Core CRS Response* Sample

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Core CRS Response*

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Sample

*Core CRS responses are available to all Hayes clients and are complimentary. Core responses are intended to address questions directly related to the written reports or other materials included in the client’s subscription to the Hayes Knowledge Center. The responses are focused to provide the best information that directly answers the client's questions.

Type of Client: Payer

Question: We would like some comparison information regarding standard blood

glucose monitors (those requiring testing strips and lancets) versus glucose monitors that do not require strips and lancets. What we are trying to do is

establish whether or not the new noninvasive blood glucose monitors are equally effective to the “regular” blood glucose monitors.

Response: Below is some information regarding continuous glucose monitors versus

standard blood glucose monitoring. Links to a clinical trial, online articles, and evidence-based practice guidelines are listed below. In addition, a MEDLINE literature search was conducted for studies comparing these two methods of glucose monitoring. Related Hayes Reports:

Medical Technology Directory: Continuous Glucose Monitoring Systems

Health Technology Brief: MiniMed Paradigm® Real-Time Closed-Loop Continuous Insulin Infusion and Blood Glucose Monitoring System (Medtronic MiniMed Inc.) Search & Summary: OmniPod® Insulin Management System (Insulet Corp.) for Management of Diabetes

Clinical Trials:

One related clinical trial was located. To review the details of a clinical trial, insert the study number into the search field of the form found at this site:

http://clinicaltrials.gov/ct2/search.

NCT00529815: Continuous Glucose Monitoring in Patients With Type 2 Diabetes (CGM)

Online Articles:

A randomised controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE) (Newman et al., 2009), Health Technology Assessment [Abstract #1]:

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Continuous Glucose Monitoring (2008), The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

http://diabetes.niddk.nih.gov/dm/pubs/glucosemonitor/index.htm

Practice Guidelines:

Diagnosis and management of type 2 diabetes mellitus in adults (2008), Institute for Clinical Systems Improvement (ICSI):

http://www.guideline.gov/summary/summary.aspx?doc_id=12693&nbr=006581&string=

blood+AND+glucose+AND+monitor

AACE diabetes mellitus guidelines. Microvascular complications (2007), AACE Diabetes Mellitus Clinical Practice Guidelines Task Force, Endocrinology Practice:

Clinical guideline for adults with diabetes (2006), Joslin Diabetes Center:

Diagnosis and management of diabetes mellitus. In: Laboratory medicine practice guidelines: evidence-based practice for point-of-care testing (National Academy of Clinical Biochemistry (NACB), 2006):

Literature Search: MEDLINE

Search terms: blood glucose monitorAND compare; compare monitoring patients

AND insulin AND oral hypoglycemics; self-monitoring blood glucose

AND continuous glucose monitor AND compare; glucose monitor

AND compare AND continuous glucose monitoring; noninvasive

blood glucose monitor AND compare AND type II diabetes

Search limits: English-language human clinical trials and review articles published in the past 10 years

Search yield: 23 citations Citations retrieved: 7 abstracts

1: Health Technol Assess. 2009 May;13(28):iii-iv, ix-xi, 1-194.

A randomised controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE).

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Newman SP, Cooke D, Casbard A, Walker S, Meredith S, Nunn A, Steed L, Manca A, Sculpher M, Barnard M, Kerr D, Weaver J, Ahlquist J, Hurel SJ.

University College London, London, UK.

OBJECTIVES: To evaluate whether the additional information provided by minimally invasive glucose monitors results in improved glycaemic control in people with poorly controlled insulin-requiring diabetes, and to assess the acceptability and health

economic impact of the devices. DESIGN: A four-arm randomised controlled trial was undertaken. SETTING: Participants were recruited from secondary care diabetes clinics in four hospitals in England. PARTICIPANTS: 404 people aged over 18 years with insulin-treated diabetes mellitus (types 1 or 2) for at least 6 months who were receiving two or more injections of insulin daily were eligible. Participants had to have had two glycosylated haemoglobin (HbA1c) values > or = 7.5% in the last 15 months.

