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CGM

1. Continuous Glucose Monitoring (CGM) Dr.Yassin M Alsaleh

2. Introduction diabetes mellitus (DM) is a multisystem disease with both biochemical and anatomic/structural consequences. Diabetes is accounting for significant morbidity and mortality, and diminished quality of life for masses of affected individuals and their families The importence of achieving normoglycemia (or near- normoglycemia ) is well-established .

3. Introduction many medical organizations have established aggressive targets for glycemic control in individuals with diabetes. to meet these targets without hypoglycemia is difficult . severe hypoglycemia remains an ongoing threat to personal safety and well-being .

4. Introduction patients may overtreat hyperglycemia as well as overtreat low glucose levels.  even in “ well-controlled” patients with Type-1 or Type-2 diabetes, significant time is spent above and below desired target ranges .

5. Monitoring The blood sugar of a person with diabetes is continuously changing every minute of the day throughout the person’s life. In the 1970s, blood glucose meters became available and transformed the nature of diabetes self-monitoring.

6. Monitoring Patients may use glucometers to check blood sugar, but this gives the value of blood sugar only at the particular time when the test is done. 60% of glucose lows may not be revealed with self-monitoring of blood glucose (SMBG) alone

7. Monitoring Another standard way to monitor blood glucose is through the measurement of HbA1c. it does not give a correct picture of how much fluctuations occur. Thus, while SMBG and HbA1c are important—they do not tell us the complete picture—especially information on glycemic variability of the patient

8. Monitoring Understanding glucose variability in a patient is extremely important. some research suggests that variable blood sugars may be more damaging than consistently high blood sugars. Fluctuations of glucose values can lead to oxidative stress and potentially to cell damage and increased risk for microvascular and macrovascular complications.

9. Continuous glucose monitoring (CGM) There is a clear need for better tools to enable patients and clinicians to improve glycemic control. Research suggests that consistent use of CGM can reduce HbA1c levels, glycemic variability and the frequency, duration and magnitude of hypoglycemic events. Continuous glucose monitoring (CGM) can help complete the picture for a patient’s glucose control.

10. Continuous glucose monitoring (CGM) CGM is a useful tool in pump users, non-pump users. in type 1 diabetes, and those with complex type 2 diabetes. It reads the sugar levels of the person every 10 seconds and keeps a record every 5 minutes A tiny, sterile, flexible electrode is inserted just under the skin that measures glucose in the interstitial fluid (ISF).

11. BASICS OF CONTINUOUS GLUCOSE MONITORING Glucose in the ISF penetrates the semipermeable membrane of the sensor and reacts with the glucose oxidase found within the sensor. This reaction produces electrons, which are measured as what we call the input signal (ISIG) This ISIG is then converted into the sensor glucose value by using calibration blood glucose values.

12. Review of the literature In type 1 diabetes, CGM systems are associated with 0.5–1% reduction in HbA1c without increased risk of hypoglycemia. CGM efficacy correlates with compliance to sensor wear , whatever the patient’s age range . Efficacy of CGM systems is now proven but indications, terms of use and educational issues of this new technology still need to be specified

13. Review of the literature CGM increased time spent in normoglycaemia and reduced severe hypoglycaemia in patients with type 1 diabetes and impaired awareness of hypoglycaemia , compared with SMBG. CGM reduces most GV indices compared with SMBG in people with type 1 diabetes.

14. Recommendations The Standards of Medical Care in Diabetes ADA (2016)  When used properly, CGM in conjunction with intensive insulin regimens is a useful tool to lower A1c in selected adults (aged ≥25 years) with type 1 diabetes.  Although the evidence for A1c lowering is less strong in children, teens and younger adults, CGM may be helpful in these groups. Success correlates with adherence to ongoing use of the device.  CGM may be a supplemental tool to SMBG in individuals with hypoglycemia unawareness and/or frequent hypoglycemic episodes.

15. An Endocrine Society (2016 ) We recommend real-time continuous glucose monitoring (RT-CGM ) devices for adult patients with T1DM who haveA1Clevels above target and who are willing and able to use these devices on a nearly daily basis. We recommendRT -CGM devices for adult patients with well-controlled T1DM who are willing and able to use these devices on a nearly daily basis . We suggest short-term, intermittent RT-CGM use in adult patients withT2DM(not on prandial insulin)who have A1C levels 7% and are willing and able to use the device .

