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New STAR 3 Data Released at ADA

By Amanda Sheldon

Managing Editor

Posted:  7/26/2011 12:00 AM

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At this year’s American Diabetes Association Scientific Sessions, new clinical data was released from the landmark STAR 3 Study which compared A1C reduction for people using an insulin pump integrated with CGM to those using multiple daily injections (MDI). We are excited to share this new data with you and hope it motivates you to keep up your good work managing diabetes. Since this 18-month study produced a lot of data, we have developed an infographic to highlight some of the key results.

First published in the New England Journal of Medicine in June 2010, the STAR 3 study showed that Medtronic’s integrated system (insulin pump integrated with CGM) provides adults, children and teens with better glucose control compared to multiple daily injections (MDI). The 244 people using an insulin pump integrated with CGM had a reduction in mean A1C levels that was four times greater than the 241 people using MDI (from a baseline of 8.3 percent to 7.5 percent in the sensor-augmented pump therapy group, compared to only 8.3 percent to 8.1 percent in the MDI group (p<.001)).

After 12 months of the study, those who had been using MDI had the opportunity to switch to insulin pump therapy integrated with CGM. The18-month data just released at ADA showed that those people who switched at the 12-month mark had a mean A1C reduction from 8.1 to 7.6. after six months on insulin pump therapy integrated with CGM.

After the JDRF CGM studies, one of the lead investigators, Dr. Bruce Bode, remarked that one has to use a CGM sensor to see a benefit from it. Makes sense, right? Well, once again this was shown to be true. In both phases of the study, the more often people used the sensor with the insulin pump, the more effectively they managed their disease. In fact, adults who used the sensor more than 81% of the time, had a mean A1C drop of 1.2%.

Decoding Study Language
All sounds good, right? Or perhaps you may be asking yourself, what does mean A1C mean? Well, in a large-scale study such as STAR 3, there are a lot of participants – in this case a total of 485 and 244 and 241 in each of the two arms. Results of all participants are averaged to get the mean result.

Two arms? A randomized, controlled study such as STAR 3 will contain 2 (or more) groups for comparison called “arms of the study.”  One group, called the control group, uses a known treatment, usually the standard of care – in this case, MDI. The second group, the study group, uses the advanced technology (or drug in pharmaceutical studies) being investigated. The results of the two groups are then compared, to evaluate how the technology being investigated did at treating the condition being studied. Participants in the study are randomly assigned to the control or study group.

STAR 3 included a cross-over phase. This means that after the first year of the study, participants in the control group – the MDI group – had the opportunity to “cross-over” and try insulin pump therapy integrated with CGM for six months. The original study group (who were already on insulin pump therapy integrated with CGM) stayed on their same therapy for another six months. The cross-over phase is important because it provides a comparison for how the same group of people did on the two types of therapy. In this case, they did better using Medtronic’s integrated system.

For the original study group on insulin pump therapy integrated with CGM, we were able to capture 18-months worth of data. For this group, the study showed that their A1C dropped within the first 3 months and was maintained for the entire 18 month study. Long-term data is good, because it provides additional evidence that therapy works.

And for all of you trivia buffs out there, why was it called STAR 3? Many studies have a short-hand name that is composed by taking initial letters out of a phrase that describes the study. The clinical term for an insulin pump integrated with CGM is sensor-augmented pump. The study name is: The Sensor-Augmented Pump Therapy for A1C  Reduction. The 3 comes from the fact that this is the third in a series of trials that Medtronic has conducted on sensor-augmented pump therapy.

We’d like to hear from you if these explanations are helpful, and what you think of the infographic, so let us know through the comments!

IMPORTANT SAFETY INFORMATION
- Medtronic Diabetes insulin infusion pumps, continuous glucose monitoring systems and associated components are limited to sale by or on the order of a physician and should only be used under the direction of a healthcare professional familiar with the risks associated with the use of these systems.
- Successful operation of the insulin infusion pumps and/or continuous glucose monitoring systems requires adequate vision and hearing to recognize alerts and alarms.

Medtronic Diabetes Insulin Infusion Pumps

- Insulin pump therapy is not recommended for individuals who are unable or unwilling to perform a minimum of four blood glucose tests per day.
- Insulin pumps use rapid-acting insulin. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin immediately.

Medtronic Diabetes Continuous Glucose Monitoring (CGM) Systems

- The information provided by CGM systems is intended to supplement, not replace, blood glucose information obtained using a home glucose meter. A confirmatory fingerstick is required prior to treatment.
- Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected.

Please visit www.medtronicdiabetes.com/about/safety.html for complete safety information.

Comments

Karol

Posted on Tue Aug 09 04:32:12 GMT 2011

I'm a pump and CGM believer and wearer and also anRN CDE. One of many questions I get almost daily is " when is the patch pump coming out?" What's the hold-up??

Amanda

Posted on Thu Aug 11 15:21:00 GMT 2011

@Karol Nice to hear from you and thanks for all the work you do - big cheers for CDEs! :-) Regarding your question, unfortunately I don't have timelines for future products. However, I can tell you that patch technology is one of several technologies in our pipeline that we'd love to bring to market. And I can tell you we're also spending quite a lot of time and effort right now on bringing to the US products that are already approved in other countries. I'm sorry that's pretty vague. But, unfortunately, it's all I have right now.

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