Original Article Clinical Care/Education INTRODUCTION DIABETES & METABOLISM JOURNAL

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1 Originl Article Clinicl Cre/Eduction pissn eissn DIABETES & METABOLISM JOURNAL Improvement of Glycosylted Hemoglobin in Ptients with Type 2 Dibetes Mellitus under Insulin Tretment by Reimbursement for Self-Monitoring of Blood Glucose Young Shin Song 1, *, Bo Kyung Koo 1,2,3, *, Sng Wn Kim 1,2, K Hee Yi 1,2, Kichul Shin 2,3, Min Kyong Moon 1,2 1 Deprtment of Internl Medicine, Seoul Ntionl University College of Medicine, Seoul, 2 Deprtment of Internl Medicine, Seoul Metropolitn Government Borme Medicl Center, Seoul, 3 Center for Medicl Informtics, Seoul Metropolitn Government Borme Medicl Center, Seoul, Kore Bckground: In Kore, the costs ssocited with self-monitoring of blood glucose (SMBG) for ptients with type 2 dibetes mellitus (T2DM) under insulin tretment hve been reimbursed since November We investigted whether this new reimbursement progrm for SMBG hs improved the glycemic control in the beneficiries of this policy. Methods: Among ll dult T2DM ptients with 3 months of reimbursement (n=854), subjects without ny chnges in nti-hyperglycemic gents during the study period were selected. The improvement of glycosylted hemoglobin (HbA1c) ws defined s n bsolute reduction in HbA1c 0.6% or n HbA1c level t follow-up <7%. Results: HbA1c levels significntly decresed from 8.5%±1.3% to 8.2%±1.2% during the follow-up (P<0.001) in ll the study subjects (n=409). Among them, 35.5% (n=145) showed significnt improvement in HbA1c. Subjects covered under the Medicl Aid system showed higher prevlence of improvement in HbA1c thn those with medicl insurnce (52.2% vs. 33.3%, respectively, P=0.012). In the improvement group, the bseline HbA1c (P<0.001), fsting C-peptide (P=0.016), nd dily dose of insulin/body weight (P=0.024) showed significnt negtive correltions with the degree of HbA1c chnge. Multivrite nlysis showed tht subjects in the Medicl Aid system were bout 2.5-fold more likely to improve in HbA1c compred to those with medicl insurnce (odds rtio, 2.459; 95% confidence intervl, to 5.314; P=0.022). Conclusion: The reimbursement for SMBG resulted in significnt improvement in HbA1c in T2DM subjects using insulin, which ws more prominent in subjects with poor glucose control t bseline or covered under the Medicl Aid system. Keywords: Blood glucose self-monitoring; Dibetes mellitus, type 2; Hemoglobin A, glycosylted; Insurnce, helth, reimbursement INTRODUCTION Self-monitoring of blood glucose (SMBG) is n essentil tool to ensure optiml blood glucose control. Mjor clinicl trils hve shown tht SMBG cn improve glycemic control mong ptients with both type 2 dibetes mellitus (T2DM) [1,2] nd type 1 dibetes mellitus (T1DM) [3,4]. In prticulr, SMBG is importnt for ll insulin-treted ptients to minimize the risks of both hyper- nd hypoglycemic episodes nd to rech their glycemic gols [5]. The Americn Dibetes Assocition first Corresponding uthor: Min Kyong Moon Deprtment of Internl Medicine, Seoul Metropolitn Government Seoul Ntionl University Borme Medicl Center, Seoul Ntionl University College of Medicine, 20 Borme-ro 5-gil, Dongjk-gu, Seoul 07061, Kore E-mil: mkmoon@snu.c.kr This is n Open Access rticle distributed under the terms of the Cretive Commons Attribution Non-Commercil License ( which permits unrestricted non-commercil use, distribution, nd reproduction in ny medium, provided the originl work is properly cited. *Young Shin Song nd Bo Kyung Koo contributed eqully to this study s first uthors. Received: My 3, 2017; Accepted: Aug. 7, 2017 Copyright 2018 Koren Dibetes Assocition