16. AACE/ACE clinical practice guidelines ( 2015) CGM may be considered for patients with type 1 diabetes and type 2 diabetes on basal-bolus therapy to improve A1c levels and reduce hypoglycemia . Although data from small-scale randomized trials and retrospective or prospective observational studies suggest CGM may provide benefits in insulin-using patients with type 2 diabetes, additional research is needed before recommendations can be made regarding use in this patient population

17. Types of Continuous Glucose Monitoring Systems

18. Indication the American Association of Clinical Endocrinologists ( AACE ) recommends personal CGM for the following patients : Those with type 1 DM and the following characteristics: Hypoglycemic unawareness or frequent hypoglycemia Hemoglobin A1c (HbA1c) over target, or with excess glycemic variability ( eg , hypoglycemia judged to be excessive, potentially disabling, or life-threatening ) Requiring HbA1c lowering without increased hypoglycemia. During preconception and pregnancy Children and adolescents with type 1 DM who have achieved HbA1c levels less than 7.0% (these patients and their families are typically highly motivated) Youth with type 1 DM who have HbA1c levels of 7.0% or higher and are able to use the device on a near-daily basis

19. Indication The following patients might be good candidates for personal CGM, and a trial period of 2 to 4 weeks is recommended: Youth who frequently monitor their blood glucose levels. Committed families of young children (younger than 8 years), especially if the patient is having problems with hypoglycemia

20. Diagnostic use Suspected Nocturnal hypoglycemia/dawn phenomenon Hypoglycemia unawareness Postprandial hyperglycemia Suspected unrecognised hypoglycaemia eg exceptionally low HbA1c without reported hypoglycaemia HbA1c above individualised target despite intensified insulin therapy apparently optimised with self-monitoring

21. Diagnostic use Persistent disabling hypoglycaemia despite conversion from MDI to CSII In pregnancy when HbA1c > 6.1% or problems with recurrent hypoglycaemia despite optimised intensive insulin therapy Further optimisation of pump therapy regimens when HbA1c cannot be consistently lowered below 7.5% (or 6.1% in pregnancy) Protection against recurrent disabling hypoglycaemia , and for those with hypoglycaemia unawareness or debilitating fear of hypoglycaemia

22. Benefits Continuous glucose readings allow patients to better manage their diabetes by intervening on a real-time basis to reduce the frequency and severity of hypoglycemic or hyperglycemic episodes . Patients can learn how diet, exercise, medication, lifestyle and episodes of illness affect their glucose levels. historical analysis provides insights for both patients and health care professionals (HCPs) that can be translated into treatment adjustments and optimization .

23. drawbacks System inaccuracy: disruptive alarms. Discomfort. costs

24. System inaccuracy It is important to recognize that there is a lag between the blood and interstitial glucose levels of at least 15 minutes. The absolute value should be confirmed with a capillary blood glucose measurement before taking any therapeutic action.

25. Discomfort needle used to insert them can cause momentary pain. Use of the mechanical insertion devices that accompany the sensors helps to ensure proper/rapid insertion and minimal discomfort. Insertion at the appropriate angle (not too sharp or close to the skin surface) also reduces choosing an insertion site that has adequate subcutaneous fat (not near bone, scar tissue or muscle) can improve comfort considerably.

26. references 1- Dr Cornelis A J van Beers . Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised , open-label, crossover trial.the lancet diabetes and endocrinology Volume 4, No. 11 , p893–902, November 2016. 2- Lucisano J, et al . Glucose Monitoring in Individuals with Diabetes using a Long-Term Implanted Sensor/Telemetry System and Model. IEEE Trans Biomed Eng. 2016 . 3- Gómez AM, et al. Long-Term Efficacy and Safety of Sensor Augmented Insulin Pump Therapy with Low-Glucose Suspend Feature in Patients with Type 1 Diabetes . Diabetes Technol Ther . 2016

27. references 4- El- Laboudi AH, et al. Measures of Glycemic Variability in Type 1 Diabetes and the Effect of Real-Time Continuous Glucose Monitoring .. Diabetes Technol Ther . 2016 . 5- Kovatchev B, et .Feasibility of Long-Term Closed-Loop Control: A Multicenter 6-Month Trial of 24/7 Automated Insulin Delivery .. Diabetes Technol Ther . 2016 6- Andrea Facchinetti . Continuous Glucose Monitoring Sensors: Past, Present and Future Algorithmic Challenges. Sensors (Basel ).; 16(12): 2093 . 2016 Dec

28. references 7- Nicole C. Foster .Continuous Glucose Monitoring in Patients With Type 1 Diabetes Using Insulin Injections. April 19, 2016 8- Satish K. Garg , MD. The Future of Glucose Monitoring. DIABETES TECHNOLOGY & THERAPEUTICS. Volume 18, Supplement 2, 2016 9- M . Joubert . Personal continuous glucose monitoring (CGM) in diabetes management : Review of the literature and implementation for practical use. d i a b e t e s r e s e a rch and cl i n i cal p r a c ti c e 9 6 ( 2 01 2 ) 29 4 – 30 5

29. references 10- Anne L. Peters, Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab , November 2016. 11- Stanley Schwartz, MD . The Role of Continuous Glucose Monitoring in the Management of Type-1 and Type-2 Diabetes. Evidence Based Management of Diabetes, 2012

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