INTERVENTIONS: Participants were randomised to one of four groups. Two groups received minimally invasive glucose monitoring devices [GlucoWatch Biographer or MiniMed Continuous Glucose Monitoring System (CGMS)]. These groups were compared with an attention control group (standard treatment with nurse feedback sessions at the same frequency as those in the device groups) and a standard control group (reflecting common practice in the clinical management of diabetes in the UK). MAIN OUTCOME MEASURES: Change in HbA1c from baseline to 3, 6, 12 and 18 months was the primary indicator of short- to long-term efficacy in this study. Perceived acceptability of the devices was assessed by use and a self-report questionnaire. A health economic analysis was also performed. RESULTS: At 18 months all groups demonstrated a decline in HbA1c levels from baseline. Mean percentage changes in HbA1c were -1.4 for the GlucoWatch group, -4.2 for the CGMS group, -5.1 for the attention control group and -4.9 for the standard care control group. At 18 months the relative percentage reduction in HbA1c in each of the intervention arms was less than that in the standard care control group. In the intention to treat analysis no significant differences were found between any of the groups at any of the assessment times. There was no evidence that the additional information provided by the devices resulted in any change in the number or nature of treatment recommendations offered by the nurses. The health economics analysis indicated no advantage in the groups who received the devices; a lower cost and higher benefit were found for the attention control arm. Assessment of device use and acceptability indicated a decline in use of both devices, which was most marked in the GlucoWatch group by 18 months (20% still using GlucoWatch versus 57% still using the CGMS). The GlucoWatch group reported more side effects, greater interference with daily activities and more difficulty in using the device than the CGMS group. CONCLUSIONS: Continuous glucose monitors do not lead to improved clinical outcomes and are not cost-effective for improving HbA1c in unselected individuals with poorly controlled insulin-requiring diabetes. On acceptability grounds the data suggest that the GlucoWatch will not be frequently used by individuals with diabetes because of the large number of side effects.

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Publication Types:

Randomized Controlled Trial Research Support, Non-U.S. Gov't

PMID: 19476724 [PubMed - indexed for MEDLINE] 2: Curr Diabetes Rev. 2008 Aug;4(3):200-6.

Evaluating clinical accuracy of continuous glucose monitoring devices: other methods. Wentholt IM, Hart AA, Hoekstra JB, DeVries JH.

Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands. [email protected]

With more and more continuous glucose monitoring devices entering the market, the importance of adequate accuracy assessment grows. This review discusses pros and cons of Regression Analysis and Correlation Coefficient, Relative Difference measures, Bland Altman plot, ISO criteria, combined curve fitting, and epidemiological analyses, the latter including sensitivity, specificity and positive predictive value for

hypoglycaemia. Finally, recommendations for much needed head-to-head studies are given. This paper is a revised and adapted version of How to assess and compare the accuracy of continuous glucose monitors?, Diabetes Technology and Therapeutics 2007, in press, published with permission of the editor.

Publication Types: Review

PMID: 18690901 [PubMed - indexed for MEDLINE] 3: J Diabetes Complications. 2007 May-Jun;21(3):181-6. Erratum in:

J Diabetes Complications. 2007 Jul-Aug;21(4):272. McDonald-Everett, Cindy [added]. Patterns of blood glucose monitoring in relation to glycemic control among patients with type 2 diabetes in the UK.

Secnik K, Yurgin N, Lage MJ, McDonald-Everett C.

Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN 46285, USA. AIMS: The objectives of this study were to compare patterns of blood glucose monitoring among patients with type 2 diabetes initiating therapy with insulin or oral

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medication and to examine the relationship between the quantity of prescribed monitoring strips and glycemic control. METHODS: Data were obtained from the UK General Practice Research Database. Patients were eligible if they were identified as having type 2 diabetes, initiated therapy with insulin or an oral agent, and had 12-month postinitiation data. Differences in patient characteristics and number of test strips

prescribed between the insulin (n=347) and oral cohorts (n=2436) were examined. Multivariate regressions examined the relationship between quantity of monitoring and glycemic control for a subset of patients (insulin, n=245; oral, n=1795) with available glycosylated hemoglobin (HbA1c) data. RESULTS: During the 12-month postinitiation period, patients using insulin were prescribed approximately twice as many test strips compared with those patients using oral medication (149 vs. 78, P<.0001). Multivariate regressions revealed that individuals who initiated insulin therapy and were prescribed enough test strips to test at least once per day in the 6 months prior to the HbA1c test date had, on average, a 0.65% lower HbA1c value (P=.02) compared with individuals who were prescribed fewer test strips. CONCLUSIONS: Results indicate significant differences in the prescription of blood glucose monitoring strips, with patients initiated on insulin prescribed almost twice as many test strips compared with patients initiated on orals. The greater number of blood glucose test strips prescribed was associated with lower HbA1c values for insulin patients.

Publication Types:

Research Support, Non-U.S. Gov't

PMID: 17493552 [PubMed - indexed for MEDLINE] 4: Diabetes Technol Ther. 2006 Apr;8(2):165-73.

Assessment of glycemic control after islet transplantation using the continuous glucose monitor in insulin-independent versus insulin-requiring type 1 diabetes subjects.