2 Improved HbA1c by reimbursement for SMBG in T2DM published guidelines for SMBG in 1987 [6] nd the current recommendtions suggest regulr SMBG bsed on the sitution of ech ptient [7]. Considering the importnce of SMBG for dibetes cre, the Americn Dibetes Assocition recommends tht the government should mke the process ccessible nd ffordble for ll ptients who require it. Moreover, it suggests tht insurers nd third-prty pyers reimburse the mediction nd supplies relted to the dily cre of dibetes [8]. In Kore, restricted reimbursement for SMBG ws strted in July 2011 by the Ntionl Helth Insurnce Corportion of Kore (NHI). As the NHI hs covered the entire popultion since 1989, it covered lmost ll reimbursements for cndidtes in Kore. However, t tht time, the reimbursement for SMBG ws limited to glucose test strips prescribed for ptients with T1DM. In November 2015, new ntionwide reimbursement progrm of SMBG for T2DM ptients ws introduced. The rnge of subjects ws expnded to ll dibetic ptients under insulin tretment, nd the covered supplies were expnded to include blood glucose test strips, lncets, insulin syringes, nd pen needles. This extended reimbursement progrm of SMBG ws pplied to both beneficiries of the Medicl Insurnce service nd those under the Medicl Aid Progrm of the NHI; the Medicl Aid Progrm is provided for low-income individuls s prt of socil welfre progrms. The proportions of beneficiries of the Medicl Insurnce service nd Medicl Aid system in the NHI re 97% nd 3%, respectively [9]. The current study imed to investigte whether the introduction of this new reimbursement progrm for SMBG hs improved the glycemic control in T2DM ptients under insulin tretment. METHODS Ptients T2DM ptients who hd visited the Seoul Metropolitn Government Seoul Ntionl University Borme Medicl Center nd strted SMBG reimbursement between November 16, 2015, nd Jnury 29, 2016, were eligible for study inclusion. The index dte ws defined s the dy of the first reimbursement for SMBG. The inclusion criteri were (1) T2DM ptients over 20 yers old receiving tretment with insulin, (2) no chnges in the type of insulin or orl nti-dibetic drugs from 3 months before the index dte to the end of the study period, (3) vilble glycosylted hemoglobin (HbA1c) dt from before nd fter 3 months from the index dte, nd (4) HbA1c level t the index dte 7.0%. We excluded subjects with durtion of insulin tretment of less thn 12 months before the index dte or with history of mlignncy or systemic steroid tretment. Ptients with ny chnges in the type of insulin or orl nti-dibetic drugs from 3 months prior to the index dte nd during the study period were excluded, lthough those with only chnges in dose were llowed. For ech ptient, the bseline nd follow-up dt until 6 months fter the first reimbursement for SMBG were collected retrospectively from electronic medicl records. This study ws conducted in ccordnce with the provisions of the Declrtion of Helsinki for the prticiption of humn subjects in reserch nd ws pproved by the Institutionl Review Bord of Seoul Metropolitn Government Seoul Ntionl University Borme Medicl Center, nd informed consent ws wived for this retrospective study (No / /092). Clinicl nd biochemicl mesurements The plsm glucose nd lipid concentrtions were mesured enzymticlly using Hitchi Automtic Anlyzer B2400 (Hitchi, Tokyo, Jpn), nd HbA1c ws mesured using 200FR system (Toshib, Tokyo, Jpn). Improvement in HbA1c ws defined s n bsolute reduction in HbA1c 0.6% from the bseline or n HbA1c level <7.0% t follow-up. Ptients who met this definition were clssified s the improvement group; otherwise, they were clssified s the no improvement group. A men improvement in HbA1c of 0.6% (6.6 mmol/mol) is in keeping with other studies of T2DM ptients under insulin tretment [10,11]. Sttisticl nlysis Continuous vribles re described s men±stndrd devition (SD) or medin vlues with interqurtile rnge (IQR). Dichotomous vribles re described s counts nd percentges (%). To determine the differences in bseline clinicl chrcteristics ccording to the improvement in HbA1c, Person s chi-squre test for ctegoricl vribles nd the independent t-test or the Wilcoxon-Mnn-Whitney test for continuous vribles were used. The HbA1c nd fsting serum glucose levels nd the men insulin dose t bseline nd t the 3- nd 6-month follow-up were exmined, nd the lst-observtioncrried-forwrd method ws used to hndle dt missing becuse of dt censoring. The glycemic profile before nd fter reimbursement for SMBG ws compred using pired t-tests. Vribles tht were significntly ssocited with improvement 29

