Dr. Francine Kaufman Discusses Results of STAR 3 Trial

Last week, the ADA simultaneously with the New England Journal of Medicine announced the results of the STAR 3 trial (Sensor-Augmented Pump Therapy for A1C Reduction).

Bottom line: Using a pump combined with a CGM resulted in significantly better blood glucose control as compared to MDI alone.

Thanks to Manny, I had the opportunity to talk with Dr. Francine Kaufman, Vice President of Global Medical Affairs, Medtronic Diabetes, about the trial.

Medtronic sponsored the study and the candidates chosen for sensor-augmented pump therapy used the Medtronic MiniMed Paradigm® REAL-Time System. This system provides sensor-augmented pump therapy through three elements: the MiniMed Paradigm® insulin pump, CGM and CareLink® therapy management software.

Here are the particulars of the trial:
1) There were 485 participants; 329 adult and 156 pediatric patients.
2) All participants were previously using MDI.
3) All participants were previously not achieving the goal A1C for their age group. Starting A1Cs ranged from 7.4-9.5.
4) The trial was conducted over a year, the longest study of its kind.
5) Participants on MDI were trained on the CareLink® therapy management software and had their results reviewed quarterly.
6) Participants on sensor-augmented pump therapy were trained on the software, pump and CGM and had their results reviewed quarterly.

Here are the results:
1) All age groups showed a marked improvement in mean A1C levels over a sustained period of time in the sensor-augmented pump therapy group. On an aggregate basis the improvement was a 0.8% decrease in mean A1C levels as compared to a 0.2% decrease in the MDI group.
2) Adults specifically achieved the best result of a full 1% improvement.
3) A six month extension period just ended, but those results are not yet available.

Since my son was diagnosed, there are two specific studies that I have paid particular attention to. The DCCT and the JDRF CGM Clinical Trial. I refreshed my memory on these two studies to fully appreciate how STAR 3 differs:

1) The DCCT study conducted from 1983 to 1993 demonstrated that intensive therapy, whether by insulin pump or multiple daily injections, resulted in improved blood glucose control thereby slowing the onset and progression of diabetes complications as compared to injection therapy of fewer injections a day (then considered standard therapy). However, those on intensive therapy showed an increased risk of hypoglycemia.
2) The JDRF study demonstrated an improvement in A1C levels of about 0.5% when either pump participants or MDI participants augmented their therapy with a CGM. The benefit was achieved without a significant increase to the risk of hypoglycemia.

The STAR 3 trial takes things a step further by combining the benefits of both pumping and CGM use and directly compares this therapy with MDI therapy. As Dr. Kaufman stated, the benefits of each device are additive. Although not specifically isolated in the study, Dr. Kaufman felt it was fair to conclude that of the 1% total improvement seen in adults, 0.5% could be attributed to pump use and 0.5% could be attributed to CGM use based upon what we know from other research done. The results of the pediatric group are also noteworthy as this is the first confirmation of superior glucose control through sensor-augmented insulin pump therapy for children and adolescents.

Some other things we talked about –
1) Sensor accuracy: Some of my contemporaries who have used the MiniMed CGM have expressed disappointment in its accuracy as compared to other CGM systems available today. Dr. Kaufman stated that data assessing CGM accuracy shows similar results for all CGM systems.
2) MiniMed’s future in the patch pump market: Dr.Kaufman said indeed MiniMed wants to provide a full menu of options including a patch pump, but there were no specifics available regarding MiniMed’s plans for such a device.
3) Future of MiniMed’s sensors: There are two sensors currently in the “works”. The NEX sensor, which will have six day labeling and provide improved accuracy is currently under review by the FDA. Dr. Kaufman referred to it as a “significant leap” in sensor advancement and hopes this will be approved within a year. The ENLITE sensor Dr. Kaufman referred to as a “game changer”. This sensor will be half the size of MiniMed’s current sensor and the comfort and accuracy of it will be far beyond anything currently available. The ENLITE has just started clinical trials. Even so, Dr. Kaufman hopes for its approval by the FDA in a year’s time.



Great interview and summation, Lorraine!

Lorraine,
Thanks for taking the time to chat with Dr. Kaufman and summarizing your conversation for all of us to be familiar with it.

thanks lorraine :slight_smile:

promising info …we may have to wait a bit longer , here in Canada.
Thanks Lorraine .

This study is of little use other than its’ commercial value to Medtronic without a control group of MDI users using sensor-guided therapy. I suspect that Medtronic did not choose this design due to the possibility that they may have found that the improvements in a1c were primarily due to sensor use rather than to pump use! What trouble they might have had then with pump sales!