PRE -ASSESSMENT Diabetic Testing
Before CCOHTA decides to undertake a health technology assessment, a pre-assessment of the literature is performed. Pre-assessments are based on a limited literature search; they are not CCOHTA extensive, systematic reviews of the literature. They are provided here as a quick guide to important, No. 34 current assessment information on this topic. Readers are cautioned that the pre-assessments have May 2004 not been externally peer reviewed.
Introduction Diabetes is prevalent in 5% of the Canadian population.1 Type 2 non-insulin dependent diabetes mellitus (NIDDM) accounts for 85% to 90% of patients with diabetes mellitus. Patients with diabetes have an increased risk for developing complications from cardiovascular (i.e., heart, cerebrovascular and peripheral vascular) disease including neuropathy (leading to limb amputation), retinopathy (leading to blindness) and nephropathy (leading to dialysis and transplant).
The clinical management of diabetes ranges from surveillance and primary prevention (preventing disease occurrence) to secondary prevention and management of complications. Regular treatment and the measurement of blood lipid parameters, blood pressure and glycemia used to modify treatment plans are encouraged in patients with type 1 (insulin-dependent) or type 2 diabetes (Figure 1).1
Figure 1: Diagnosis and care of diabetes based on glycemic control
Management of Diabetes TreatingTreating: 1. What is the evidence that LifestyleEducation –about physical improved glycemic control nutritional,lifestyle, nutrition and and delays or leads to fewer disease knowledge complications education Diagnosis and and screening screening AntihyperglycemicAntihyperglycemic medications medications Glycemic Complications Type 1 control Type 1 or death or typetype 2 2 diabetes diabetes
Testing:Testing
GlucoseFasting in bloodplasma or plasmaglucose
Fructosamine 2. What is the evidence that testing leads to HbA 1c improved glycemic control?
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Tests for glycemia are supposed to help patients maintain glycemic control. These tests include fasting blood and plasma glucose measurements, glycosylated hemoglobin measurements (HbA1c) and fructosamine measurements. Traditionally, HbA1c tests are done in a laboratory and blood glucose tests at home. Point-of-care and home-based tests have been developed for HbA1c and fructosamine testing.
At issue is the scientific evidence supporting glucose testing in diabetes. The necessary minimum condition for any test is that its output may cause a change in a patient’s clinical management. The test results must also decrease the probability of disease once a new treatment plan is chosen.2
Research Questions Based on the current recommendations for the diagnosis and management of diabetes:
1) What is the scientific evidence that tests of glycemia lead to reduced or delayed complications in patients diagnosed with type 1 or type 2 diabetes? If there is evidence that testing of glycemia leads to reduced or delayed complications, what is the optimal frequency of testing?
2 a) What is the scientific evidence that testing leads to improved glycemic control? In particular, what is the evidence that self-monitoring of blood glucose (SMBG), point-of-care or self-monitoring of glycosylated hemoglobin or fructosamine monitoring in any setting will lead to better glycemic control?
b) If there is evidence that testing leads to improved glycemic control, what is the optimal frequency?
c) What is the evidence that testing results are used to modify lifestyle and medication therapy for persons with diabetes?
3) What is the evidence that improving glycemic control leads to reduced or delayed complications in individuals diagnosed with type 1 or type 2 diabetes?
Assessment Process Literature was identified by searching MEDLINE® via PubMed (1966-11 Aug 2003), The Cochrane Library (2003 Issue 3), web sites, clinical practice guidelines and clinical trial registries, according to the Canadian Coordinating Office for Health Technology Assessment’s (HTA) checklist.
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Summary of Findings Approximately 1,500 citations were captured during the electronic search. Citations describing research that focuses on the relevant clinical questions are listed in Tables 1 and 2. Trials and observational studies were captured in this preliminary search.
Research question 1) What is the evidence that testing leads to reduced or delayed complications or death for individuals diagnosed with type 1 or type 2 diabetes?
Response to question 1) None of the randomized controlled trials identified compared testing versus no testing and assessed its impact on complications or death.
Research question 2 a) What is the evidence that testing leads to improved glycemic control? In particular, what is the evidence that SMBG, point-of-care or self-monitoring of glycosylated hemoglobin or fructosamine monitoring in any setting will lead to better glycemic control?
Response to question 2 a) Several reviews, including two systematic reviews of the evidence from RCTs, were found (Table 1). The authors of one systematic review3 conducted a meta-analysis. In children or adult type 1 diabetics, blood glucose monitoring led to a detectable difference in glycosylated hemoglobin (mean difference 0.57%, 95%CI: 1.073 to 0.061) when compared to urine monitoring. On the contrary, no difference between SMBG and urine glucose was detectable from studies involving type 2 diabetics. Further to this, a significant effect on glycemic control from self-monitoring could not be detected.
For type 1, we identified one new RCT and eight previously identified RCTs. Three interrupted time-series, five prospective cohort studies, nine retrospective or cross- sectional studies and three surveys were also identified (Table 2).
