Clinical FAQ Flashcards
What might you say to a provider who asks about off label patient profile? (ESRD, HD, PD)
The iLet was not tested with CKD or ESRD specifically, therefore avoid recommendations for this patient profile. Speak to iLet algorithms to allow HCP the opportunity to make decisions for their patient.
What might you say to a provider concerned about hypogycemia risk?
Risk of lows can be decreased in patients who are proactive in appropriately announcing carb containing meals/snacks as well as avoiding over treating lows.
What might you say to a provider who asks about surgery or hospital considerations?
No recommendations, refer to med affairs; however: * Basal Algorithm will suspend for low or dropping BG. Can stay suspended as long as necessary.
* Consider using secondary target- Higher for overnight the night before to limit risk of lows prior to surgery.
* Discouraging unannounced bedtime snack to build blood sugar before bed- can increase risk of overnight lows.
* If they need to remove the pump or CGM for surgery, the HCP can discuss MDI options. Transition back to iLet should be at least 90 minutes after last rapid acting bolus.
npatient considerations- iLet’s ability to continuously adapt based on real time CGM readings may promote improved glycemic control in a changing environment as compared to other delivery devices with settings. Furthermore, the simple meal announcement feature may make dosing by a caregiver less stressful and safer as compared to devices that require carb counting and increased button pushes. Encourage announcing based on what is Usual for patient, not hospital intake. For unreliable PO intake, consider announcing a Less Than at the start of meal and adding another Less Than within 30 minutes if full meal is tolerated.
How might you respond to a provider who has questions about ETOH intake on the iLet?
- The messaging is the same as all people with Diabetes- alcohol intake increases risk of hypoglycemia and in the case of severe hypoglycemia glucagon may not be as effective
Advise provider to: - Enable all low alerts on phone and iLet. Respond to alerts appropriately and immediately.
- Discourage unannounced bedtime snack to build blood sugar before bed- can increase risk of overnight lows.
- Temp basal is not necessary as we are not treating targets based on previously defined settings.
- Insulin suspension time has no limit and therefore may offer more low protection than other insuin delivery devices.
What might you say to a provider who argues that iLet isn’t a bionic pancreas closed loop, or fully automated?
Many insulin delivery devices label themselves as closed loop and AID. Redirect HCP to focus on patient diabetes burden. Patients don’t care about the name, they care how it will impact their life. No other device will have less autonomous dosing because of the iLet. This is huge.
HCP Interaction: Focus on our patient profiles- use reports to demonstrate outcomes. Best to ask which insulin delivery device is preferred currently in clinic and show reports of iLet patients improving outcomes with less work who previously used their preferred system.
How to you handle exercise without an exercise mode?
We don’t offer exercise mode because we are not treating to a target range or looking 30-60 minutes into the future. We do not pivot from a prescribed setting. Instead, the iLet responds every 5 minutes based on real-time CGM values and trend arrows, preventing the need to manually intervene. Use competitive intelligence to compare algorithms between systems, specifically the basal algorithm.
What can I do if I can’t change settings when things aren’t going well? “Numbers are a lot easier to change than behaviors”
- Encourage HCP to recognize the long-term gains of positive behavior intervention as compared to short term gains of moving settings around.
Refer to Patient Management Deck and HCP Resource
- Most patients are not entering accurate carbs into their devices making insulin setting adjustment less accurate
- Some patients enter falsely lower carbs to prevent judgement of HCP- iLet is only asking about Usual intake- psychological impacts of being judged for your food choices.
- Some patients consistently over-ride dosing recommendations due to fear of lows or “rage bolusing” to treat hyperglycemia
- Settings are adjusted every 3 months- is this adequate to keep up with your patient’s changing needs?
What are the options for high insulin users? Your cartridge is too small.
- Refer to iLet Algorithm- Tmax time of 65 minutes is unique to iLet. Post Tmax of 65 minutes the iLet will give more insulin than other pump algorithms.
- iLet also goes beyond learned sensitivity if glucose is not responding. This is why we do well when patient is on steroids or sick.
Basal Tether- This was not tested, however any medication used in conjunction with the iLet is at the HCP discretion. - Refer to HCP Guide- Adding basal insulin can help reduce DKA risk in some patient populations but also can increase risk of lows as iLet suspension is less effective.