3 Song YS, et l. in HbA1c in the univrite nlysis (P<0.05) were subsequently entered into logistic regression models to determine the djusted odds rtios for independent predictors of the improvement in HbA1c. Reltionships between the reduction in the HbA1c level nd other prmeters were evluted using Spermn s correltion coefficient. All sttisticl nlyses were performed using SPSS version 20.0 (IBM Co., Armonk, NY, USA). Missing vlues were hndled using the lst-observtion-crried-forwrd method, nd sttisticl significnce ws defined s two-sided P vlues <0.05. RESULTS Bseline clinicl chrcteristics of the study subjects Among the totl number of T2DM ptients with reimbursement for SMBG (n=854), 409 ptients with T2DM were included in the nlysis (Supplementry Fig. 1). The medin follow-up durtion ws 6.1 months (IQR, 5.6 to 6.5 months). The medin ge of the study prticipnts ws 67 yers (IQR, 60 to 73 yers), the men durtion of dibetes ws 19.1±8.0 yers, nd the medin HbA1c ws 8.2% (IQR, 7.5% to 9.2%). Among ll study prticipnts, 77.0% hd tken insulin for >5 yers. Those under the Medicl Insurnce nd Medicl Aid systems ccounted for 88.8% (363/409) nd 11.2% (46/409) of the subjects, respectively (Tble 1). Ptients under the Medicl Aid system were younger nd hd higher body mss index, higher HbA1c nd fsting serum glucose levels, higher frequency of dibetic retinopthy, nd higher dily doses of insulin thn those with Medicl Insurnce (Supplementry Tble 1). The most prevlent concomitnt orl nti-dibetic mediction ws metformin, which ws tken by 74.8% of the study subjects. Sulfonylure nd dipeptidyl peptidse-4 inhibitors were prescribed for 43.5% nd 23.5% of the subjects, respectively (Supplementry Tble 2). Chnges in glycemic control fter reimbursement for SMBG After 6 months of reimbursement for SMBG, HbA1c levels significntly decresed from bseline vlue of 8.5%±1.3% to 8.2%±1.2% (P<0.001), nd fsting serum glucose levels lso decresed from bseline of 146.0±64.0 to 138.5±55.9 mg/dl (P=0.015) (Tble 2). Sensitivity nlyses ccording to the insulin regimen confirmed tht HbA1c levels significntly decresed regrdless of the type of regimen (Supplementry Tble 3). Of the 409 ptients, 145 (35.5%) showed significnt improvements in HbA1c: 136 chieved n bsolute reduction in HbA1c 0.6%, 47 hd HbA1c levels t follow-up <7%, nd 38 were stisfied with both conditions. In subjects with improvement, the men HbA1c nd fsting serum glucose levels t bseline were 9.1% nd mg/dl, nd the men chnges in those levels during the follow-up were 1.4% nd 31.9 mg/dl, respectively (P<0.001 for both) (Tble 2). In contrst, HbA1c in the no improvement group significntly incresed, from 8.2%±1.0% to 8.5%±1.0% (P<0.001). The men dily dose of insulin ws unchnged both in subjects with nd without improvement. Regrding dosge chnges in orl nti-dibetic drugs, most ptients mintined the sme dosge during the study period (93.2% of the improvement group nd 96.6% of the no improvement group) (Supplementry Tble 4). Moreover, there were no significnt differences in the proportion of ptients with incresed or decresed dosges of orl nti-dibetic drugs between the two groups. Compred to the subjects without improvement, those with improvement hd significntly higher bseline HbA1c (9.1± 1.6 mg/dl vs. 8.2±1.0 mg/dl, P<0.001). They lso showed higher distolic blood pressure t bseline (Tble 1); however, the sttisticl significnce ws lost when the subgroup nlysis ws performed in ptients who were not tking nti-hypertensive drugs (P=0.417). Furthermore, 52.2% (24/46) of the subjects under the Medicl Aid system showed improvement in their HbA1c levels, which ws higher proportion thn in those with Medicl Insurnce (33.3%, 121/363; P=0.012). We compred the trends of the chnge in HbA1c levels during the study period between both groups nd found tht subjects in the improvement group showed significnt grdul reduction in HbA1c levels (P<0.001 from the pired t-test between bseline vs. 3 months nd 3 months vs. 6 months) (Fig. 1). Considering tht significntly higher bseline HbA1c levels in the improvement group might ffect the chnge in HbA1c levels during the follow-up period, we lso compred the chnge in HbA1c levels from 3 months. HbA1c levels t 3 months were not different between the two groups (Supplementry Tble 5). HbA1c levels t 6 months were significntly lower thn HbA1c levels t 3 months in the improvement group; in contrst, the no improvement group showed significntly incresed levels of HbA1c during the sme period (Supplementry Tble 5). Furthermore, the mount of chnges in HbA1c levels during tht period ws significntly lower in the improvement group ( 0.67%±1.21% vs. 0.12%±1.03%, P<0.001). 30

4 Improved HbA1c by reimbursement for SMBG in T2DM Tble 1. Bseline chrcteristics ccording to improvement of HbA1c Chrcteristic Totl Improvement + P vlue Number Age, yr 67 (60 73) 67 (59 72) 67 (60 75) Mle sex 194 (47.4) 121 (45.8) 73 (50.3) Body mss index, kg/m ( ) 24.5 ( ) 25.5 ( ) Durtion of dibetes, yr 19.1± ± ± Systolic blood pressure, mm Hg 128.6± ± ± Distolic blood pressure, mm Hg 72.4± ± ± HbA1c, % 8.5± ± ±1.6 <0.001 Fsting serum glucose, mg/dl 137 ( ) 126 ( ) 154 ( ) <0.001 Fsting C-peptide, ng/ml 1.6 ( ) 1.6 ( ) 1.6 ( ) Urine lbumin to cretinine rtio 37.5 ( ) 36.7( ) 38.7( ) BUN, mg/dl 16 (13 22) 16 (13 21) 17 (14 24) Cretinine, mg/dl 0.9 ( ) 0.9 ( ) 0.9 ( ) Estimted GFR, ml/min/1.73 m ± ± ± AST, IU/L 23 (19 31) 23 (20 30) 22 (17 31) ALT, IU/L 22 (16 32) 22 (17 33) 21 (15 29) Totl cholesterol, mg/dl 146 ( ) 145 ( ) 151 ( ) Triglyceride, mg/dl 123 (91 168) 123 (93 162) 120 (86 192) HDL-C, mg/dl 43 (37 51) 45 (37 52) 43 (36 51) LDL-C, mg/dl 79 (65 97) 77 (64 94) 84 (65 97) Hypertension 324 (79.2) 212 (80.3) 112 (77.2) History of CAD 45 (11.0) 29 (11.0) 16 (11.0) History of CVA 25 (6.1) 16 (6.10) 9 (6.2) Dibetic retinopthy 204/311 (65.6) 133/197 (67.5) 71/114 (62.3) Non-prolifertive 131/311 (42.1) 88/197 (44.7) 43/114 (37.7) Prolifertive 73/311 (23.5) 45/197 (22.8) 28/114 (24.6) Dibetic nephropthy 236/408 (57.8) 151/264 (57.2) 85/144 (59.0) Microlbuminuri 123/393 (31.3) 85/254 (33.5) 38/139 (27.3) Overt proteinuri 84/393 (21.4) 49/254 (19.3) 35/139 (25.2) CKD stge 3 98/408 (24.0) 65/264 (24.6) 33/144 (22.9) CKD stge /408 (9.3) 18/264 (6.8) 20/144 (13.9) Durtion of insulin tretment, yr (23.0) 61 (23.1) 33 (22.8) >5 315 (77.0) 203 (76.9) 112 (77.2) Dily dose of insulin, IU 34 (22 52) 34 (22 52) 32 (22 52) Ntionl Helth Insurnce service Medicl Aid 46 (11.2) 22 (8.3) 24 (16.6) Medicl Insurnce 363 (88.8) 242 (91.7) 121 (83.4) Durtion of dibetes 20 yr 204/403 (50.6) 128/259 (49.4) 76/144 (52.8) Bseline HbA1c >8.2% 199 (48.7) 107 (40.5) 92 (63.4) <0.001 Presence of hypoglycemi 46/406 (11.3) 33/261 (12.6) 13/145 (9.0) <1/mo 13/406 (3.2) 9/261 (3.4) 4/145 (2.8) 1 3/mo 31/406 (7.6) 23/261 (8.8) 8/145 (5.5) >3/mo 2/406 (0.5) 1/261 (0.4) 1/145 (0.7) Use of ntihypertensive drug 308 (75.3) 198 (75.0) 110 (75.9) Use of sttin 331 (80.9) 223 (84.5) 108 (74.5) Vlues re presented s medin (interqurtile rnge), number (%), or men±stndrd devition. HbA1c, glycosylted hemoglobin; BUN, blood ure nitrogen; GFR, glomerulr filtrtion rte; AST, sprtte trnsferse; ALT, lnine trnsferse; HDL- C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol; CAD, coronry rtery disese; CVA, cerebrovsculr ccident; CKD, chronic kidney disese. Defined s bsolute reduction of HbA1c 0.6% or HbA1c level t follow-up <7%. 31