For type 2, two new RCTs were identified (one ongoing), with eight RCTs that were previously identified. Two non-randomized studies, one interrupted time series, two prospective cohort studies, 11 retrospective or cross-sectional cohort studies and four surveys were identified (Table 3).
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Table 1: Reviews identified for question 2 a)
Citation Type of Report (if known) Conclusions (if known) Coster, Gulliford, et al. Systematic review 20003 conducted for NCCHTA/NICE Grimaldi & Sachon Review Prospective randomized studies are needed 20034 to confirm efficiency of SMBG in type 2 diabetes Goldstein, Little, et al. Review and guidance 20035 Court 20026 Unknown Kennedy 20017 Review Unknown Norris, Engelgau, et al. Systematic review of training 20018 (which might include SMBG) Hom 19999 Review Unknown Rindone 199810 Unclear whether this is a review Halimi 199811 Review Use of SMBG is increasingly recommended by diabetologists and general practitioners, but trials investigating effects of SMBG in NIDDM patients found no benefit for metabolic control or weight loss; we recommend a moderate use of SMBG in NIDDM patients Faas, Schellevis, et al. Efficacy of SMBG in NIDDM patients is 199712 questionable and should be tested in rigorous high-quality RCT, for which some recommendations are given Goldstein, Little, et al. Review Unknown 199513 Goldstein 199414 Review Unknown Patrick, Gill, et al. Commentary 199415 Wysocki 198916 Review
Blohme 198317 Review
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SMBG in type 1 diabetes: Our search revealed one new RCT. Most of the studies identified were cross-sectional cohort studies or surveys. One identified RCT evaluated continuous glucose monitoring as an addition to standard monitoring. Several prospective cohorts were identified; two suggested SMBG can lead to tighter glycemic control (Table 2).
Table 2: Studies of SMBG in type 1 diabetes
Citation Design and Patient Group Results
Ludvigsson & Hanas RCT of children (n=27) to HbA1c decreased in unmasked arm 200318 continued glucose monitoring (7.70% to 7.31%) after 3 months but not in blind arm (7.75% to 7.65%) Adams, Mah, et al. Cross-sectional cohort study of Lower rates of SMBG associated with 19 2003 adults (n=4,565) lower HbA1c testing frequency and higher HbA1c levels in insulin-dependent Otieno, Ng'ang'a, et Cross-sectional study (n=?) in Morning random blood glucose within al. 200220 Kenyan ambulatory clinic usual therapeutic targets of 4 mmol/L to 8 mmol/L predicted good glycemic control (HbA1c≤7.8%) with high sensitivity at the range of 86.3% to 98.4% Rotchford & Cross-sectional retrospective Blood glucose monitoring not regularly Rotchford 200221 design (n=253) in South Africa performed and medications rarely modified, mean HbA1c 11.3% Salardi, Zucchini, et Retrospective cohort (n=28) of CGM correlates with HbA1c (r=0.53, al. 200222 CGM users p=0.002) and decreased during OL cohort study Soumerai, Mah, et Quasi-experimental pre-post No discernible effect of policy change al. 200223 interrupted time-series design among insulin-treated patients assessing trends two years before and after policy decision to cover Clua Espuny, Puig, Cost-effectiveness analysis Use of SMBG not cost-effective et al. 200024 Deckers, Hermans, Adult cohort (n=465) cross- Median HbA1c was 8.5% (7.7% to 9.3%); et al. 200125 section all practised monitoring Karter, Ackerson, et Survey of 1,160 diabetics 395 Frequency of self-monitoring correlated 26 al. 2001 SMBG at least three times daily with decreases in HbA1c overall Levine, Anderson, et Prospective cohort of youths (7 to Blood glucose monitoring frequency was 27 al. 2001 16 years old, n=300) in special sole modifiable predictor of HbA1c care (p<0.0001) Kovatchev, Cox, et Unknown Unknown al. 200028 Orozco, Laparra, et Unknown Unknown al. 199929 Evans, Newton, et Diabetes database: type 1 Correlation between reagent strip uptake al. 199930 (n=807) and glycemic control for 258 patients; 0.7% decrease for every 180 strips used Cava, Cantos, et al. Quasi-experimental pre-post Mean glycemic values reduced 199931 assessment of type 1 (n=13) and compared to previous year type 2 (n=72) diabetics
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Table 2 cont’d…
Strowig & Raskin Pre-post assessment of intensely Mean GHb level averaged across all 199832 treated type 1 diabetics (n=22) patients during period of memory meter using SMBG with storage versus use (6.4%) significantly lower than that those without during period of meter use without memory (6.9%) (p=0.0004) Weitgasser, Schnoll, 5-year cohort of type 1 (n=57) Frequency of blood glucose 33 et al. 1998 diabetics measurements increased; HbA1c decreased from 7.3±1.2 to 6.4±1.1% after 5 years (p<0.001). Buysschaert, Maes, Retrospective cohort (n=1,200) HbA1C also below 8% (controlled) in 50% et al. 199734 of patients using 1,100 to 1,200 strips per year Nathan, McKitrick, et Retrospective pre-post study Increased frequency of self-monitoring al. 199635 based on chart review (type 1 and of insulin