is measuring: The trial will measure participants’ A1c change at six months and one year, as well as changes in quality of life and cost-effectiveness.
Why this is new/important: Previous research has primarily focused on the addition of CGM to people on pumps. This large study will bring new data on the value of CGM in people on injections, the majority of people with type 1 and type 2 diabetes. The two-phase design will also show what incremental benefit an insulin pump adds over CGM alone. Last, the 12-month trial will measure healthcare costs, providing critical data on what these technologies truly cost the system (e.g., Can reduced hospitalizations offset the devices' cost?).
Trial Length: One year.
Trial Location: The trial has 17 sites that are currently recruiting, located in CA, FL, GA, ID, MI, MN, MO, OR, and TX.
Do you qualify? To qualify for this study, participants must be 25 years or older, have type 1 or type 2 diabetes, have an A1c > 7.5%, be using multiple daily injections and regularly performing blood glucose monitoring, and be willing to wear CGM and potentially use an insulin pump (for people with type 1 diabetes only) during the study. Exclusion criteria include a recent hospitalization or emergency room visit in the six months prior to screening, having moderate or severe renal disease, or having other conditions that impact the A1c measurement or the ability to participate in the study.
Where to get more information: To get more information about this trial’s details and how to participate, please see the clinicaltrials.gov page. -AJW/AB
