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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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(Lee et al, 2007; Peyrot and Rubin, 2007; Buckingham et al, 2007b; Hirsch et al, 2007) Limitations of the studies noted by CADTH included: small patient populations, inexperienced pump users, selection of patients with poor baseline glycemic Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline control, and a possible overlap of patient populations. They also stated that the studies did not evaluate improvement or increased likelihood of reaching glycemic targets. Three uncontrolled studies demonstrated improvement in glycemic control or a reduction in symptomatic hypoglycemic episodes, or favorable acceptance and ease of use of the system (Pohar, 2007).

Several randomized studies are nearing completion or currently underway. The STAR I (Sensor Augmented Therapy for A1C Reduction) study, sponsored by Medtronic, has randomized a total of 144 diabetic patients with insulin pumps to receive continuous glucose monitoring devices or standard monitoring for a period of six months. Outcomes measures include reduction in hemoglobin A1c, frequency of hypoglycemia and quality of life. The STAR 3 study is a similarly designed randomized study focusing on diabetic patients not on insulin pumps. To date, these studies have not been published. (ECRI, 2007) Technology Assessment Reports Hayes, Inc.

There is evidence from a number of the available randomized controlled and crossover trials, as well as nonrandomized controlled studies, that use of continuous glucose monitoring (CGM) systems may contribute to improved glycemic control in adult patients with type 1 diabetes, although not all of the studies reported a significant difference between CGM and self-monitoring of blood glucose (SMBG). Results of studies of CGM devices in pediatric patients with type 1 diabetes were mixed; some studies reported significantly improved glycemic control and reduced incidences of hyperglycemia and hypoglycemia, while other studies reported no improvement in these or other outcome measures, such as glycosylated hemoglobin (HbA1c) levels. Studies of the use of CGM devices in pregnant women with either type 1 or gestational diabetes were limited but generally positive, with improved glycemic control or better differentiation between diabetics, nondiabetics, and those with impaired glucose tolerance associated with CGM. Only 2 studies addressed the use of CGM in adult type 2 diabetics and were insufficient to support conclusions regarding efficacy. Methodological flaws in some of the studies included small study populations, lack of adequate blinding, and very limited follow-up. Other shortcomings included lack of standardization of the duration of CGM and variation in the definition of hyperglycemic and hypoglycemic events. More importantly, there were limited data regarding the impact of CGM on long-term health outcomes or the impact on overall diabetic disease management decisions, such as treatment goals. Well-designed randomized controlled trials of CGM with extended follow-up are needed to confirm that CGM enables sustained and long-term improvements in glycemic control for adult patients, and to determine what role, if any, CGM should play in the management of pediatric patients or pregnant patients with type 1 or gestational diabetes. Further study is also needed to determine the optimal frequency and duration of CGM (Hayes, 2008) Hayes reviewed clinical evidence supporting the use of the closed-loop use of the Paradigm REAL-Time System and reported conclusions that the results of the two reviewed studies (Steil et al., 2006; Chee et al., 2006) failed to provide conclusive evidence that the closed-loop use of the system is a safe and effective method for blood glucose management (Hayes, 2007).

ECRI Institute ECRI assessed real-time continuous glucose monitoring in 2007 and found that the published data are very limited and primarily focus on the diagnostic performance of CGM systems. Despite the limitations in the data, ECRI believes that under close clinical supervision real-time CGM may benefit select populations of diabetes patients to track trends and patterns in glucose levels or assist the provider in unique situations when additional information is needed. This information can then be used to adjust diabetes management.

National Institute for Health and Clinical Excellence (NICE) NICE recommends the use of continuous glucose monitoring systems in adults on insulin therapy who have consistent problems with controlling blood glucose levels, notably repeated hyper- or hypoglycaemia at the same time of day or hypoglycaemia unawareness, unresponsive to conventional insulin dose adjustment. (NICE, 2008) Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline NICE also recommends that continuous glucose monitoring systems be available to children and young adults with type 1 diabetes who have persistent problems with impaired awareness of hypoglycemia or repeated hypoglycemia and hyperglycemia (NICE, 2004).