injections associated with n=94 and type 2 n=137) lower HbA1c in IDDM Tulokas 199536 Unknown Unknown Ikeda & Tsuruoka Unknown Results of this study of SMBG revealed 199437 that it was useful for prevention of chronic complications and for education of diabetes patients Starostina 1994 RCT (not truly random): urine Information not available (identified from (n=61) versus blood (n=60) systematic review3) versus control (n=60) Ziegher, Kolopp, et Pre-post cohort (n=80) type 1 Fifty-nine patients (79%) were compliant al. 199338 with SMBG and had better metabolic control than non-compliers (HbA1c: 6.7±1.1% versus 7.5±1.9, p<0.05) Brinchmann- Prospective cohort with follow-up Intensified insulin treatment and home Hansen, Dahl- for seven years blood glucose monitoring improved Jorgensen, et al. concentrations of glycated hemoglobin 39 1992 (HbA1) from 11.2% (2.2%) at start of study to mean of 9.5% (1.5%) over seven years of study (p<0.0001) Gordon, Semple, et RCT with crossover (n=25); trial No correlation between frequency at al. 199140 arms were four-point profiles on 2 which patients altered insulin doses and days per week; four-point profiles measures of metabolic control. Altering on 1 day per week; two-point frequency of SMBG had variable and profiles on every day of week uncertain influence on frequency at which patients altered insulin doses Newman, Laqua, et Retrospective cohort of diabetic SMBG levels alone did not improve al. 199041 patients (n=21) who self- mean amount of glycemia in these monitored glucose levels (via patients reflectance meter or visual strips) were compared with 17 closely matched patients Larsen, Petersen, et Prospective cohort of diabetics Home blood glucose monitoring did not al. 199042 (n=120) evaluated by physicians lead to better agreement between without HbA1c measurement classifications
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Table 2 cont’d…
Lam, Ma, et al. Chinese type 1 (n=38) cohort After long-term SMBG, 82% of patients 43 1986 divided into poor control (n=27) in group B had good control (HbA1≤10%) and regular (n=11) groups compared with 45% in group A (p<0.05) Lombrail, Obadia, et Survey of type 1 diabetics Mean HbA1 at time of visit was not al. 198644 (n=282) who routinely visited statistically different in patients clinic performing home blood glucose testing only (9.3±2.1%), in patients monitoring blood and urine (9.2±2%) or urine only (9.3±1.7%) and in patients who did not practise self-monitoring (9.5±1.8%) Daneman, Siminerio, Double crossover study (n=16) of No significant differences could be et al. 198545 children to urine plus SMBG or detected between two groups at any urine alone stage of study Terent, Hagfall, et al. RCT, 18 months, (n=37) Education did not improve mean HbA1 198546 randomized to individual formal values; final HbA1 level, however, did education followed by SMBG not differ significantly between groups (n=10), instruction in SMBG without pre-education (n=8), only formal education (n=9) and a reference group (n=10) Mann, Noronha, et CT, 18 months, children receiving HbA1c levels showed seasonal al. 198447 intensive education (N=20) or fluctuation, but values at beginning and education combined with SMBG end of study nearly identical to each (N=19) other in both groups; SMBG group showed a reduction in number of hospital admissions for stabilization of control and for ketoacidosis (p<0.04) Carney 1983 Cluster randomized trial (n=86) to Absolute difference in glycated (identified from blood versus urine monitoring hemoglobin -0.72 (95% CI -1.40 to 0.04) systematic review3) Miller 1983 RCT (n=19) Absolute difference in glycated (identified from hemoglobin -0.40 (95% CI -3.95 to 3.15) systematic review3) Schiffrin & Belmonte Crossover RCT? In compliant, motivated young adults 198248 with insulin-dependent diabetes, frequent self-glucose monitoring is critical for long-term maintenance of glycemic control Worth 1982 RCT crossover (n=38) of urine Information not available (identified from monitoring versus SMBG (visual) systematic review3) or SMBG (meter) for 60 weeks Walford, Gale, et al. Cohort (n=67) of type 1 diabetics Patients found self-monitoring more 197849 informative than urine tests; their involvement in management of disease resulted in better motivation OL=open label; B=blinded; RCT=randomized controlled trial; CGM=continuous glucose monitoring; CT=controlled trial; GHb=glycosylated hemoglobin
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SMBG in type 2 diabetes: One new RCT was identified. Its results suggest that SMBG used six times during a day, on two days per week, can have a greater impact than no monitoring in type 2 diabetics who do not require insulin. An intention-to-treat analysis was not done. Retrospective cohort studies have produced mixed results: some have suggested increased testing frequency leads to better glycemic control, while some have suggested the opposite. One retrospective cohort suggested that there was no correlation between glycemic control and SMBG type 2 diabetics who take insulin (Table 3).
