Continuous Insulin Pump Therapy present & Future. Dr. Abdulmoein Al-Agha, Pediatric Endocrinologist

Transcription

1 Continuous Insulin Pump Therapy present & Future Dr. Abdulmoein Al-Agha, Pediatric Endocrinologist

2 Banting and Best

3 Convergence Toward Automation I n s u l i n D e l i v e r y 1921 Insulin 1979 Pumps We are here Open Loop Closed Loop M on i t o ri 1971 Home Monitors Advice/Feedback Continuous Monitors n g 1926 tasting the urine HCP Self Management Automation

4 Pumps Have Come A Long Way ( )

5 The Pump Mimics the Pancreas Meal Boluses Adjustable Basal Rate

6 Classic Pump Features More physiologic insulin delivery to mimic the pancreas Basal: steady background insulin delivery to keep BG from rising while fasting Bolus: spurts of insulin to cover carbs or lower high BGs

7 Benefits of Insulin Pump Therapy Improved glycemic control Less frequent / severe hypoglycemia Enhanced quality of life Improved patient satisfaction Ease of management Reduced glucose toxicity, which may also result in improved β-cell function Hb A 1C

8 Current CSII Candidate Selection Patient Requirements Motivated to take insulin Educated and reliable parents Willing to monitor and record BG Willing to quantify food intake Carb counting Willing to follow-up

9 Consensus Statement on Pump Use in Pediatric- Patient Selection Recurrent severe hypoglycemia Wide fluctuations in glucose readings regardless of A1c Suboptimal diabetes control Micro/macro vascular complications Good control but regimen compromises lifestyle Infants and neonates Children with needle phobia

10 Where Are We?? Today s Smart Pumps Open Loop Pumps

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12 Interstitial Fluid Measurement Interstitial fluid glucose (G2) is almost always comparable with blood glucose (G1)

13 The insulin pump is controlled by the pump user to bolus manually based on a recent blood glucose measurement and an estimate of the grams of carbohydrate consumed. This predictive approach is said to be open-loop Once a bolus has been calculated and delivered, the pump continues to deliver its basal rate insulin in the manner that has been programmed into the pump controls based on the predicted insulin requirements of its user

14 Pumps Offer More Normal Lifestyle Liberalization of diet timing & amount (by user) Increased control with exercise (by user) Able to work shifts & through lunch (by user) Less hassle with travel and time zones (by user) Aid to weight control (by user) Less anxiety in trying to keep on schedule (by user)

15 Deficient Pump Issues Carb and correction boluses calculated by user Underestimating carbs in meals with inaccurate boluses 34% low before training 17% low after training No carb entry or database Boluses easy to forget No direct BG entry No exercise component

16 Smart Pump Boluses Carb boluses Accuracy improved with personal carb factor adjusted for different times of day Personal carb database Correction boluses Personalized correction factors for different times of day Safer correction of high BGs Reports amount of correction bolus used (ie, over 8% of TDD) An accurate TDD --> accurate basals & boluses

17 Carb Bolus Assistance Each manufacturer provides bolus dose recommendations differently.

18 Smart Pump Correction Boluses Average Summary screen from Cozmo history 6 day average: Meal u Corr u Basal u Total 54.09u Carb 175 g Here, correction boluses make up 21% of TDD When correction boluses make up more than 8 to 10% of the TDD, 1/3 of this amount is moved to basal rates or carb boluses (as long as hypoglycemia is not the primary problem).

19 Smart Pump Bolus On Board Bolus On Board (BOB) Discounts bolus for residual BOB Improves accuracy Avoids stacking of bolus insulin Acts as guide to whether carbs or insulin are needed, ie, BG is 130 mg/dl but BOB = 5 u Requires a blood sugar test, an accurate duration of insulin action, and BG targets Prevents hypoglycemia!

