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Study Objective & Methods

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Presentation on theme: "Study Objective & Methods"— Presentation transcript:

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2 Study Objective & Methods
Dexcom G6 has the same alerts and alarms as G5 with the addition of the Urgent Low Soon Alert. Study Objective & Methods Objective: Evaluate the impact on time spent in hypoglycemia in CGM and FGM users with impaired awareness of hypoglycemia (IAH). Research Design/Methods: • Randomized, controlled trial; 8-week treatment period • Adults with type 1 diabetes on multiple daily injections of insulin (n=39); split into CGM use (n=19) or FGM use (n=20) • Gold score† 4 (impaired hypo awareness or recent severe hypoglycemic event) † The Gold score measures hypoglycemia awareness, based on a response to, “Do you know when your hypos are beginning”;7-point scale, with 1 representing “always aware” and 7 “never aware”. Scores ≥4 indicate IAH.

3 Dexcom CGM users reduced time spent in hypoglycemia, while Libre FGM users increased their exposure to hypoglycemia. Dexcom CGM users decreased time in hypoglycemia at night, while Libre FGM users experienced worsening hypoglycemia. Dexcom CGM users saw a significant reduction in hypoglycemia fear compared to Libre FGM users.

4 While there are a variety of alerts, there’s just one alarm: the Urgent Low Alarm (alarm) at 55 mg/dL. The alarm can’t be changed or turned off with one exception. An Android phone, that has turned on Total Silence or No Exceptions, if this is turned on the user won’t get any alerts, including the Urgent Low.

5 The Urgent Low Soon Alert notifies when the user will be 55 mg/dL in less than 20 minutes. This alert can be turned off in settings. Depending on how quickly the user will be at 55 mg/dL, you either get their Urgent Low Soon Alert or their Low Alert: Within 20 minutes = Urgent Low Soon Alert Not that fast = Low Alert

6 The threshold alert is set at 80mg/dL
The threshold alert is set at 80mg/dL. If a user is dropping quickly the 80 alert would not have sounded until the user was ~60mg/dL (not giving them enough time to avoid a serious hypoglycemic event). With the Urgent low soon alert ”on” then the user is provided an advanced warning and can proactively treat to avoid a severe low. If ULS is ‘on’ then the tradeoff is the user will not get the threshold alert (to avoid nuisance)

7 The Low Alert notifies when G6 readings are below the target glucose range.
The High Alert notifies when G6 readings are above the target glucose range. During initial set up, patients will be prompted to establish low and high alert levels. Alerts can be customized or turned off in settings. The user chooses the sound they want the alert to make.

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9 Jane’s parents picked her up from school and immediately gave her a juice box. She was wandering around, completely spacey. She was at 65 mg/dL and falling. She got her low alert at 70 but didn’t do anything. What happened?

10 Jane’s parents brought up her lows with her endocrinologist
Jane’s parents brought up her lows with her endocrinologist. He showed them how to use the Low Alert to get Jane’s attention while she can still think clearly enough to act and eat something to avoid a low. Based on his recommendation, we raised it to 80 mg/dL and rubber banded PEZ® to her iPhone. We also made sure her Urgent Low Soon Alert was on. Mom also set her Share Low Alert to 85. Jane promised to text her mom a picture of a candy emoji when she treated. It’s worked! This week, she has acted on her Low Alerts and hasn’t gone below 70 mg/dL!

11 Mike’s HCP noticed in the CLARITY downloads his high alert was turned off.
Mike’s HCP asked him why his high alert was turned off. He said his high alert was going off all the time and it was making him crazy.

12 Mike’s HCP realized Mike had accepted the default high alert of 200 when setting up his G6 app. When Mike started CGM 3 months ago his A1C was 9. They set the high alert higher… at a level where he would need to do something. It worked! Mike don’t get High alerts all the time, and when he does he knows he probably needs to act.

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16 Always sound feature not available on the Dexcom receiver
Always sound feature not available on the Dexcom receiver. If always sound is on, alerts will sound even when silent or do not disturb is on. If Always Sound is off alerts will default to phone setting, so if the user’s phone is on vibrate their alerts will vibrate, if their phone is on silent their alerts will be silent. Urgent Low, Transmitter Failure, and Sensor Failure can’t be silenced.

17 Alert schedule feature not available on the Dexcom receiver
Alert schedule feature not available on the Dexcom receiver. Schedule and customize a second group of alerts. For example, set different alert settings for night.

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