Table 3: SMBG in type 2 diabetes
Citation Design Highlighted Conclusions 50 Farmer 2002 (in RCT to determine effect of SMBG Main outcome is HbA1c with additional progress) in people with type 2 diabetes; measurements of risk factors for patients trained to use SMBG cardiovascular disease, satisfaction with care, quality of life and costs of care. Structured interviews to be conducted to identify those most likely to benefit Hoffman, Shah, et Stable, insulin-treated subjects Twice-daily testing strategies, particularly al. 200251 (n=150, age=67) SMBG using pre-lunch and pre-dinner, assess glycemic different strategies, cohort study control and capture proportion of out-of- range readings Ozmen & Boyvada Cohort of patients without In group without diabetic retinopathy at 6- 52 2003 retinopathy (n=140, 52.4%), and 12-month controls, mean HbA(lc) background retinopathy (n=75, concentration <7%, but in group with 28.1%) or proliferative retinopathy diabetic (background and proliferative) (n=52, 19.5%) taught to use retinopathy, value could not be reduced SMBG below 7% Adams, Mah, et al. Cross-sectional study (n=4,565), Higher HbA1c test frequency associated 200319 adults with more monitoring in oral agents Ingleby, Cohort study Information not available Trowbrudge, et al. 200253 Meier, Swislocki, et Retrospective cohort study Similar findings observed in cohort of 421 54 al. 2002 drug-treated patients with paired HbA1c data before and after (policy decision to decrease SMBG to twice weekly) Schwedes, Siebolds, Multi-site RCT (n=250) comparing HbA1c decreased more in SMBG group et al. 200255 SMBG 6 times/day 2 times per (1.0% (1.08) versus 0.54 (1.41), p=0.0086) week versus no SMBG; individuals not on insulin Soumerai, Mah, et Quasi-experimental pre-post Among 288 patients who initiated SMBG, 23 al. 2002 interrupted time-series design HbA1c reduced from 10.8% to 8.6% and assessing trends two years frequency rose 34% before and after policy decision to cover
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Table 3 cont’d…
Blonde, Ginsberg, et Unknown Unknown al. 200256 Harris, 200157 Cross-sectional survey from Frequency of self-monitoring correlated NHANES with increases in HbA1c overall Karter, Ackerson, et Survey of 23,412 diabetics; 7,500 Frequency of self-monitoring correlated 26 al. 2001 SMBG at least once daily with with decreases in HbA1c overall retrospective cohort analysis Franciosi, Pellegrini, Survey of 3,567 with retrospective SMBG associated with higher levels of 58 et al. 2001 cohort analysis HbA1c in patients not treated with insulin Lerman-Garber, Longitudinal cohort study (n=60) A bimonthly fasting PG correlated well Lopez-Ponce, et al. with the HbA1c and is easiest and 200159 cheapest way of monitoring glycemic control in type 2 diabetic patients with some preserved insulin reserve (diabetes for <10 years and on treatment with one hypoglycemic agent) Evans, Newton, et Retrospective cohort type 2 study No correlation between reagent strip al. 199930 (n=790) uptake and glycemic control for 290 patients with type 2 diabetes who used insulin Clua Espuny, Puig, Retrospective cohort type 2 study 41.06% of diabetics practised MBG on et al. 199960 (n=597) stable basis, without significant differences showing in either HbA1c percentage, in any of biological variables defining metabolic control in relation to practice or otherwise of MBG or in its frequency Schiel, Muller, et al. Cross-sectional study followed by Negative correlation (r=-0.17, p<0.001) 199961 pre-post cohort study of SMBG between frequency of blood-glucose plus training self-tests/week and HbA1c; after training, daily SMBG statistically associated with better quality of metabolic control Brewer, Chase, et al. HbA1c values compared with Strong correlation (P=0.001) found 62 1998 SMBG measurements in subjects between HbA1c values and average who did at least three blood blood glucose; and with percentage of glucose tests per day over 30 HBG measurements within, above and days in three age groups: 5 to 11, below target range in each of three age 12 to 16 and 17 to 35 years (type groups (p<0.001) 1 diabetes) Clua Espuny, Crossover, observational study Direct dispensing of reactive strips led to Queralt Tomas, et al. (n=400) important annual increase in cost 199863 (+46.59%) and consumption (+89.25%), but acceptable effectiveness not demonstrated (1.10%) Miles, 1997 RCT SMBG versus urine No difference (identified from monitoring systematic review3)
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Table 3 cont’d…
Oki, Flora, et al. Survey (n=98) GHb comparable between testers and 199764 non-testers; among testers, no difference in mean GHb values based on frequency of SMBG Gallichan 1994 RCT SMBG versus urine No difference (identified from monitoring systematic review3) Muchmore, Springer, RCT; 23 overweight (body mass HbA1c level showed progressive decline et al. 199465 index 27.5 to 44 kg/m2) patients in experimental subjects (p<0.05), aged 40 to 75 participated in 28- whereas there was no improvement in week behavioral weight control control subjects program Klein, Oboler, et al. Cross-sectional cohort study Home glucose monitoring, particularly of 199366 (n=200) urine, widely practised; convincing evidence of its value in helping patients improve their blood glucose control or preventing complications of disease is lacking Allen, DeLong, et al. RCT (n=54) patients randomized Both urine-testing and SMBG groups 199067 to SMBG or urine testing showed similar improvement in glycemic control; in each group, there were significant improvements in fasting plasma glucose (reduction of 1.4±3.2 mM, P<0.03) and glycosylated hemoglobin (reduction of 2.0±3.4%, p<0.01) levels Larsen, Petersen, et Retrospective cohort of diabetics Home blood glucose monitoring did not al. 199042 (n=120) evaluated by physicians lead to better agreement between without HbA1c measurement classifications of poor, moderate and good glycemic control Rutten 1990 RCT with SMBG versus Glycated hemoglobin decrease in (identified from conventional care intervention group; increase in control systematic review3) group Estey 1989 RCT of telephone calls and home No difference (identified from visits leading to greater SMBG systematic review3)