5 Song YS, et l. Tble 2. Comprison of glycemic profile between before nd fter reimbursement for self-monitoring of blood glucose Vrible Bseline After 6 months P vlue b Totl HbA1c, % 8.5± ±1.2 <0.001 Fsting serum glucose, mg/dl 146.0± ± Men insulin dose, IU/dy 41.0± ± No improvement HbA1c, % 8.2± ±1.0 <0.001 Fsting serum glucose, mg/dl 134.1± ± Men insulin dose, IU/dy 42.1± ± Improvement HbA1c, % 9.1± ±1.2 <0.001 Fsting serum glucose, mg/dl 171.1± ±63.4 <0.001 Men insulin dose, IU/dy 40.6± ± Vlues re presented s men±stndrd devition. HbA1c, glycosylted hemoglobin. Vlue t 6 months from the index dte (lst observtion crried forwrd), b P vlue clculted by pired t-test. HbA1c (%) Bseline 3 Months 6 Months Fig. 1. The chnge in HbA1c during the follow-up periods. Comprisons of the glycosylted hemoglobin (HbA1c) levels t bseline nd 3 nd 6 months fter the first reimbursement for self-monitoring of blood glucose s determined by the pired t-test. All dt re expressed s men±sem. P<0.05 vs. bseline, b P<0.05 vs. 3 months. Correltions between chnges in HbA1c levels nd clinicl vribles Subsequently, we investigted whether ny clinicl prmeters determined chnges in HbA1c levels in the improvement group. Bseline HbA1c, bseline fsting serum glucose level, body mss index, fsting C-peptide, dily dose of insulin, nd body weight-djusted dily dose of insulin showed significnt Totl Improvement No improvement, b, b Tble 3. Correltion of chnge in HbA1c levels with clinicl fctors in the improvement group Vrible r P vlue Age Durtion of dibetes Body mss index HbA1c <0.001 Fsting serum glucose <0.001 C-peptide Urine lbumin to cretinine rtio BUN Cretinine AST ALT Totl cholesterol Triglyceride HDL-C LDL-C Totl dily dose of insulin Totl dily dose of insulin/body weight HbA1c, glycosylted hemoglobin; BUN, blood ure nitrogen; AST, sprtte trnsferse; ALT, lnine trnsferse; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol. Spermn s correltion coefficient. negtive correltions with the degree of HbA1c chnge (Tble 3). Tht is, increse in these vribles ws ssocited with de- 32

