Our Pipeline - Products in Development

While much of our externally visible efforts are to prepare for the launch of CeQur Simplicity™, our team of medical, design, and manufacturing professionals remain dedicated to the launch of our pipeline. We will continue to provide updates on this progress through our press releases and email communications. The sections below provide more details of products under development.

CeQur PAQ Device

CeQur PAQ®

This device is not yet cleared for use in the United States.

A simple 3-day wearable basal-bolus insulin device.
— Significantly improved glycemic control among people with type 2 diabetes
— Participants reported increased treatment satisfaction with CeQur PAQ versus insulin injections

The CeQur PAQ Device

CeQur PAQ device in development 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.

CeQur PAQ 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 transferred to each new insulin reservoir

To receive updates about this product, please join our mailing list, below.

CeQur PAQ & Its Features

    CeQur PAQ 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 (your doctor will choose the best rate for you)
  • 2 bolus units delivered with each button push
  • Delivers up to 330 units over 3 days

Recent Clinical Results

Findings from a studies evaluating the company’s CeQur PAQ 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)2
  • 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 complications3
  • 2/3 of insulin users in the United States do not achieve this goal, primarily due to missed insulin injections4

Findings Published in Journals

1.5%
average reduction in A1C1
  • After 12 weeks of use, results showed significant improvements from baseline with an average reduction in A1C of 1.5 percent1
    • 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/mol1

Delivery Preference

  • The total Diabetes Treatment Satisfaction Questionnaire (DTSQ) score significantly improved at the end of the treatment period as compared with baseline1
  • Patients saw the CeQur PAQ device as more convenient than baseline therapy and were more satisfied to continue treatment1

Importance of Glucose Control

The HbA1c (commonly called A1C) is an average of what your blood sugar levels have been over the past three months. In general, the higher your A1C number, the higher your risk for diabetes complications. (A high A1C means there is too much sugar in your blood and your body isn’t absorbing it.)

Your body uses insulin to allow sugar to enter into your cells. Diabetes is very complicated, but essentially the cells of your body are not properly fed which can lead to complications. Insulin has been used for over 90 years as a life-saving treatment for people with diabetes. While many advancements have been made over the years regarding the types of insulin and how it has been administered, there are basically two modes of use – basal and bolus. Basal is the small amounts of insulin that your body needs all day long, even while you are asleep. Even when you don’t eat (fasting) your body is still releasing sugar into your blood, mostly stored and released by your liver. Bolus insulin is a short-term dose needed at mealtime to help your body absorb the increase in blood sugar that occurs when you eat. For some patients a basal and bolus insulin is needed to manage blood sugar levels all day long. How well you manage your blood sugar levels each day determines your A1C score, since it is an average of the past 90 days.

Insulin is a protein molecule produced in your pancreas. Different types of insulin are now produced in a variety of ways to provide insulin for people whose bodies don’t produce enough or any insulin. Since it is a protein, insulin cannot be taken orally because it would be digested in your stomach the same way other proteins that you eat are digested. Therefore, insulin must be injected into your body to enter your bloodstream. This requires needles or other methods for dosing. CeQur understands that needles and devices can add to the complexities of managing your diabetes, so our mission is to make insulin therapy simpler, more convenient, effective and safe.

References

  1. 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.
  2. 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.
  3. American Diabetes Association. 2018. Glycemic Targets: Standards of Medical Care in Diabetes—2018. Diabetes Care. 41(Supplement 1):S55-S64.
  4. 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.

Additional Reading

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