AACE Callout

AACE 28th Annual Scientific & Clinical Congress

Join us for a reception Tuesday, April 23rd in Los Angeles.

PAQ MEAL Callout

PAQ MEAL

Convenient, discreet mealtime insulin dosing for people with diabetes.

PAQ TOTAL Callout

PAQ TOTAL

Convenient, discreet mealtime insulin dosing for people with diabetes, with the added control of selectable basal rate insulin.

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 of 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 PAQ® are 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 PAQ® 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.

APPROVED, NOT YET AVAILABLE

PAQ MEAL, 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 PAQ MEAL are more likely to dose mealtime insulin9
  • People using PAQ MEAL 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
PAQ MEAL 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

  • PAQ MEAL 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 PAQ MEAL11

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 PAQ MEAL 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 PAQ MEAL decreased 1.7% at week 24 and this reduction was maintained at week 44.12

Simple to use and train

  • Most HCPs reported that PAQ MEAL 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.13

Because the best device is one people actually use.

NOT YET APPROVED

PAQ TOTAL, Simple 3-day Basal-Bolus Insulin Delivery

Introduction to PAQ TOTAL™

PAQ TOTAL is a wearable insulin delivery device that delivers up to 3 days of continuous pre-set basal insulin plus on- demand mealtime bolus in 2 unit increments.

PAQ TOTAL has two components:

The Insulin Resevoir is the base of the device, which attaches to the skin and delivers the basal and bolus doses.

Insulin Reservoir

  • Delivers 3 days of steady basal insulin
  • Provides injection-free bolus with a push of the button
The Messenger Unit is transferred to new Insulin Resevoirs and is the alert module that signals the user about key events.

Messenger

  • Notifies wearer when to replace the insulin reservoir
  • It is a reusable unit that is with new reservoirs

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PAQ TOTAL & Its Benefits

    PAQ TOTAL is available in a variety of pre-set basal-rates, which is selected to match the patient's need.
  • Developed specifically for people with type 2 diabetes
  • Up to 3 days of continuous subcutaneous insulin delivery
  • No programming or infusion sets
  • Worn on the abdomen
  • Small, ergonomic design
  • Be active, sleep, eat, exercise
  • Bathe, shower, swim (depth up to 6 ft)
  • Utilizes U100 rapid-acting insulin (i.e. Humalog®, Novolog®)*
  • 7 preset basal doses (you need to choose the best rate for your patient)
  • 2 bolus units delivered with each button push
  • Delivers up to 330 units over 3 days

Recent Clinical Results

Findings from two studies evaluating the company’s PAQ TOTAL™ Insulin Delivery Device among people with type 2 diabetes. The data demonstrate that the simple, three-day, wearable basal-bolus insulin delivery device significantly improved glycemic control among people with type 2 diabetes who transitioned to the device. Study participants also reported increased treatment satisfaction with the device as compared to insulin injections.

Challenges to Reaching Goal

  • 1.4 million people with type 2 diabetes in the United States take multiple daily insulin injections to control their blood glucose levels (A1C)4
  • Clinical practice guidelines published by the American Diabetes Association generally point to A1C levels below 7 percent (53 mmol/mol) as reasonable targets to help prevent diabetes complications5
  • 2/3 of insulin users in the United States do not achieve this goal, primarily due to missed insulin injections2

Findings Published in Journals

1.5%
average reduction in A1C14
  • After 12 weeks of use, results showed significant improvements from baseline with an average reduction in A1C of 1.5 percent14
    • By comparison, patients in the multiple daily injection arm of several recent randomized, controlled studies, experienced an A1C decrease of ∼0.4 percent or ∼4mmol/mol14

Delivery Preference

  • The total Diabetes Treatment Satisfaction Questionnaire (DTSQ) score significantly improved at the end of the treatment period as compared with baseline14
  • Patients saw the PAQ TOTAL device as more convenient than baseline therapy and were more satisfied to continue treatment14

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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. Levy B, Zraick V, Weinstock R, Serusclat P, Rosenstock J, Ramtoola S, Peyrot M, Kruger D, Klonoff D, Frias J, Dreon D, Brazg R, Bergenstal R, Bailey T, Aroda V for the Calibra Study Group. 2018. User- and Healthcare Provider-Reported Outcomes for a Wearable Bolus Insulin Delivery-Patch. Poster presented at the 54th European Association for the Study of Diabetes (EASD 2018) Annual Meeting. Berlin, Germany.
  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. Ramtoola S, Zraick V, Weinstock R, Serusclat P, Rosenstock J, Peyrot M, Levy B, Kruger D, Klonoff D, Frias J, Dreon D, Brazg D, Bergenstal R, Bailey T, Aroda V for the Calibra Study Group. 2018. Optimizing Basal–Bolus Therapy in Type 2 Diabetes: A Randomized Controlled Trial Comparing Bolus Insulin Delivery Using an Insulin Patch vs an Insulin Pen. Poster presented at the 54th European Association for the Study of Diabetes (EASD 2018) Annual Meeting. Berlin, Germany.
  13. 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.
  14. Mader JK, Lilly L, Aberer F, Poettler T, Johns D, Trautmann M, Warner J, Pieber T. 2018. Improved glycaemic control and treatment satisfaction with a simple wearable 3‐day insulin delivery device among people with Type 2 diabetes. Diabetic Medicine. 35(10):1448–1456.

Additional Reading

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

All Site References