Fontbonne, Billault, RCT. Poorly controlled diabetic At end of study period, decrease of 68 et al. 1989 patients (n=208) were HbA1c over six months (main end point) randomized to group A, regular was not significantly different among HbA1c determinations but no self- three groups (mean±SEM: group A monitoring; group B, self-urine -0.5±0.2%, group B -0.1±0.3%, group C glucose monitoring, twice every -0.4±0.3%) other day; group C, SMBG twice every other day; and followed six months
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Table 3 cont’d…
Mercelina, Cross-sectional cohort study Fasting blood glucose and serum Degenaar, et al. (n=98) fructosamine values cannot replace 69 1989 HbAlc measurement for monitoring diabetic control Wing, Epstein, et al. RCT of obese patients with type No evidence that addition of SMBG 198670 II diabetes (n=50) assigned either levels to treatment program improved to standard behavioral weight outcome in terms of weight loss, control program or to weight reduction in medication, dietary control program that included compliance or mood state SMBG levels and focused on weight to blood glucose relationship. Wing, Lamparski, et Retrospective cohort study Data suggest that frequency and al. 198571 (n=282) accuracy of SMBG are independent and that neither ensures good glycemic control Worth, Home, et al. RCT crossover study (n=38) Despite patients’ enthusiasm and other 198272 reports to contrary, home blood glucose monitoring offered no improvement in control over intensive attention and conventional urine glucose monitoring PG=plasma glucose
Home or point-of-care glycosylated hemoglobin testing
Types 1 and 2 diabetes: One identified RCT and one prospective cohort study further supported the importance of knowing an HbA1c result. One rapid point-of-care test (called “DCA 2000”) was able to produce 82% of results within a “clinically acceptable” error range, suggesting that laboratory testing might be of more value. Two retrospective and cross-sectional cohort studies and one survey were also identified (Table 4).
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Table 4: Studies of home or point-of-care glycosylated hemoglobin testing (type 1 or 2 diabetes)
Citation Design Highlighted Conclusions Rector, Venus, et al. Survey of 380 members of a 55% did not use the kit 73 2001 health plan given a POC HbA1c kit Parkes, Ray, et al. B-D A1c At-Home test kit was B-D A1c At-Home results, which are 199974 evaluated in a clinical trial using highly correlated with the standard 1,625 dried blood spot samples Cobas Integra Hemoglobin A1c assay, from 59 subjects diagnosed with (r2=94.7%), demonstrate excellent type 1 or type 2 diabetes within-subject reproducibility for 3- to 10- collected in an in-clinic setting day-old samples (coefficient of variation =2.7%) and provide a coefficient of variation =3.9%for among-subjects Le Marois, Bruzzo, Retrospective blood sample study Of glycemic levels calculated from DCA et al. 199675 (n=103) values using this formula, 82% fell within a clinically acceptable error range when compared with measured glycemic values Larsen, Horder, et RCT of 240 patients with IDDM: Among 222 patients still being followed 76 al. 1990 one group of patients and after one year, mean HbA1c value clinicians knew HbA1c, the other decreased significantly from 10.1% to did not 9.5% (p<0.005) in group whose HbA1c level was monitored (n=115), whereas initial and one-year values in control group (n=107) were 10.0% and 10.1% respectively. Patients in group whose HbA1c level was monitored were seen and their insulin regimens changed more often, but they were hospitalized for acute care of their diabetes less often than those in control group. A similar decrease in HbA1c values occurred in control group in following year, when their caregivers knew their HbA1c values Larsen, Petersen, et Cohort of diabetics (n=120) Identity between classifications was al. 199042 evaluated by physicians without seen in 52%, but 30% of diabetics were HbA1c measurement considered in good or acceptable control despite HbA1c values >10.0% Lenzi, Giampietro, et Longitudinal cohort (n=234, for However, we found that one of every al. 198777 two years) in type 1 (n=139) and three well-controlled patients (both type I type 2 (n=95) and II subjects) had high values for HbA1
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Fructosamine testing
Three RCTs were identified. Two prospective cohort studies and five retrospective studies were also identified.78-80 Little of the available evidence suggested an advantage to using fructosamine testing. One RCT showed that glucose testing was better than fructosamine testing after six months. Several retrospective cohorts suggested that it was poorly predictive of glycemic control. One survey suggested physicians thought that fructosamine measurements were helpful (Table 5).
