ORIGINAL INVESTIGATION. Use of a Blood Glucose Monitoring Manual to Enhance Monitoring Adherence in Adults With Diabetes

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1 ORIGINAL INVESTIGATION Use of a Blood Glucose Monitoring Manual to Enhance Monitoring Adherence in Adults With Diabetes A Randomized Controlled Trial Elaine C. Moreland, MD; Lisa K. Volkening, BA; Margaret T. Lawlor, MS, CDE; Karen A. Chalmers, MS, RD, CDE; Barbara J. Anderson, PhD; Lori M. B. Laffel, MD, MPH Background: Frequent blood glucose (BG) monitoring is a critical component of diabetes management, yet many barriers exist to consistent monitoring. Methods: In this randomized controlled trial, we sought to determine if an educational manual, the Blood Sugar Monitoring Owner s Manual (BGMOM), could increase adherence to BG monitoring by helping patients form realistic expectations and responses to BG monitoring results. The 199 participants were recruited from a multidisciplinary diabetes clinic and had high-risk diabetes (hemoglobin A 1C 8.%); 35% had type 1 diabetes mellitus. Participants were randomized to 1 of 3 groups: BGMOM intervention (BGM ), attention control (BG meter only []), or standard care (SC). The BGM and groups received BG meters and meter education; the BGM group also received BGMOM booklets. The SC group received usual care. Data gathered during 6 months of follow-up included BG monitoring frequency and hemoglobin A 1C measurement. Results: Monitoring frequency increased significantly in the BGM group (1.9±1.3 to 2.8±1.5 times daily, P.1) but only slightly in the group (1.7±1.3 to 2.±1.3 times daily). The BGM group experienced the greatest improvement in hemoglobin A 1C level (BGM :.13±1.28; :.4±1.31; SC:.4±1.1). Further, a higher percentage of those in the BGM group (61%) improved their glycemic control compared with the other groups (44%; P=.5). Finally, the BGM group displayed the most knowledge about the definition of hemoglobin A 1C (P=.4) and reported the least amount of negative affect about out-of-range BG monitoring results (P=.3). Conclusion: As an adjunct to standard diabetes education and support, a manual such as the BGMOM can help optimize BG monitoring and glycemic control. Arch Intern Med. 6;166: Author Affiliations: Sections on Genetics and Epidemiology and Behavioral and Mental Health, Joslin Diabetes Center, Boston, Mass. Dr Anderson is currently with the Department of Pediatrics, Endocrinology and Metabolism Section, Baylor College of Medicine, Houston, Tex. Dr Moreland is currently with the Department of Pediatrics, Division of Pediatric Endocrinology, University of Alabama, Birmingham. SUCCESSFUL MANAGEMENT OF diabetes, as with any chronic illness, requires self-care. Many psychosocial determinants affect self-management of diabetes, including diabetesspecific knowledge, social isolation and support, health beliefs and attitudes, illness severity, and treatment modality. 1 Conflicting expectations and perceptions between health care professionals and patients can significantly hinder establishment of proper self-care. 2 Indeed, diabetes education alone has not consistently produced behavior modifications that promote improvement in glycemic control. 3 Thus, educational support must convey realistic expectations regarding diabetes management and address issues related to diabetes-specific emotions or affect to encourage successful behavior change. Blood glucose (BG) monitoring is the foundation of diabetes management, because BG monitoring results provide guidelines for meal planning, exercise, and medication use. More frequent BG monitoring has been associated with better glycemic control in patients with type 1 and type 2 diabetes mellitus Nonetheless, numerous barriers to BG monitoring exist, including discomfort, inconvenience, cost, difficulty performing the task, lack of knowledge regarding how to interpret BG monitoring results, and fear of bad BG monitoring results Annual sales of BG strips suggest that patients with type 1 diabetes monitor BG levels 1 to 2 times daily and patients with type 2 diabetes monitor BG levels 1 to 2 times weekly. 13,15,16 Recognizing the link between BG monitoring and improved glycemic control, 3 of us designed an educational booklet, the Blood Sugar Monitoring Owner s Manual (BGMOM), 17 with the goal of improving the physical and emotional well-being of patients with diabetes by increasing adherence to BG monitoring. 689