6 Improved HbA1c by reimbursement for SMBG in T2DM Tble 4. Determinnts for improvement in HbA1c levels Vrible Medicl Aid vs. Insurnce Model 1 Model 2 b Model 3 c Model 4 d OR (95% CI) P vlue OR (95% CI) P vlue OR (95% CI) P vlue OR (95% CI) P vlue ( ) HbA1c ( ) Fsting serum glucose ( ) Use of sttin ( ) ( ) < ( ) < ( ) ( ) ( ) < ( ) < ( ) ( ) ( ) < ( ) ( ) ( ) HbA1c, glycosylted hemoglobin; OR, odds rtio; CI, confidence intervl. Model 1: undjusted, b Model 2: djusted for ge nd sex, c Model 3: djusted for ge, sex, benefit type of Ntionl Helth Insurnce service, bseline HbA1c, nd use of sttin, d Model 4: djusted for ge, sex, benefit type of Ntionl Helth Insurnce service, bseline HbA1c, nd use of sttin, body mss index, presence of dibetic retinopthy, nd dily insulin dose < crese in HbA1c levels. Especilly, bseline HbA1c nd fsting serum glucose levels showed moderte-to-strong inverse correltions with chnges in HbA1c (r= 0.694, P<0.001; r= 0.349, P<0.001, respectively). Determinnts for improvement of the HbA1c level To evlute the predictors of improvement in HbA1c, multivrite nlysis ws performed using the bseline clinicl fctors tht significntly differed between those with nd without improvement, nmely the type of NHI service benefit, bseline HbA1c, fsting serum glucose, nd use of sttins. The bseline HbA1c level ws ctegorized s 8.2% nd >8.2% ccording to the medin level. All the bove vribles remined sttisticlly significnt determinnts for the improvement in HbA1c even fter djustment for ge, sex, nd potentil confounders (Model 3, Tble 4). In ddition, to confirm the effects of the Medicl Aid system, vribles with significnt differences between the groups of Medicl Aid nd Medicl Insurnce, including body mss index, presence of dibetic retinopthy, nd dily insulin dose, were dditionlly djusted (Model 4). T2DM ptients supported by the Medicl Aid system were bout 2.5-fold more likely to show n improvement in HbA1c levels compred to ptients with Medicl Insurnce (odds rtio, 2.459; 95% confidence intervl, to 5.314; P=0.022). DISCUSSION Kore s newly introduced reimbursement progrm of SMBG significntly improved glycemic control in T2DM ptients treted with insulin. In prticulr, ptients with high bseline HbA1c levels hd greter reduction in HbA1c, nd those reimbursed under the Medicl Aid system were more likely to chieve improvement in glycemic control. Furthermore, HbA1c reduction ws mintined for 6 months fter the initition of the reimbursement progrm. SMBG is crucil for evluting drug response, djusting insulin doses, nd preventing hypoglycemi. It helps control dibetes in number of wys, including providing informtion regrding the pproprite food choices nd quntities, ssisting in insulin dosing, nd identifying dynmic blood glucose profiles tht cn led to improvements in glycemic control [12,13], lower risks of long-term dibetic complictions [4,14], nd reduce helth cre costs [8]. A negtive ssocition between the frequency of SMBG nd the blood glucose levels ws lso reported mong insulin-treted T2DM ptients [15] s well s T1DM [3,16], lthough current evidence regrding the usefulness of SMBG in those with T2DM who do not tke insulin is insufficient [16-19]. Despite the clinicl importnce of SMBG in insulin-treted dibetic ptients, reimbursement policies vry between countries [20]. In Chin, glucometers nd test strips for SMBG re currently not covered by government-provided medicl insurnce [21]. In contrst, mny Europen nd North Americn countries lrgely cover the cost for SMBG, even for those without insulin tretment. The United Sttes nd Cnd offer 75% to 80% reimbursement for SMBG equipment nd supplies, lthough the mount of supplies tht re covered differs between insulin-dependent nd non-insulin-dependent beneficiries [22,23]. Similrly, in Austrli, ptients with dibetes re eligible for reimbursement; however, those with T2DM who do not 33

7 Song YS, et l. use insulin re reimbursed only for the initil 6 months due to limited evidence of the benefits of SMBG in this popultion [24]. Frnce nd Itly provide reimbursement for ll T2DM ptients under insulin tretment without ny restrictions, with the exception of the number of tests for T2DM ptients without insulin tretment [25]. A limited number of studies hve investigted the cost-effectiveness of the reimbursement of SMBG. Our dt provide evidence tht ech country s reimbursement policies should be refined considering the popultion distribution of the socioeconomic sttus nd burden of dibetes, s well s the merits of improving glycemic control. Interestingly, the ptients covered by the Medicl Aid system were more likely to chieve improvement in glycemic control in our study, suggesting tht the cost of SMBG is n importnt brrier for poorer ptients nd tht the mount of reimbursement or the refinement of the beneficiries of this helth policy should be djusted fter nlysis of the long-term cost-effectiveness. In this study, glucose control in T2DM ptients under insulin tretment ws improved by reimbursement for SMBG, lthough there ws no difference in the dose of insulin or orl nti-dibetic drugs fter the reimbursement, even in the improvement group. This suggests tht the observed improvement might be cused by modified behvior, including food intke, exercise, nd tking mediction regulrly, rther thn incresing doses of mediction. In prticulr, subjects with high HbA1c levels showed greter improvement in HbA1c fter reimbursement. This significnt correltion remined when we nlyzed the dt ccording to the reltive proportions of the improvement of HbA1c.These results suggest tht the new reimbursement progrm my provide motivtion to improve dibetic cre, especilly in uncontrolled dibetic ptients with previously poor complince. Some possible limittions of our study need to be discussed. First, we did not nlyze the ctul frequency of SMBG in our study subjects before nd fter the reimbursement, which resulted in the inbility to confirm tht reimbursement for SMBG incresed the frequency of SMBG. Second, s ll T2DM ptients under insulin tretment re eligible for the reimbursement, our study could not hve control subjects, tht is, subjects without reimbursement. Insted, we compred the glucose level before nd fter the reimbursement for SMBG in ech subject nd nlyzed the fctors ffecting the mount of chnge in glucose levels. Assessment of the improvement glucose levels in ech ptient might lso be importnt, s the benefit from the reimbursement for SMBG in ech individul cn be ssessed nd there is lower risk of confounders. Furthermore, nlysis of the chnge in glucose levels fter the reimbursement for SMBG without considering the ctul frequency of SMBG in ech ptient might be more suitble to pprise the benefits of reimbursement for SMBG policy in the relworld setting. Third, there ws difference in bseline HbA1c levels between the groups of Medicl Aid nd Medicl Insurnce, nd it cn be confounder. However, we could overcome this fctor by djusting the HbA1c level in the multivrite nlysis. In ddition, considering higher bseline HbA1c in the improvement group compred to the no improvement group, we compred the chnge in HbA1c levels not only from the bseline but lso from the 3 months; there ws no difference between the two groups, confirming tht the current definition of improvement of HbA1c could successfully differentite individuls with HbA1c improvement mong the study subjects. Finlly, this study nlyzed glucose levels for only 6 months fter the initition of reimbursement for SMBG. The long-term benefits should be ssessed in future studies, s the helth policy ssocited with the reimbursement for SMBG might need to be djusted ccordingly. In conclusion, the new reimbursement progrm for SMBG in Kore improved the glycemic control in T2DM ptients under insulin tretment; this improvement ws especilly prominent in subjects with poor glycemic control t the bseline or covered under the Medicl Aid system. CONFLICTS OF INTEREST No potentil conflict of interest relevnt to this rticle ws reported. ACKNOWLEDGMENTS This study ws supported by the Cretive Industril Technology Development Progrm (No ) nd the Kore Meteorologicl Administrtion Reserch nd Development Progrm (No. KMIPA ). REFERENCES 1. Polonsky WH, Fisher L, Schikmn CH, Hinnen DA, Prkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wgner RS. Structured self-monitoring of blood glucose significntly reduces 34