Table 5: Fructosamine testing
Citation Design Highlighted Conclusions
Chen, Chen, et al. Longitudinal time-series cohort HbA1c measurement correlates more 200281 (n=25) of type 2 diabetics significantly with home capillary blood glucose levels than fructosamine assay, even over previous 2 to 3 weeks Lindsey, Carter, et Interim results of RCT (n=60+) No statistical difference at 3 months al. 200282 randomly assigned to collect (p=0.676) in A1C values for group 1 weekly fructosamine in addition to (7.921%±1.848% versus 7.755%±1.408%) daily glucose (group 1) or usual and group 2 (7.800%±1.505% versus care of daily glucose (group 2) 7.971%±1.797%) were noted when compared with baseline Edelman, Bell, et al. RCT (n=25) Two groups: Study results after 3 months showed that 83 2001 glucose-only testing group (14 HbA1c values in combined glucose plus patients with an initial mean fructosamine testing group decreased from HbA1c of 9.4±0.9%) and a 9.2±0.7% to 8.0±0.5% (p<0.0001). In combined glucose plus contrast, HbA1c values in glucose-only fructosamine testing group (11 testing group declined from 9.4%±0.9% to patients with an initial mean 9.1%±1.3%, a difference that was not HbA1c of 9.2±0.7%) significant. Petitti, Contreras, et RCT (n=140) adults (HbA1c>8%) No significant difference was found between al. 200184 randomized to fructosamine or two groups in mean absolute decrease of glucose monitoring HbA1c levels at 3 months (0.5% in fructosamine group versus 0.8% in control group; P>0.2), and difference favoured control group at 6 months (0.7% fructosamine versus 1.2% control; p=0.04). Narbonne, Renacco, Retrospective blood sample study Risk of misclassification was around 10% et al. 200185 of diabetics (n=76) and healthy when fructosamine was used to estimate (n=30) subjects HbA1c. These results were unchanged when fructosamine was corrected by plasma protein level.
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Table 5 cont’d…
Austin, Wheaton, et Retrospective cohort comparing Availability of same-day fructosamine results al. 199986 fructosamine plus standard tests did not improve diabetes control compared versus standard tests and survey with that obtained using only fasting serum of physicians glucose values and prior HbA1c concentrations. Most examining physicians stated that same-day fructosamine concentrations helped them significantly with diabetes management Cefalu, Wang, et al. Cross-sectional (n-=51) and Fingerstick fructosamine was shown to 199987 prospective cohort (n=20, type 2 correlate highly to laboratory fructosamine diabetes) studies (r=0.80, p<0.001) and glycated hemoglobin (r=0.81, p<0.001). Kruseman, Retrospective blood sample study Despite significant correlation, predictive Mercelina, et al. (n=98) values of parameters studied for acceptable 88 1992 HbA1c value seemed to be low (37% and 44% respectively) Gebhart, Wheaton, Retrospective cohort (n=17) study Of three types of glycated protein assays, et al. 199189 fructosamine, with its advantage of speed and simplicity, may offer a more cost- effective alternative Lim, Jhoo, et al. Retrospective blood sample study Fructosamine concentration had significant 198990 comparing normal (n=50) and correlation to fasting plasma glucose NIDDM (n=36) patients determined 2 weeks before (r=0.72, p<0.002) Mercelina, Duplicate of Kruseman et al. Despite significant correlation, predictive Degenaar, et al. study values of parameters studied for acceptable 69 1989 HbA1c value seemed to be low (37% and 44% respectively) POC=point of care
Research question 2 b) If there is evidence that testing leads to improved glycemic control, what is the optimal frequency?
Response to question 2 b) In type 1 diabetes, where there is evidence to support the assertion that testing leads to glycemic control, two reports (one RCT40 and one interrupted time-series23) were identified. Neither report concludes testing frequency (below two strips a day) has a discernible impact on glycemic control (Table 6).
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Table 6: Studies of optimal frequency for SMBG
Citation Design Highlighted Conclusions Gordon, Semple, et RCT with crossover (n=25): trial No correlation between frequency at which al. 199140 arms were four-point profiles on 2 patients altered insulin doses and measures days per week; four-point profiles of metabolic control. Altering frequency of on 1 day per week; two-point SMBG had variable and uncertain influence profiles on every day of week on frequency at which patients altered insulin doses Soumerai, Mah, et Quasi-experimental pre-post No discernible effect of policy change among al. 200223 interrupted time-series design insulin-treated patients assessing trends two years before and after policy decision to cover
Research question 2 c) What is the evidence that testing results are used to modify lifestyle and medication therapy for persons with diabetes?
