Intensifying insulin therapy is challenging

The best device is one people actually use
About CeQur Simplicity

Challenges with Insulin Therapy

Insulin works:

57%
self-reported intentional omission of insulin6

Insulin remains to be a critical therapy for the management of diabetes despite the introduction of novel therapies. A basal and mealtime insulin is often required to achieve glucose control. Insulin is a critical therapy for type 2 diabetes:

  • 53% require insulin therapy after 6 years of diagnosis1
  • 29.1% of the US diabetes population is on insulin2
  • Control of mealtime hyperglycemia, in addition to fasting hyperglycemia, has been shown to be crucial in reaching A1C goals of <7.0%3

Intensifying insulin therapy is challenging:

  • 2.4 million people with type 1 and type 2 diabetes are on mealtime insulin in the US4
  • 2/3 of people with diabetes on insulin are not at goal2 (Target A1C <7%)5
73%
of physicians report that their patients do not take their insulin as prescribed7

Barriers to adherence include;6

  • having to take multiple injections
  • interference of injections with daily activities
  • injection pain
  • public embarrassment

Missed mealtime dose impact on A1C

Missed insulin doses are common, and an important factor in poor glycemic control. Mealtime doses are especially important, and are often omitted3

  • 57% self-reported intentional omission of insulin6
  • 73% of physicians report that their patients do not take their insulin as prescribed7
  • A study found that for every 4 mealtime doses that are missed, there is a nearly 1% increase in A1C8

CeQur develops preferred solutions for insulin delivery

  • Simple to use: People with diabetes want to eliminate the daily injection burden and want a therapy that will fit into their life. HCPs believe adherence to multiple daily injections is a challenge and want insulin delivery that is easy to teach and use.
  • Discreet: People with diabetes are very concerned with how noticeable their insulin treatment is. They want a mode of insulin delivery they can use without others noticing.
  • Effective: Insulin as an effective therapy depends on a regimen that is easy to follow and adhere to. People using insulin admitted to skipping doses, stating that injections were a pain and the majority do not like injecting themselves 3-6 times per day. HCPs also acknowledged the challenge of adherence and finding a dosing regimen that their patients can follow.
  • Safe: HCPs are concerned with safety. They want insulin delivery that can protect the user from inadvertent dosing and notify the user if the device needs to be changed. They also need to be comfortable that these devices are reliable and provide accurate dosing.

CeQur has a platform of simple, wearable, 3-day devices that have been developed to provide the benefits of newer, technologically advanced insulin therapies without their complexity and up-front expense. These devices have been designed to reduce the barriers and challenges of daily insulin injection therapy to enable people to achieve target glycemic control.

Treating with PAQ®

CeQur Simplicity

FDA CLEARED, NOT YET AVAILABLE

CeQur Simplicity, Simple 3-day Bolus Insulin Delivery

Allows your patients to stay in the moment without the tradeoff.

Wearable, discreet and injection-free dosing

  • People using the Patch are more likely to dose mealtime insulin9
  • People using the Patch can dose anytime, anywhere

Wearable

  • Worn on their side for up to 3 days, so people have less worry about forgetting their insulin
  • No pens, needles, syringes, wipes need to be remembered and carry along
  • Waterproof design safe for showers, bathing, or swimming
CeQur Simplicity attaches to skin as a wearable insulin delivery device.

Discreet

  • A subtle squeeze through clothes allows dosing in any situation
  • Dual button action avoids accidental dosing
  • Low profile is easily concealed beneath clothing
Mealtime injection-free dosing can be discreetly delivered over clothing.

Injection-free dosing

  • A soft cannula delivers insulin, so there are no painful mealtime injections
  • The soft cannula differs from "floating needles" in other devices that can pinch or poke
  • Each click delivers 2 units of insulin
A flexible cannula is inserted in the skin beneath the device, so insulin can be delivered without dosing injections.