8 Improved HbA1c by reimbursement for SMBG in T2DM A1C levels in poorly controlled, noninsulin-treted type 2 dibetes: results from the Structured Testing Progrm study. Dibetes Cre 2011;34: Frnciosi M, Pellegrini F, De Berrdis G, Belfiglio M, Cvliere D, Di Nrdo B, Greenfield S, Kpln SH, Scco M, Tognoni G, Vlentini M, Nicolucci A; QuED Study Group. The impct of blood glucose self-monitoring on metbolic control nd qulity of life in type 2 dibetic ptients: n urgent need for better eductionl strtegies. Dibetes Cre 2001;24: Miller KM, Beck RW, Bergenstl RM, Golnd RS, Hller MJ, McGill JB, Rodriguez H, Simmons JH, Hirsch IB; T1D Exchnge Clinic Network. Evidence of strong ssocition between frequency of self-monitoring of blood glucose nd hemoglobin A1c levels in T1D exchnge clinic registry prticipnts. Dibetes Cre 2013;36: Dibetes Control nd Complictions Tril Reserch Group, Nthn DM, Genuth S, Lchin J, Clery P, Crofford O, Dvis M, Rnd L, Siebert C. The effect of intensive tretment of dibetes on the development nd progression of long-term complictions in insulin-dependent dibetes mellitus. N Engl J Med 1993;329: Goldstein DE, Little RR, Lorenz RA, Mlone JI, Nthn DM, Peterson CM; Americn Dibetes Assocition. Tests of glycemi in dibetes. Dibetes Cre 2004;27 Suppl 1:S Consensus sttement on self-monitoring of blood glucose. Dibetes Cre 1987;10: Americn Dibetes Assocition. Stndrds of medicl cre in dibetes: Dibetes Cre 2010;33 Suppl 1:S Americn Dibetes Assocition. Third-prty reimbursement for dibetes cre, self-mngement eduction, nd supplies. Dibetes Cre 2014;37 Suppl 1:S Seong SC, Son MS Ntionl Helth Insurnce Sttisticl Yerbook. Wonju: Helth Insurnce Review nd Assessment Service of Kore; Yki-Jrvinen H, Rosenstock J, Durn-Grci S, Pinnetti S, Bhttchry S, Thiemnn S, Ptel S, Woerle HJ. Effects of dding lingliptin to bsl insulin regimen for indequtely controlled type 2 dibetes: 52-week rndomized, double-blind study. Dibetes Cre 2013;36: Hong ES, Khng AR, Yoon JW, Kng SM, Choi SH, Prk KS, Jng HC, Shin H, Wlford GA, Lim S. Comprison between sitgliptin s dd-on therpy to insulin nd insulin dose-increse therpy in uncontrolled Koren type 2 dibetes: CSI study. Dibetes Obes Metb 2012;14: Poolsup N, Suksomboon N, Rttnsookchit S. Met-nlysis of the benefits of self-monitoring of blood glucose on glycemic control in type 2 dibetes ptients: n updte. Dibetes Technol Ther 2009;11: Welschen LM, Bloemendl E, Nijpels G, Dekker JM, Heine RJ, Stlmn WA, Bouter LM. Self-monitoring of blood glucose in ptients with type 2 dibetes who re not using insulin: systemtic review. Dibetes Cre 2005;28: Burge MR. Lck of complince with home blood glucose monitoring predicts hospitliztion in dibetes. Dibetes Cre 2001; 24: Rosenstock J, Dvies M, Home PD, Lrsen J, Koenen C, Schernthner G. A rndomised, 52-week, tret-to-trget tril compring insulin detemir with insulin glrgine when dministered s dd-on to glucose-lowering drugs in insulin-nive people with type 2 dibetes. Dibetologi 2008;51: Krter AJ, Ackerson LM, Drbinin JA, D Agostino RB Jr, Ferrr A, Liu J, Selby JV. Self-monitoring of blood glucose levels nd glycemic control: the Northern Cliforni Kiser Permnente Dibetes registry. Am J Med 2001;111: Simon J, Gry A, Clrke P, Wde A, Neil A, Frmer A; Dibetes Glycemic Eduction nd Monitoring Tril Group. Cost effectiveness of self monitoring of blood glucose in ptients with non-insulin treted type 2 dibetes: economic evlution of dt from the DiGEM tril. BMJ 2008;336: O Kne MJ, Bunting B, Copelnd M, Cotes VE; ESMON study group. Efficcy of self monitoring of blood glucose in ptients with newly dignosed type 2 dibetes (ESMON study): rndomised controlled tril. BMJ 2008;336: Frmer A, Wde A, Goyder E, Yudkin P, French D, Crven A, Holmn R, Kinmonth AL, Neil A. Impct of self monitoring of blood glucose in the mngement of ptients with non-insulin treted dibetes: open prllel group rndomised tril. BMJ 2007;335: Czuprynik L, Brki L, Bolgrsk S, Bronisz A, Broz J, Cypryk K, Honk M, Jnez A, Krnic M, Llic N, Mrtink E, Rhelic D, Romn G, Tnkov T, Vrkonyi T, Wolnik B, Zherdov N. Selfmonitoring of blood glucose in dibetes: from evidence to clinicl relity in Centrl nd Estern Europe: recommendtions from the interntionl Centrl-Estern Europen expert group. Dibetes Technol Ther 2014;16: Ji L, Su Q, Feng B, Shn Z, Hu R, Xing X, Xue Y. Glycemic control nd self-monitoring of blood glucose in Chinese ptients with type 2 dibetes on insulin: bseline results from the COMPASS study. Dibetes Res Clin Prct 2016;112: Centers for Medicre & Medicid Services: Medicre coverge 35

