The “Star 3 Study” is here:
They want to use this study for two reasons: First, it combines pumping versus MDI with CGMS, so the results are a quagmire of two different major therapeutic changes being made at the same time. But second, and even better for them, this study defines “glycemic control” as better/lower HbA1c.
Minimed is happy to do this study because it might get them a new indication: Pumping with R/T “improves control” for nearly anybody now on MDI. Right now, as you know from your prescription forms, you need hypo unawareness and/or extreme, sudden “dangerous” bG changes to qualify. (I remember those two, I don’t remember how many other checkboxes there were to “qualify” the pt. as an FDA-approved CGMS candidate.)
So Minimed hopes this study will allow them to sell lots more CGMS, without needing a history of dangerous bG occurences to qualify. They’re hearing “Ka-Ching, new indication!” But, for people who are already qualified as appropriate CGMS pts., this study is totally irrelevant. The study explicitly excludes everyone who “Has suffered two or more documented events of severe hypoglycemia without warning of impending low glucose levels, within the previous 12 months”. And study participants must be insulin infusion pump naїve.
If your situation already matches FDA-approved indications, “waiting for this study” is just more irrelevant BS. Even worse (for you), this study DEFINES “changes in glycemic control” as HbA1c. They excluded the people with Hypos, so of course they can use lower A1c as an appropriate stand-in for “better control”. But if you’re using CGMS to avoid frequent dangerous Hypos, the study is fundamentally irrelevant: Wrong inclusion/excusion criteria, Wrong method of measuring “results”, wrong everything. Totally inapplicable.
In a “Boston Legal” show last year, Denney Crane was talking with his son-- after winning the case against him, a case which his son SHOULD HAVE won easily. He said, “You lost the case when you let ME define the question.”
Same thing here-- if you let them define the question as “lower A1c”, then you almost certainly lose. CGMS doesn’t lower A1c in people who’s big pre-CGMS problem is frequent Hypos! That’s why they propose this study as “The Question”, and why you must take care to have “The Question” defined very differently.