Response to question 2 c) No trial was identified that examined the influence of testing on modifying behaviour. An abundance of research exists (including one systematic review) to describe the influence of educational strategies on modifying behaviour.
Research question 3) What is the evidence that improving glycemic control leads to reduced or delayed complications in individuals diagnosed with type 1 or type 2 diabetes?
Response to question 3) Type 1 diabetes: Evidence from two randomized controlled trials (RCTs)91,92 including one involving >1,400 patients followed for 6.5 years shows that the development and progression of retinopathy, nephropathy and neuropathy can be delayed by more intensive therapy tailored to target HbA1c and blood glucose goals. Further supportive evidence was available from three longitudinal cohort studies and a cross-sectional survey (Table 7).
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Table 7: Studies of the effect of glycemic control on reductions in mortality and morbidity in type 1 diabetes
Author(s), Year Design Results Kawano, Omori, et Cross-sectional survey Prevalence of diabetic neuropathy as al. 200193 (n=6,472) determined by attending physician increased with disease duration and worse control of diabetes. Study found that most diabetics suffered from neurological symptoms, although half of such symptoms were not considered to be those of diabetic neuropathy by physicians Kullberg & Longitudinal cohort of adults Patients without retinopathy had a mean 94 Arnqvist 1995 diagnosed before 31 and with a HbA1c±SEM for the whole follow-up period duration of diabetes of >20 of 6.3±0.19%; the 117 patients with years, follow-up 9.4 years background retinopathy but not macula edema, 7.0±0.08 Kullberg, Longitudinal cohort of adults Patients with mean HbA1c>8% had higher Finnstrom, et al. diagnosed before 31 and with a relative risks for background retinopathy, 95 1994 duration of diabetes of <25 compared with patients having HbA1c≤7% years, follow-up 9.2 years The Diabetes MC unblinded RCT type 1 76% RRR (62% to 85%) in retinopathy; Control and diabetics with no retinopathy 26% RRR (8% to 50%) in macular edema; Complications (n=726) or mild retinopathy 60% RRR (38% to 74%) in neuropathy Trial (DCCT) (n=715) randomized to intensive Research Group or conservative therapy for 6.5 199391 years Brinchmann- Longitudinal cohort study with Mean value for HbA1>10% was associated Hansen, Dahl- follow-up for seven years with increased risk of progression of Jorgensen, et al. retinopathy; mean value <8.7% was 199239 associated with diminished risk Reichard, Britz, et RCT (n=97) for five years HbA1c (normal range 3.9% to 5.7%) was al. 199092 comparing intensified treatment reduced from 9.5±0.2 (mean value±SEM) to to regular treatment 7.4±0.1% in the ICT group (P=0.0001) and from 9.5±0.2 to 9.0±0.2% in RT group (P=0.004). Lower HbA1c levels during study significantly reduced risk of deterioration (P=0.01). Improved blood glucose control slowed progression of microangiopathy during 3-year period in patients with non- proliferative retinopathy, but at price of increased frequency of serious hypoglycemic episodes and gain in body weight MC=multi-centre; SEM=standard error of the mean; RRR=relative risk reduction; ICT=intensified treatment; RT=regular treatment
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Type 2 diabetes: Fourteen reports describing six RCTs, and observational studies of retrospective (n=4) and prospective (n=2) designs were found (Table 8). One RCT96 was designed to examine the effect of glycemic control on all-cause mortality and morbidity in newly diagnosed type 2 diabetics. No effect on mortality from intensive glycemic control (<6 mmol/L) after 10 years was detectable. The results also suggest approximately 20 (95% CI 10 to 500) patients would have to apply strict control for 10 years to avoid one complication. Most of these complications were retinopathic. Heart disease was unaffected by tight glycemic control. Individuals with tighter glycemic control did not necessarily do better than those on less strict control suggesting that other factors (such as the drug used) may be more important than simply maintaining glycemic control. Results from the four other RCTS suggest retinopathy and nephropathy may be minimized, however, the reported effect of glycemic control on heart disease has been inconsistent.97
Table 8: Studies of the effect of glycemic control on mortality and morbidity in type 2 diabetes
Report Design Results
Wanjohi, Otieno, Cross-sectional cohort study Only 48% had HbA1c<8% while 36% had 98 et al. 2002 HbA1c>9%; it was established that 26% had albuminuria
Rush, O'Connor, Retrospective time series using HbA1c decreased from 8.56% to 7.33% et al. 200199 HMO database (1994 to 2000). Average Charlson score during same period 1.48 to 1.76 (comorbidity increased) Wagner, Sandhu, Retrospective cohort study Those with 1% HbA1c improvement in 1 year et al. 2001100 maintained for additional year were associated with cost savings Levin, Coburn, et MC RCT of 153 men with type 2 Intensive glycemic control retards al. 2000101 diabetes (1 insulin injection microalbuminuria in patients who have had every morning) comparing type 2 diabetes for several years but may not intensive treatment stepped plan lessen the progressive deterioration of from 1 evening injection of glomerular function insulin, alone or with glipizide, to multiple daily injections designed to attain near-normal glycemia levels (same as Abraira study) Azad, Emanuele, Same as Levin study Our conclusion was that 2 years of et al. 199997 meticulous glycemic control did not decrease overall prevalence of peripheral or autonomic neuropathy. Prevalence rose equivalently and significantly in both treatment arms