Paty BW, Senior PA, Lakey JR, Shapiro AM, Ryan EA.

Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. [email protected]

BACKGROUND: The aim of this study was to assess and compare glycemic control using the continuous glucose monitor (CGMS, Medtronic Minimed, Northridge, CA) in type 1 diabetes mellitus (T1DM) subjects who are insulin-independent versus those who require insulin after islet transplantation alone (ITA). METHODS: Glycemic control was assessed using 72-h CGMS in eight T1DM subjects who were insulin-independent after ITA (ITA-II), eight T1DM subjects who were C-peptide-positive but insulin-requiring after ITA (ITA-IR), and eight non-transplanted (NT) T1DM subjects. RESULTS: Standard deviation of glucose values was not significantly different between ITA-II and ITA-IR subjects (ITA-II, 1.2 +/- 0.1 mM; ITA-IR, 2.0 +/- 0.3 mM; P = 0.072). Both ITA groups

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were more stable than NT subjects (NT, 3.3 +/- 0.3 mM; P = 0.001 vs. ITA). Mean high glucose values were significantly lower in ITA subjects compared with NT subjects (ITA-II, 10.5 +/- 0.6 mM; ITA-IR, 13.0 +/- 1.0 mM; NT, 16.1 +/- 1.1 mM; P = 0.002). Mean average glucose values were not significantly different among all groups (ITA-I, 6.7 +/- 0.2 mM; ITA-IR, 7.8 +/- 0.3 mM; NT, 7.7 +/- 0.6 mM; P=0.198). Mean low glucose values were significantly higher in both ITA groups compared with NT subjects (ITA-II, 4.5 +/- 0.2 mM; ITA-IR, 4.3 +/- 0.3 mM; NT, 3.0 +/- 0.2 mM; P = 0.003). Duration of hypoglycemic excursions (<3.0 mM) was markedly reduced in both ITA groups (ITA-II, 0%; ITA-IR, 2.4 +/- 0.2%; NT, 11.8 +/- 4.2%). Glycated hemoglobin was not significantly different between ITA groups (ITA-II, 6.4 +/- 0.2%; ITA-IR, 6.5 +/- 0.3%) and was

significantly higher in NT subjects (8.3 +/- 0.2%; P < 0.001 vs. ITA). CONCLUSIONS: CGMS monitoring demonstrates that glycemic lability and hypoglycemia are significantly reduced in C-peptide-positive islet transplant recipients, whether or not supplementary, exogenous insulin is used, compared with non-transplanted T1DM subjects.

Publication Types:

Research Support, Non-U.S. Gov't

PMID: 16734547 [PubMed - indexed for MEDLINE] 5: Diabetes Technol Ther. 2006 Apr;8(2):146-55.

Evaluation of CGMS during rapid blood glucose changes in patients with type 1 diabetes.

Wilhelm B, Forst S, Weber MM, Larbig M, Pfützner A, Forst T.

Institute for Clinical Research and Development, Johannes Gutenberg University, Mainz, Germany.

BACKGROUND: CGMS (Medtronic Minimed, Duesseldorf, Germany) allows continuous glucose monitoring. Recent studies with invasive monitoring techniques revealed

discrepancies in blood glucose measurements obtained from different anatomical sites compared with those from the fingertip. The aim of this study was to investigate the CGMS and a device for alternative site testing (AST) during dynamic blood glucose changes and to compare these results with fingertip measurements. METHODS: Twelve patients with type 1 diabetes (seven women, five men; age, 33.3 +/- 8.7 years) received a 75-g oral glucose load. Insulin was applied intravenously (rapid glucose decline) or subcutaneously (moderate glucose decline) in a dosage between 3 to 18 units 2 h later in a randomized sequence on two different days. For continuous glucose measurements the CGMS standard sensor was inserted into the lower abdominal subcutis. Glucose measurements were obtained from the forearm using a minimally invasive technique (AST). CGMS and AST measurements were compared with glucose measurements obtained from the fingertip using a standard glucose oxidase method.

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RESULTS: No significant difference could be observed among all three methods during increasing glucose levels. Insulin-induced blood glucose decline resulted in a significant time lag in the time course of blood glucose measurements obtained by AST compared with those obtained from the fingertip (P < 0.05, respectively). No significant difference could be observed between CGMS and fingertip measurements. Error grid analysis revealed 100% during rapid glucose fall and 98.5% during modest glucose fall of CGMS measurements within the clinically acceptable zones A and B. CONCLUSIONS:

Continuous glucose measurements using CGMS provide reliable glucose measurements even in the case of dynamic blood glucose changes. Publication Types:

Comparative Study

PMID: 16734545 [PubMed - indexed for MEDLINE] 6: Exp Clin Endocrinol Diabetes. 2005 Oct;113(9):541-4.