9 Song YS, et l. of blood glucose monitors nd testing supplies, Avilble from: Medicre-Lerning-Network-MLN/MLNMttersArticles/ downlods/se1008.pdf (cited 2017 Sep 8). 23. Ontrio Ministry of Helth And Long-Term Cre: Blood glucose test strips. Avilble from: (cited 2017 Sep 8). 24. The Deprtment of Helth, Austrlin Government: Ntionl Dibetes Services Scheme (NDSS) Avilble from: helth-pbs-helthpro-supply-ndss.htm (cited 2017 Sep 8). 25. Schefer E, Schnell G, Sonsll J. Obtining reimbursement in Frnce nd Itly for new dibetes products. J Dibetes Sci Technol 2015;9:

10 Improved HbA1c by reimbursement for SMBG in T2DM Supplementry Tble 1. Bseline chrcteristics ccording to the type of Ntionl Helth Insurnce service Chrcteristic Medicl Aid Medicl Insurnce P vlue Number Age, yr 64.5 ( ) 67.0 ( ) Mle sex 20 (43.5) 174 (47.9) Body mss index, kg/m ( ) 24.4 ( ) Durtion of dibetes, yr 17.9± ± Systolic blood pressure, mm Hg 128.2± ± Distolic blood pressure, mm Hg 74.4± ± HbA1c, % 9.2± ± Fsting serum glucose, mg/dl 161 ( ) 134 ( ) Fsting C-peptide, ng/ml 1.2 ( ) 1.6 ( ) Urine lbumin to cretinine rtio 35.8 ( ) 38.1 ( ) BUN, mg/dl 16 (12 24) 17 (14 22) Cretinine, mg/dl 0.9 ( ) 0.9 ( ) Estimted GFR, ml/min/1.73 m ± ± AST, IU/L 21 (16 31) 23 (19 30) ALT, IU/L 19 (14 28) 22 (16 32) Totl cholesterol, mg/dl 153 ( ) 145 ( ) Triglyceride, mg/dl 130 (94 189) 122 (90 167) HDL-C, mg/dl 46 (35 51) 43 (37 52) LDL-C, mg/dl 85 (70 101) 78 (64 93) Hypertension 40 (87.0) 284 (78.2) History of CAD 5 (10.9) 40 (11.0) History of CVA 3 (6.5) 22 (6.1) Dibetic retinopthy 33/41 (80.5) 171/270 (63.3) Non-prolifertive 20/41 (48.8) 111/270 (41.1) Prolifertive 13/41 (31.7) 60/270 (22.2) Dibetic nephropthy 31/46 (67.4) 205/362 (56.6) Microlbuminuri 16/43 (37.2) 107/350 (30.6) Overt proteinuri 9/43 (20.9) 75/350 (21.4) CKD stge 3 16/46 (34.8) 82/362 (22.7) CKD stge 4 5 4/46 (8.7) 34/362 (9.4) Durtion of insulin tretment, yr (26.1) 82 (22.6) >5 34 (73.9) 281 (77.4) Dily dose of insulin, IU 43 (30 64) 32 (22 50) Durtion of dibetes 20 yr 21/45 (46.7) 183/358 (51.1) Bseline HbA1c >8.2% 25 (54.3) 174 (47.9) Presence of hypoglycemi 3/46 (6.5) 43/360 (11.9) <1/mo 0/46 (0.0) 13/360 (3.6) 1 3/mo 3/46 (6.5) 28/360 (7.8) >3/mo 0/46 (0.0) 2/360 (0.6) Use of ntihypertensive drug 40 (87.0) 268 (73.8) Use of sttin 36 (78.3) 295 (81.3) Vlues re presented s medin (interqurtile rnge), number (%), or men±stndrd devition. HbA1c, glycosylted hemoglobin; BUN, blood ure nitrogen; GFR, glomerulr filtrtion rte; AST, sprtte trnsferse; ALT, lnine trnsferse; HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol; CAD, coronry rtery disese; CVA, cerebrovsculr ccident; CKD, chronic kidney disese. 37