Professional Societies American Diabetes Association (ADA) Insulin pumps In a 2002 position statement the ADA states that both continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injection therapy are effective means of implementing intensive diabetes management with the goal of achieving near normal level of blood glucose and improved lifestyle flexibility. Rapid-acting insulin analogs (such as lispro) are appropriate insulins for insulin infusion pumps. Use of mixtures of insulins in pumps has not been evaluated and therefore is not recommended. Experience with insulin-pump therapy indicates that candidates for CSII must be strongly motivated to improve glucose control and willing to work with their health care provider in assuming substantial responsibility for their day-to-day care. Use of CSII requires care by skilled professionals, careful selection of patients, meticulous patient monitoring and thorough patient education. (ADA, 2004a) In a statement on the care of children and adolescents with type 1 diabetes, the ADA states that there is no best predetermined age to initiate insulin pump therapy. As with all diabetes management issues, individualized treatment plans that consider the needs of the patient as well as those of the family are best. Currently, there are fewer young children than preadolescents and adolescents using insulin pumps. Adult support at both home and school is essential for success with all diabetes management but especially with pump treatment until the child is able to manage the diabetes independently. (Silverstein, 2005) In a statement on gestational diabetes mellitus, the ADA states that insulin is the pharmacologic therapy that has most consistently been shown to reduce fetal morbidities when added to medical nutrition therapy (MNT). Selection of pregnancies for insulin therapy can be based on measures of maternal glycemia with or without assessment of fetal growth





characteristics. When maternal glucose levels are used, insulin therapy is recommended when MNT fails to maintain selfmonitored glucose at the following levels:

Fasting plasma glucose less than or equal to 105 mg/dl (5.8 mmol/l) or 1-h postprandial plasma glucose less than or equal to 155 mg/dl (8.6 mmol/l) or 2-h postprandial plasma glucose less than or equal to 130 mg/dl (7.2 mmol/l) Human insulin should be used when insulin is prescribed, and self-monitoring of blood glucose should guide the doses and timing of the insulin regimen. The use of insulin analogs has not been adequately tested in gestational diabetes mellitus.

(ADA, 2004b) Continuous glucose monitoring In the 2009 Standards of Medical Care in Diabetes, the ADA states that continuous glucose monitoring (CGM) may be a supplemental tool to SMBG in type 1 diabetes patients with hypoglycemia unawareness and/or frequent hypoglycemic episodes. CGM in conjunction with intensive insulin regimens can be a useful tool to lower A1C in selected adults (age greater than or equal to 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 Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline device (ADA, 2009).

American Association of Clinical Endocrinologists (AACE) Insulin pumps

In patients with type 1 diabetes mellitus, continuous subcutaneous insulin pump therapy is indicated for:

- Patients who are unable to achieve acceptable control using a regimen of multiple daily injections

- Patients with histories of frequent hypoglycemia and/or hypoglycemia unawareness

- Patients who are pregnant

- Patients with extreme insulin sensitivity (pump therapy facilitates better precision than subcutaneous injections)

- Patients with a history of dawn phenomenon (these patients can program a higher basal rate for the early morning hours to counteract the rise in blood glucose concentration)

- Patients who require more intensive diabetes management because of complications including neuropathy, nephropathy, and retinopathy

- Patients taking multiple daily injections who have demonstrated willingness and ability to comply with prescribed diabetes self-care behavior including frequent glucose monitoring, carbohydrate counting, and insulin adjustment (AACE, 2007).

Continuous glucose monitoring The 2007 Clinical Practice Guidelines for the Management of Diabetes state that advances in blood glucose monitoring and continuous monitoring of interstitial glucose, along with the introduction of "smart" insulin pumps, provide clinicians and patients with powerful tools to monitor and adjust treatment regimens. The guidelines recommend arranging for continuous glucose monitoring for patients with type 1 diabetes with unstable glucose control and for patients unable to achieve an acceptable HbA1c level; continuous glucose monitoring is particularly valuable in detecting both unrecognized nocturnal hypoglycemia and postprandial hyperglycemia (AACE, 2007).