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Table 8 cont’d…
Guillausseau, Longitudinal cohort study (n=64) Relative risk for developing retinopathy (RR) Massin, et al. for 7 years was 7.2 (CI 95%: 1.61 to 32.4) in patients 102 1998 with mean HbA1 during follow-up above median value of cohort (8.3%) compared with patients with HbA1 during follow-up below this value UK Prospective MC unblinded RCT (n=4,209). Tight control (<6 mmol/L) did not prevent Diabetes Study Type 2 diabetics stratified into mortality. NNT to avoid one complication (UKPDS) Group overweight versus normal 19.6 (95% CI 10 to 500) patients have to 199896 weight. Overweight randomized apply strict control for 10 years. to strict control with insulin, strict Macrovascular complications unaffected by control with sulfonylurea, less tight control strict control. Normal weight randomized to strict-insulin, strict-sulfonylurea, strict- metformin and less strict. Mean follow-up 10 years Abraira, Colwell, et Same as Levin study Mild and moderate hypoglycemic events al. 1997103 were more frequent in intensive than in standard treatment arm (16.5 versus 1.5 per patient per year respectively). Mean insulin dose was 23% lower in standard treatment arm (p<0.001). There were 61 new cardiovascular events in 24 patients (32%) in intensive treatment arm and in 16 patients (20%) in standard treatment arm (p=0.10). Malmberg 199778 RCT secondary prevention of Those who had intensive insulin treatment diabetic patients (n=620), had absolute reduction of mortality of 11% (majority type 2 diabetes) who (44% versus 33%) compared with regular had suffered an MI randomized therapy group after 3.4 years of follow-up to acute insulin-glucose infusion followed by long-term intensive insulin Rindone, Austin, et Retrospective cohort Glucose control was independent of number al. 1997104 of strips dispensed. Home glucose monitoring strips did not affect the management of patients with NIDDM taking a sulfonylurea agent in primary care setting Ohkubo, RCT of type 2 diabetes (n=110) Those who received multiple insulin Kishikawa, et al. injections had 24% absolute reduction in 199579 progression of retinopathy and 20% reduction in progression of nephropathy after 6 years of follow-up, when compared with conventional therapy group
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Table 8 cont’d…
Gallichan 1994105 Survey plus RCT: SMBG versus Trial showed no significant difference in the urine testing diabetes control of blood testers and urine testers over six months
Morisaki, Cohort (n=114) for 5 years Incidence of progression of retinopathy Watanabe, et al. increased linearly as function of HbA1c level: 106 1994 2% in those with HbA1C<0.070 and 62% in those with HbA1C>0.090 Goldner, RCT comparing insulin, No treatment prevented microangiopathic or Knatterud, et al. tolbutamide and phenformin cardiovascular complications of diabetes, but 197180 (n=1,027) versus placebo trial was stopped prematurely due to rise in phenformin mortality and tolbutamide cardiovascular mortality
MC=multi-centre; CI=confidence interval; MI=myocardial infarction Conclusions The biggest cost of implementing intensive control of blood glucose concentrations in type 2 diabetes relates to the use of home blood glucose monitoring.107 Most diabetics in Canada are type 2, yet it is in this population that evidence seems to be most lacking. In particular, factors other than glycemic control may play an important role in influencing overall morbidity. Whether self-monitoring in this population will lead to better glycemic control or established clinical benefit is unclear. The answers to these questions will lead to large resource implications.
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The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) is a non-profit organization funded by the federal, provincial and territorial governments. (www.ccohta.ca)
PRE-ASSESSMENT Diabetic
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104. Rindone JP, Austin M, Luchesi J. Effect of home blood glucose monitoring on the management of patients with non-insulin dependent diabetes mellitus in the primary care setting. Am J Manag Care 1997;3(9):1335-8. 105. Gallichan MJ. Self-monitoring by patients receiving oral hypoglycaemic agents: a survey and a comparative trial. Pract Diabetes 1994;11:28-30. 106. Morisaki N, Watanabe S, Kobayashi J, Kanzaki T, Takahashi K, Yokote K, et al. Diabetic control and progression of retinopathy in elderly patients: five-year follow-up study. J Am Geriatr Soc 1994;42(2):142-5. 107. Gray A, Raikou M, McGuire A, Fenn P, Stevens R, Cull C, et al. Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41). United Kingdom Prospective Diabetes Study Group. BMJ 2000;320(7246):1373-8.
The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) is a non-profit organization funded by the federal, provincial and territorial governments. (www.ccohta.ca)