Dexcom Wants to Take its CGM Technology to the Hospital Setting
The San Diego, CA-based company won breakthrough device designation for its CGMs to be used in the hospital setting.
March 3, 2022
Dexcom wants to bring its continuous glucose monitoring technology to the hospital setting. For years, the San Diego, CA-based company’s CGMs have held strong a presence in patients’ consumers’ homes with commercials for the technology airing during the SuperBowl.
Now – thanks in part to a breakthrough device designation from FDA, Dexcom gearing up to bring the innovation to the hospital and challenge the fingerstick – traditional method of checking glucose levels in the hospital.
Dexcom’s CGM’s were tested in the hospital setting at the Scripps Whittier Diabetes Institute in San Diego. The use of the CGM was able to help clinicians get a better handle on the limitations of fingerstick, said Athena Philis-Tsimikas, MD, endocrinologist and corporate vice president for the Scripps Whittier Diabetes Institute.
One of the difficulties with the finger stick is the timing of it, which can be totally unrelated to what’s going on with the patient’s eating and insulin dosage, she said.
“That’s probably the biggest difficulty,” Philis-Tsimikas told MD+DI. “You want to give certain kinds of insulin in the hospital right before someone eats or right after someone eats, so you can time it with the food."
She added, that there are many variables, such as when will the patient receive their food, which might make it difficult to get the blood/sugar value at the right time.
“If you had this CGM you could just swipe and look at the number to determine if the patient just ate,” she said. "You could calculate the patient’s dose of insulin and give them the right amount of insulin at the right time.”
Results from a 110-patient study with a CGM device recorded an average glucose level of 220 mg/dL, compared with 238 mg/dL among patients receiving standard care. The amount of time spent in hyperglycemia (with a blood sugar reading greater than 250 mg/dL) was 11% lower in the CGM group than it was in the standard care group.
Study results also showed the CGM device did not interrupt patients as they slept or cause them any discomfort. Other issues, such as persistent sensor signal loss and sensor detachment, were extremely rare.
But there are some issues that need to be ironed out before CGMs can be comfortably put into the hospital setting.
“We’re talking about the technology transmitting from the sensor to the transmitter; to the phone; then up to the cloud, and back at times to other people and providers,” Philis-Tsimikas said. “We saw this in the ambulatory environment. Getting setup in the hospital environment can be a little bit complicated.”
She added, “We had to think about that in a space where the nurses have no clue what this is, the physicians had no clue what this is, and most patients that we were putting this on had no clue what this was. The most complicated part, in the beginning, was to get all of those connections working.”
However, Philis-Tsimikas said the breakthrough device designation could help Dexcom smooth over the bumps.
Dexcom Has Big Plans
Dexcom is on the verge of some huge milestones. Most importantly, the company is waiting on FDA approval of its G7 sensor.
The company submitted to FDA for approval of G7 in 4Q21.
With respect to the CE mark filing for G7, the company said it expected that to come through in the quarter as well, but the new medical device regulation process in Europe has taken longer than expected.
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