HCP Question: Would you like me to have our Medical Affairs team reach out to you to discuss options for this patient population?
What patients are appropriate for the iLet?
* Refer to Global Report Catalog for specific examples.
The iLet will work for any patient that is able to do care and feeding of the iLet and seeks improvement in glycemic control.
* Those who cannot physically fill cartridges and place infusion sets will need caregiver support
* Those who cannot consistently respond to alerts, keep iLet charged, keep insulin in iLet and wear CGM will need caregiver support
* Those who are uncomfortable having glucose in euglycemic range will require HCP encouragement to allow the iLet to do its job
How can I use the iLet with my patients who struggle with gastroparesis?
- Consider encouraging your patient to follow diet recommended to reduce symptoms such as smaller, more frequent meals that are lower in fat and fiber
- Consider delaying meal announcement until 15 minutes after first bite to better match peak insulin action time with slower digestion- NEVER announce more than 30 minutes after first bite
- Consider avoiding meal announcements and allowing correction algorithm to dose insulin in response to CGM rise- caution with higher carb intake and/or patients who are prone to over-treating lows as this can cause increased risk of lows.
- For unreliable appetite, consider announcing a Less Than at the start of the meal and adding another Less Than announcement if meal is fully consumed within 30 minutes of first bite.
How does the iLet handle patients on steriods?
- Increase in CGM values, even when patient exceeds historic insulin dosing, will encourage the iLet to adapt up dosing. The iLet is ALWAYS LEARNING.
- While the iLet begins to increase delivery right away in response to higher BGs, it can take about 24-48 hours for the basal and corrections to adapt up.
- As the steroids/hormones/stress decrease, the iLet will again respond to decreasing CGM values and adapt dosing downward.
- Keep alerts on, volume up and respond quickly.
How does the iLet handle shift workers?
- Meal Announcement Algorithm- Shift workers keep a similar eating pattern whether they are working or not working. While the times might change, generally the food they eat for meal one, two, or three of the day is around the same composition in terms of carbs whether they are on a day shift or a night shift.
- Basal Algorithm/Correction Algorithm- always adapting, therefore more likely to naturally adapt more efficiently than toggling between multiple basal programs.
Can my patients just skip meal announcements?
Consider risk of avoiding all meal announcements:
* Missing meal announcements when high carb meals are consumed can lead to higher highs, and then subsequent lows.
* Redirect focus on why patients do not pre-bolus for meals. Fear of incorrect carb counting, too much work to enter carbs in other devices, poor numeracy skills. Allow the iLet to reduce this burden. We have found that patients who traditionally miss pre-meal bolusing are doing an excellent job of announcing meals on the iLet.
* Taking some insulin up front at meals will generally mean they need less corrective insulin later, and if less corrective insulin is needed later, there will be less circulating IOB which decreases risks of hypoglycemia– this is true for patients on MDI or traditional AID systems
I don’t feel comfortable making back up plan recommendations without access to current settings
- Why would you want to provide a patient who is not comfortable counting carbs or lacks the numeracy skills to compute a carb ratio this information?
- Consider back-up dosing based on Usual meal size and adapted Usual meal doses as a more valuable tool to your patient.
Can I use the iLet on my patients who are pregnant?
Off Label Patient Profile: Pregnancy
* Refer to Medical Affairs
* The iLet was not tested in pregnancy specifically, therefore avoid recommendations for this patient profile.
* Target options do not match ADA goals in pregnancy
* Consider that despite best efforts to meet ADA goals during pregnancy, some patients may not be able to perform mathematical tasks or adequate entering of blood glucose into another device in manual mode. It is up to the HCP to select the best choice for each individual patient’s needs.
* We will always pull pharmacy benefits- It’s worth a try in a patient who is concerned about being locked in to DME warranty for 4 years if open to pregnancy in this timeframe.
HCP Question: Would you like me to arrange a call from our Medical Affairs department to discuss this further?
I’m concerned about the BG run mode.
- How often to your patients go off sensor for more than a few days? **Working on getting RWD on percent time in BG Run Mode.
- When in manual mode do, your patients maintain safe glycemic control?
- Compare this time to the amount of time they are spending on an insulin delivery device that is not allowing them to meet glycemic goals.
- PUSH PSYCHOLOGIAL BURDEN
HCP Question: What is better- Poor diabetes management most of the time in order to have a manual mode emergency option or improved outcomes most of the time?