Improved Acceptance by Insulin Users

  • CeQur Simplicity allows people to dose discreetly in public, makes it easier to dose insulin and helps them to follow their insulin regimen.
    • 98% said they could dose discreetly in public9
    • 88% of study patients told it helps them do a better job of following their insulin regimen9
  • Less interference of injections with daily activities
    • 87% agreed that they could do things at the spur of the moment10
    • 91% agreed that they always had mealtime insulin with them10
  • Less injection pain
    • 90% agreed that taking mealtime insulin was painless10
  • Less embarrassment
    • 94% agreed that they could dose without attracting attention10
    • 89% agreed that they felt more comfortable using it socially10
  • Preferred by People with Diabetes – 3 out of 4 (76%) study patients would choose to switch from pen or syringe to the Patch11

More Effective Outcomes

Glucose control in controlled clinical trials

  • In a 6-week controlled, cross-over study (n=38) powered to show non-inferiority in blood glucose levels compared to pen/ syringes, patients on the Patch had a trend towards improved control and showed significantly less glycemic variability.11
  • In a 48-week controlled, cross-over study (n=278) powered to show non-inferiority in A1C levels compared to pen, baseline A1C of patients on the Patch decreased 1.7% at week 24 and this reduction was maintained at week 44.10

Simple to use and train

  • Most HCPs reported that the Patch was easy to use, and only required a short time for subject training10
  • Compliments the existing basal therapy, so there is no need to adjust basal rates

Safe

  • 2-button mechanism ensures dosing occurs only when intended
  • Buttons lock in “squeezed in” position when empty or if cannula is occluded
  • Benchtop performance showed that the bolus-only patch is a safe, accurate, and reliable device for mealtime insulin delivery.12

Because the best device is one people actually use.

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References

  1. Wright A, Burden ACF, Paisey RB, Cull CA, Holman RR, and the UK Prospective Diabetes Study Group. Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57). Diabetes Care. 2002;25: 330-336.
  2. Selvin E,Parrinello CM, Daya N, Bergenstal RM. 2016. Trends in Insulin Use and Diabetes Control in the U.S.;1988-1994 and 1999-2012. Diabetes Care. 39(3):e33-e35.
  3. Peyrot M, Bailey T, Childs B, Reach G. 2018. Strategies for implementing effective mealtime insulin therapy in type 2 diabetes. Current Medical Research and Opinion. 34(6):1153-1162.
  4. Health Advances LLC. 2017 Simple Infusion Device Market Model., Health Advances interviews and analysis. Confidential–Not for Distribution Without Permission from CeQur SA and Health Advances LLC.
  5. American Diabetes Association. 2018. Glycemic Targets: Standards of Medical Care in Diabetes—2018. Diabetes Care. 41(Supplement 1):S55-S64.
  6. Peyrot M, Rubin R, Kruger D, Travis L. 2010. Correlates of Insulin Injection Omission. Diabetes Care. 33(2):240–245.
  7. Peyrot M, Barnett A, Meneghini L, Schumm‐Draegeral P. 2012. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy Study. Diabetic Medicine. 29:682–689.
  8. Chase HP, Horner B, McFann K, Yetzer H, Gaston J, Banion C, Fiallo-Scharer R, Slover R, Klingensmith G. 2010. The use of insulin pumps with meal bolus alarms in children with type 1 diabetes to improve glycemic control. Diabetes Care. 29(5):1012-1015.
  9. Zraick V, Dreon D, Nalk R, Shearer D, Crawford S, Bradford J, Levy B. 2016. Patient User Experience Evaluation of Bolus Patch Insulin Delivery System. Poster presented at the American Diabetes Association’s 76th Scientific Sessions. Abstract 995-P. New Orleans, LA, USA.
  10. Bergenstal R, Peyrot M, Dreon D, Aroda V, Bailey T, Brazg R, Frias J, Johnson M, Klonoff D, Kruger D, Ramtoola S, Rosenstock J, Serusclat P, Weinstock R, Naik R, Shearer D, Zraick V, Levy B on behalf of the Calibra Study Group. 2019. Implementation of Basal-Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch with and Insulin Pen. Diabetes Technology and Therapeutics 21 (5):1-13.
  11. Bohannon N, Bergenstal R, Cuddihy R, Kruger D, List S, Massaro E, Molich M, Raskin P, Remtema H, Strowig S, Whitehouse F, Brunelle R, Dreon D, Tan M. 2011. Comparison of a Novel Insulin Bolus-Patch with Pen/Syringe Injection to Deliver Mealtime Insulin for Efficacy, Preference, and Quality of Life in Adults with Diabetes: A Randomized, Crossover, Multicenter Study. Diabetes Technology & Therapeutics. 13(10):1031-1037.
  12. Dreon D, Hannon T, Cross B, Carter B, Mercer N, Nguyen J, Tran A , Melendez P, Morales N, Nelson J, Tan M. 2018. Laboratory and Benchtop Performance of a Mealtime Insulin-Delivery System. Journal of Diabetes Science and Technology. 12(4):817-827.

Additional Reading

* Humalog® is a registered trademark of Eli Lilly and Company. NovoLog® is a registered trademark of Novo Nordisk A/S.

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