European Society for Paediatric Endocrinology/Lawson Wilkins Pediatric Endocrine Society/International Society for Pediatric and Adolescent Diabetes Based on varying levels of evidence, a multisociety consensus statement made recommendations regarding the use of insulin pump therapy in pediatric age groups. Continuous subcutaneous insulin infusion (CSII) should be considered in the

conditions listed below:

1. Recurrent severe hypoglycemia

2. Wide fluctuations in blood glucose levels regardless of A1C

3. Suboptimal diabetes control (i.e., A1C exceeds target range for age)

4. Microvascular complications and/or risk factors for macrovascular complications

5. Good metabolic control but insulin regimen that compromises lifestyle

Other circumstances in which CSII may be beneficial include:

1. Young children and especially infants and neonates

2. Adolescents with eating disorders

3. Children and adolescents with a pronounced dawn phenomenon

4. Children with needle phobia

5. Pregnant adolescents, ideally preconception

6. Ketosis-prone individuals

7. Competitive athletes These recommendations are endorsed by the American Diabetes Association and the European Association for the Study of Diabetes (Phillip, 2007).

Additional product information Continuous Glucose Monitoring and Insulin Pumps for Managing Diabetes - Commercial Medical Management Guideline Accu-Chek Spirit (Disetronic), Amigo, Animas, CGMS, Dahedi (Disetronic), Dana Diabecare (Sooil), DexCom, FreeStyle Navigator, GlucoWatch G2 Biographer (no longer marketed in the U.S.), Guardian REAL-Time, MiniMed Paradigm (Medtronic), Omnipod (disposable), Paradigm REAL-Time, Ping (Animas).

Smiths Medical announced its intent to stop manufacturing and selling the Deltec Cozmo insulin pump, effective March 25, 2009. Visit the following website for additional information http://www.delteccozmoupdate.com/. Accessed March 27, 2009.

References and Resources Resources American Association of Clinical Endocrinologists (AACE). Medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007 May-Jun;13 Suppl 1:1-68.

American Diabetes Association. Standards of medical care in diabetes - 2009. Diabetes Care. 2009 Jan;32 Suppl 1:S13-61.

Available at: http://care.diabetesjournals.org/content/vol32/Supplement_1/ Accessed February 3, 2009.

American Diabetes Association. [Internet] Position Statement. Continuous subcutaneous insulin infusion. Diabetes Care 2004a;27 (suppl 1):S110. Available at: http://care.diabetesjournals.org/cgi/reprint/27/suppl_1/s110. Accessed February 6, 2009.

American Diabetes Association. Gestational diabetes mellitus. Diabetes Care. 2004b Jan;27 Suppl 1:S88-90.

Bailey TS, Zisser HC, Garg SK. Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes Technol Ther. 2007 Jun;9(3):203-10.

Bode B, Gross K, Rikalo N, Schwartz S, Wahl T, Page C, Gross T, Mastrototaro J. Alarms based on real-time sensor glucose values alert patients to hypo- and hyperglycemia: the guardian continuous monitoring system. Diabetes Technol Ther. 2004 Apr;6(2):105-13.

Buckingham B, Caswell K, Wilson DM. Real-time continuous glucose monitoring. Curr Opin Endocrinol Diabetes Obes.

2007 Aug;14(4):288-95.

Buckingham B, et al. Presentation at American Diabetes Association 67th Scientific Sessions. June 2007, Chicago.

Available:

http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=53936. Accessed February 5, 2009.

Buhling KJ, Winkel T, Wolf C, Kurzidim B, Mahmoudi M, Wohlfarth K, Wascher C, Schink T, Dudenhausen JW.

Optimal timing for postprandial glucose measurement in pregnant women with diabetes and a non-diabetic pregnant population evaluated by the Continuous Glucose Monitoring System (CGMS). J Perinat Med. 2005;33(2):125-31.

Chase HP et al.;The Diabetes Research in Children Network (DirecNet) Study Group. A randomized multicenter trial comparing the GlucoWatch Biographer with standard glucose monitoring in children with type 1 diabetes. Diabetes Care.

2005:28(5):1101-1106.

Chase HP, Roberts MD, Wightman C, Klingensmith G, Garg SK, Van Wyhe M, Desai S, Harper W, Lopatin M, Bartkowiak M, Tamada J, Eastman RC. Use of the GlucoWatch biographer in children with type 1 diabetes. Pediatrics.



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