Medtronic has higher TIR / better algo (90%), and it’s not much to input carbs to get that
* Refer to RWD
Medtronic has higher TIR / better algo (90%), and it’s not much to input carbs to get that
* Refer to RWD
Medtronic is an option for those who are capable of managing a complex device and sensor and have the desire to put in the effort required to maintain it. The iLet is a good option for all people living with type 1 Diabetes over the age of 6, regardless of their abilities and personal bandwidth to devote to diabetes care every single day.
The iLet causes hypos or The iLet algorithm was programmed for dual hormone and since no glucagon yet, patients go low
- Unfortunately, no therapy at this time completely eliminates hypoglycemia (refer to post-market data)
- We’ve learned a tremendous amount on how to best train patients to get optimal results on the iLet, including minimizing hypoglycemia
- Psychological studies suggest patients experienced fewer fears of lows on the iLet
The iLet is only for out of control patients.
The iLet is only for out-of-control patients
* RWD- Both our pivotal trial and post market data review show the iLet has improved A1c in those poorly controlled as well as sustained control in those who were already meeting ADA goals.
* Use RWD approved slides to show results across all starting A1c levels
* Use clinic current patients or Global Report Database to show national patient success reports
HCP Question: Consider asking your controlled patients if they are happy with the level of effort required to maintain that control. Would you consider introducing the iLet to any patient who has >8% A1c for the past 2 visits with you?
The iLet lowers A1c too quickly which can cause issues for the patient.
* Retinopathy concerns
- Per Med Affairs, there are no reports of any patient using the iLet having worsening diabetic retinopathy in any users, however we did not specifically test for that in the Pivotal Trial.
- Dr. Russell: “Nobody disputes that better glucose control reduces the risk of retinopathy in the long run. The question is whether there’s a transient worsening. I’ve done a literature review on this and the expert recommendation is to get A1c down as quickly as possible and engage an ophthalmologist to help manage any complications.”
Worsening retinopathy with improvement in glycemic control article
HCP Question: Although it may be ideal to improve glycemic control prior to starting the iLet, consider if this is even possible for your patient. Would leaving your patient with long term complications be better than providing them a tool to fit their needs and improve control now?
The algorithm generally works fine if you do the same thing every day and it’s “best not to touch it” and it’s not good for those that like to “fine tune their insulin delivery”
- The iLet was designed with diabetes burden in mind. The continuously learning algorithm does the “fine tuning” for the patient. Although some patients find it more difficult than others to let go of this burden, most realize that the iLet is more successful than they are at doing the fine tuning.
Can iLet be used with MRI, CT scan, bipolar vs monpolar cautery
- To be safe it is best to stick with the advice in our User’s Guide that our device be removed for all these procedures including cautery. We have not tested the device in a clinical environment on patients with this equipment applied to the patient.
- Per the iLet User’s Guide, XRAY/CT/MRI/Diathermy are covered here, and I realize cautery is not specifically covered, but is like diathermy and device and site should be removed
- CGM- defer to each individual user guide
Patients are all over place in real world – iLet works well for some while others are up and down / high and low
- Our RWD has shown that all patients, regardless of starting A1c can achieve very similar results, all averaging at an A1c of 7.5%. This matches our Pivotal Trial results where we were able to show that socioeconomic status, age, gender, race and education level also were not a factor.
- We have targeted a handful of behavioral influencers that impact glycemic control
I am hearing the iLet causes a lot of hypo
Pivotal trial data demonstrated that the iLet did not cause an increase in hypo during the 13 week trial, and real word data shows 0.28% average time <54. In our RWD, adults showed a reduction in fear of hypo and had reduced diabetes specific emotional distress while using the iLet
My patients want a tubeless pump
I get it! What patients also want is convenience freedom, and not being reminded they have DM. Our RWD shows that teenage patients reported they thought less about DM and child participates reported they could eat more freely.
I am hearing the iLEt cannot help pt’s achieve a A1c lower than 7%
Pts want to be able to achieve good glycemic control w/ minimal fear of hypo and burden of DM management. Our pivotal data demoed that pts who had a low A1c were able to maintain that with less work. Our RWD supports the findings of the pivotal trial and further demos the effectiveness of the algorithms across multiple pt cohorts to be able to achieve repeatable, improved glycemic contol