20 Smart Pump Reminders Reminders (alarms) to test glucose following a bolus test glucose after a low reading test glucose after a high reading give a bolus at certain time of day warn when bolus delivery was not completed, etc. change infusion site

21 Pump And Meter Combos Direct glucose entry into database eliminates data errors and offers optimum use of glucose/insulin data AccuChek Spirit + meter CozMore System + Therasense CoZmonitor Soill Diabecare III pump + meter Medtronic 515/715 + BD Paradigm Link Soon: Animas +? Lifescan or Glucowatch

22 Smart Pump Data Collection Current pumps track basals, boluses, blood sugars, carb intake, and timing (exercise/activity soon) Better analysis and many intelligent features, such as automatic testing of basals and boluses, can be done now with current pumps and meters

23 Limitation Currently there are no mature algorithms to automatically control the insulin delivery based on feedback of the blood glucose level When the loop is closed, the system may function as an artificial pancreas

24 Limitations No system is close to being used for a closed loop No current system can replace the finger stick monitor for real time glucose values and treatment decisions Current finger stick systems continue to be poorly accepted Well many companies are attempting to develop continuous glucose monitoring systems

25 Smart Pumps And Tomorrow s Intelligent Pumps

26 Future Development

27 Relatively large Wearable Pumps

28 Micro-pump Debiotech has been developing small pumps from Micro-Electro- Mechanical Systems or MEMS technology. These devices are made from silicon (not silicone!) and easily mass-produced to keep cost low. Silicon is harmless, but it is not clear how insulin may interact with silicon surfaces.

29 Insulin pump technology is to combine with a continuous blood glucose monitoring system 2 in 1 machine

30 Clinical trials: implantable insulin pumps and continuous glucose sensors

31 Insulin pumps for infusing synthetic Amylin with insulin for improved postprandial glycaemic control compared to insulin alone

32 Dual hormone insulin pumps that infuse either insulin or glucagon. In event of hypoglycemia, the glucagon could be triggered to increase the blood glucose. It would be particularly valuable in a closed loop system under the control of a glucose sensor

33 Ultrafast insulin which are absorbed more quickly than the currently available rapid acting insulin which have a peak at about 60 minutes It theoretically coordinate with meals better, and allow faster recovery from hyperglycemia if the insulin infusion is suspended. They are in development by Biodel Halozyme, and Novo Nordisk

34 Future Pump Features Automatic TDD adjustment Average blood sugar and standard deviation % TDD used for corrections Basal/bolus balance Automatic basal testing Overnight Daytime, when meal is skipped Automatic carb factor testing Premeal, 2 hr postmeal peak, normal in 4-5 hrs? Automatic correction factor testing High-to-normal in 4-5 hours?

35 Smart Versus Future Intelligent Devices Feature Smart Intelligent Carb list Alphabetic By recent use Basal/bolus testing By user Automatic Exercise adjustment By user Automatic Timer By user Automatic % of corr. bolus Ignored Automatic Super Bolus By user Automatic # of hypos By user Automatic

36 Our Dream!! An Artificial Pancreas Closed Loop System

37 Feedback of real-time blood glucose data to an insulin pump for basal & bolus control

38 Automated insulin pump basal control The first step in controlling an insulin pump based on continuous blood glucose data is to automatically control the basal rate of the insulin pump when the blood sugar is increasing, a small correction bolus can be automatically delivered and a higher basal rate can be set

39 when the blood sugar is decreasing, the basal rate can be halted to deny the quantity of insulin needed to bring the blood glucose level back up until the basal rate can be continued at a new lower rate; with adaptive filtering techniques, the pump can "learn" the unique basal rates for the person as a function of the time of day

40 Automated insulin pump for bolus control Closed loop can still correct a meal bolus error that was too large or small for the food consumed by: recognizing an imbalance between the bolus "insulin on board" and the level of blood glucose, automatically bolusing to correct a shortage of insulin, automatically reducing or interrupting the basal rate to correct an abundance of insulin, using adaptive filtering techniques to "learn" the carbohydrate to insulin ratios for each meal bolus

41 Final Notice In USA in 2006, Juvenile Diabetes Research Foundation launched a multiyear initiative to help accelerate the availability of an artificial pancreas to people with diabetes Several companies are working on clinical acceptance, including Medtronic Diabetes (MiniMed), Johnson & Johnson (Animas) and Insulet. artificial pancreas design

42 Final Notice These companies have semi-automated closed-loop systems that check the glucose level using a CGM(Continuous Glucose Monitor), Some companies are also involved in potentially adding a glucagon pump to these systems in an effort to avoid hypoglycemia

43 One company, called Pancreum, has recently won an award for its artificial recently won an award for its artificial pancreas design

44 Thanks