InDuo, a novel combined insulin injection and blood glucose monitoring device - effective and save as other devices, and patient preference.

Haupt A, Berg B, Paschen P, Dreyer M, Häring HU, Smedegaard J, Skovlund SE, Matthaei S.

Medizinische Klinik IV, Uniklinikum Tuebingen, Germany. [email protected]

BACKGROUND AND AIM: Frequent blood glucose (BG) monitoring and insulin administration are necessary in intensive insulin regimes. A new integrated system, InDuo is a compact and portable combined insulin doser and BG monitor, designed to overcome some of the limitations of current insulin therapy. The aim of the study was to compare InDuo and a non-integrated system (HumaPen Ergo and Accu-Chek Sensor Meter) for efficacy and safety, and to evaluate patients preference. MATERIALS AND METHODS: The trial design was a multicentre, randomised, 12-week, open-label, comparative, two period crossover. One hundred and ten patients with diabetes, treated with a basal bolus regime, were included. The subjects were assigned to use either InDuo or the non-integrated system. After six weeks of treatment, the subjects were transferred to the alternative system. To assess efficacy, fasting plasma glucose (FBG), 7-point blood glucose profile, serum fructosamine and HbA1c were measured. Serum fructosamine and FBG were measured at baseline and at six and 12 weeks; HbA1c was measured at baseline and week 12. Safety endpoints were number and severity of hypoglycaemic episodes, adverse events and adverse device effects. Patient preference was assessed by a comparative device questionnaire at 12 weeks. RESULTS: Analysis with an ANOVA mixed model showed no difference after each treatment between serum fructosamine or between FBG levels. HbA1c decreased

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during the trial from 7.5 % +/- 1.2 to 7.1 % +/- 0.8 at 12 weeks. The safety profiles were similar for both treatments for hypoglycaemic episodes. The incidence of adverse events was also similar. There were 10 adverse device effects reported: eight for the Innovo device in the InDuo, one for the InDuo device and one for the Accu-Chek Sensor Meter. The comparative device questionnaire at 12 weeks showed patients strongly preferred InDuo to HumaPen Ergo and Accu-Chek Sensor Meter (all p < 0.0001). Of those preferring InDuo, more than 60 % classified their choice as very or extremely strong. Both memory functions in InDuo(R) (i. e., for insulin dosage and for blood glucose readings) were used by more than 70 % of the patients. CONCLUSION: Treatment with the InDuo system was as effective and safe as treatment with the non-integrated system. Almost 75 % preferred using InDuo to the non-non-integrated HumanPen Ergo and Accu-Chek Sensor Meter.

Publication Types: Comparative Study Multicenter Study

Randomized Controlled Trial

PMID: 16235158 [PubMed - indexed for MEDLINE] 7: J Clin Pharm Ther. 2004 Jun;29(3):273-7.

Glucose self-monitoring in primary care: a survey of current practice.

Stewart D, McCaig D, Davie A, Juroszek L, Blackwood L, Findlay N, McCarthy S. School of Pharmacy, The Robert Gordon University, Aberdeen AB10 1GG, Scotland, UK. [email protected]

BACKGROUND: The role of long-term glycaemic control in minimizing long-term complications of diabetes mellitus is evidence-based and national guidelines

recommend a target glycosylated haemoglobin level of approximately 7%. Although the role of self-monitoring blood and urine glucose is less well defined, this activity

consumes vast National Health Service (NHS) resources. AIMS: The aims of this study were to (i) determine the current practice of glucose self-monitoring in primary care, (ii) determine any changes to therapy made as a result and (iii) compare monitoring and frequency of monitoring in those patients using insulin with those patients taking oral hypoglycaemic agents. METHODS: Postal questionnaire to 311 patients using insulin or oral hypoglycaemic agents identified from three general practices. RESULTS: The response rate was 59.8% (186/311), with the majority of responding patients (n = 158, 87.3%) performing self-monitoring. The patients using insulin were more likely to be self-monitoring than those taking oral therapy (chi(2), P < 0.001, d.f. = 1). The majority of patients who self-monitored and were using insulin (n = 45, 61.1%) altered the dose of insulin if a reading was beyond their target range. However, the majority of patients

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who self-monitored and were taking oral therapy (n = 48, 68.6%) took no action at all. CONCLUSIONS: Blood glucose self-monitoring was common in those treated with insulin or oral hypoglycaemics, although those using insulin were more likely to self-monitor. Notably many patients, particularly those on oral therapy, took no action based on the results of self-monitoring.

Publication Types: Comparative Study