11 Song YS, et l. Supplementry Tble 2. Bseline chrcteristics of types of prescription drugs ccording to improvement of glycosylted hemoglobin Chrcteristic Totl Improvement + Type of insulin Insulin glrgine 171 (41.8) 118 (44.7) 53 (36.6) NPH 75 (18.3) 48 (18.2) 27 (18.6) Mixed insulin 180 (44.0) 109 (41.9) 715 (49.0) Rpid/short-cting insulin 52 (12.7) 37 (14.0) 15 (10.3) Type of orl ntidibetic drug Metformin 306 (74.8) 204 (77.3) 102 (70.3) Sulfonylure 178 (43.5) 126 (47.7) 52 (35.9) DPP4 inhibitor 96 (23.5) 60 (22.7) 36 (24.8) GLP-1 gonist 1 (0.2) 1 (0.4) 0 SGLT2 inhibitor 15 (3.7) 5 (1.9) 10 (6.9) Thizolidinedione 12 (2.9) 11 (4.2) 1 (0.7) α-glucosidse inhibitor 11 (2.7) 6 (2.3) 5 (3.4) Use of ntihypertensive drug 308 (75.3) 198 (75.0) 110 (75.9) P vlue ACE inhibitor 256 (62.6) 167 (63.3) 89 (61.4) β-blocker 95 (23.2) 62 (23.5) 33 (22.8) Use of sttin 331 (80.9) 223 (84.5) 108 (74.5) Vlues re presented s number (%). NPH, neutrl protmine Hgedorn; DPP4, dipeptidyl peptidse-4; GLP-1, glucgon-like peptide-1; SGLT2, sodium/glucose cotrnsporter 2; ACE, ngiotensin-converting enzyme. Defined s bsolute reduction of HbA1c 0.6% or HbA1c level t follow-up <7%. 38

12 Improved HbA1c by reimbursement for SMBG in T2DM Supplementry Tble 3. Comprison of glycemic profile between t bseline nd 6 months fter reimbursement for self-monitoring of blood glucose ccording to the type of insulin regimen Vrible Bseline After 6 months P vlue b Bsl-only insulin (n=178) HbA1c, % 8.4± ±1.1 <0.001 Fsting serum glucose, mg/dl 135.7± ± Men insulin dose, IU/dy 28.0± ± Premixed insulin (n=180) HbA1c, % 8.7± ±1.2 <0.001 Fsting serum glucose, mg/dl 159.0± ± Men insulin dose, IU/dy 47.0± ± Bsl-bolus (MDI) (n=51) HbA1c, % 8.7± ± Fsting serum glucose, mg/dl 143.5± ± Men insulin dose, IU/dy 65.2± ± Vlues re presented s men±stndrd devition. HbA1c, glycosylted hemoglobin; MDI, multiple dily injection. Vlue t 6 months from the index dte (lst observtion crried forwrd), b P vlue clculted by pired t-test. 39

13 Song YS, et l. Supplementry Tble 4. Dosge chnges in insulin nd orl nti-dibetic drugs during the study period ccording to improvement in glycosylted hemoglobin Dosge chnge Orl nti-dibetic drugs Improvement (n=264) + (n=145) Mintennce 246 (93.2) 140 (96.6) Increse 5 (1.9) 3 (2.1) Metformin/SU/metformin+SU 2/3/0 1/1/1 Decrese 11 (4.2) 2 (1.4) Metformin/SU/metformin+SU/AGI 0/7/4/0 1/0/0/1 Increse (SU) nd decrese (metformin) 2 (0.8) Vlues re presented s number (%). SU, sulfornylure; AGI, α-glucosidse inhibitor. P vlue 40

14 Improved HbA1c by reimbursement for SMBG in T2DM Supplementry Tble 5. The trends of the chnge in HbA1c during the study period in subjects with nd without improvement in HbA1c Vrible No improvement HbA1c Improvement P vlue 3 Months 8.3± ± Month 8.2± ±1.6 b < Months 8.5±1.2 b,c 8.1±1.3 c Months 8.4±1.1c 7.7±1.2 b,c <0.001 Chnge from 3 months 0.12± ±1.21 <0.001 Chnge from the bseline 0.17± ±1.04 <0.001 Vlues re presented s men±stndrd devition. HbA1c, glycosylted hemoglobin. Compred subjects with nd without improvement using independent t-test, b P<0.05 compred to the HbA1c levels t 3 months using pired t-test, c P<0.05 compred to the HbA1c levels from the bseline using pired t-test. 41

15 Song YS, et l. 854 T2DM ptients with insulin tretment who strted to be reimbursed for SMBG between 16 November 2015 nd 29 Jnury Chnges in the type of insulin or OAD 63 Durtion of insulin tretment <12 months 34 History of mlignncy of systemic steroid 3 Insufficient dt of HbA1c 67 HbA1c <0.7% 409 Ptients included in the present nlysis Supplementry Fig. 1. Flow chrt of ptients included in the study. T2DM, type 2 dibetes mellitus; SMBG, self-monitoring of blood glucose; OAD, orl ntidibetic drug; HbA1c, glycosylted hemoglobin. 42

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