2 218 Patients Approached for Participation Table 1. Contents of the Blood Sugar Monitoring Owner s Manual 17 5 Patients Assigned to Group 5 Patients Assigned to Group Blood Glucose Monitoring/ Health Information Survey 199 Patients Randomized Blood Glucose Monitoring/ Health Information Survey Satisfaction with Health Care Survey Baseline 3-mo Follow-up 6-mo Follow-up To evaluate the effectiveness of the BGMOM in increasing BG monitoring frequency, we conducted a 6-month, prospective randomized controlled trial with adults characterized as being at high risk (ie, hemoglobin A 1C level 8.%). By selecting this group, we had an opportunity to assess improvement during a short-term intervention. We hypothesized that exposure to diabetes education alone would be insufficient to alter monitoring behavior but that greater adherence would result from the attention to expectations and affective responses to BG results provided by the BGMOM. METHODS PARTICIPANTS 19 Patients Declined Participation 99 Patients Assigned to SC Group Blood Glucose Monitoring/ Health Information Survey Satisfaction with Health Care Survey Figure 1. Study design of randomized intervention trial. BGM indicates Blood Glucose Monitoring Owner s Manual 17 intervention;, attention control (blood glucose meter only); and SC, standard care. The 199 participants were patients at the Joslin Diabetes Center in Boston, Mass, with type 1 (35%) or type 2 (65%) diabetes. Exclusion criteria included a medical history of established renal disease (serum creatinine level 2. mg/dl [ µmol/l]), major visual impairment, myocardial infarction within the last 6 months, or major psychiatric disorder. Female patients were excluded if they were pregnant. At enrollment, participants most recent hemoglobin A 1C values were 8.% or greater. The Joslin Committee on Human Studies approved the study protocol. PROCEDURES AND MEASURES Eligible patients were contacted by mail and telephone before a regularly scheduled visit. Informed written consent was obtained at the visit, followed by randomization to 1 of 3 study groups: BGMOM intervention (BGM ), attention control (BG Your diabetes safety belt Blood sugar monitoring can help preserve your well-being Why and how you check your blood sugar When to check your blood sugar Checking your blood sugar provides positive feedback, regardless of the number Keys to success Think high and low, not good or bad Think blood check, not blood test Expect your blood sugar levels to vary, so aim for a range With your team, set realistic target ranges as your goal Your personal rules of the road Blood sugar monitoring helps you stay on the right road with your diabetes management Out-of-range blood sugar levels are common Use your energies to react appropriately Understanding potential roadblocks to monitoring Getting past the roadblocks Are you running into diabetes roadblocks? What blood sugar monitoring can do for you Information about additional resources meter only []), or standard care (SC) (Figure 1). Sequential recruitment continued until enrollment was complete. Ten percent of those contacted declined participation. The final sample was composed of 5 patients in each of the BGM and groups and 99 patients in the SC group. Each participant in the BGM and groups received a BG meter, a 3-minute diabetes education session focused on BG monitoring, and support from a certified diabetes educator (M.T.L. and K.A.C.). Patients received new meters (Accu-Chek Advantage; Roche Diagnostics, Indianapolis, Ind) but were not given glucose test strips; instead, they received prescriptions for monitoring supplies covered by health insurance as mandated by Massachusetts state law. 18 Participants in the BGM group also received the BGMOM, and the certified diabetes educator reviewed the manual during the same 3-minute session. Patients in the SC group received their usual care. Usual care encompassed individual or group standard diabetes education as accredited by the American Diabetes Association (ADA). The BGMOM is an 18-page color manual that was developed to diminish barriers to BG monitoring without significant cost or time. It targets patients with type 1 or type 2 diabetes who are receiving various therapies and provides practical information on the mechanics of BG monitoring, as well as approaches to help patients process their emotions concerning diabetes and BG monitoring (Table 1 and Figure 2). We created the manual to accommodate a middle school reading level to allow for a broad range of abilities. The manual advocates that feedback provided by monitoring be positive, regardless of the BG monitoring result. It emphasizes that monitoring is not a test but a check and that BG monitoring results are not good or bad but in range or out of range. It also provides a definition of hemoglobin A 1C and how it can be used to guide diabetes management. Study participants were followed up for 6 months. Data, collected by medical record review and surveys, included frequency of BG monitoring, hemoglobin A 1C level measurement results, knowledge of BG monitoring and hemoglobin A 1C, affect regarding BG monitoring results, and satisfaction with diabetes management and care. Baseline BG monitoring frequency was not available in the SC group. values (reference range, 4%-6%) were obtained at baseline and during follow-up. Patients in the BGM and groups completed the 69

3 Figure 2. Cover and sample page from the Blood Sugar Monitoring Owner s Manual. 17 Blood Glucose Monitoring/Health Information Survey 19 at baseline. Participants in all 3 groups completed the Blood Glucose Monitoring/Health Information Survey and the Satisfaction with Diabetes Health Care Survey at study s end. The Blood Glucose Monitoring/Health Information Survey includes questions about the patient s social situation, educational level, family and medical history, and BG monitoring frequency, as well as a short section addressing the patient s diabetes-specific knowledge and affect regarding BG monitoring. The Satisfaction with Diabetes Health Care Survey contains questions regarding the self-assessed quality of diabetes care and relationships with health care professionals. STATISTICAL ANALYSIS Statistical analyses were performed with SAS statistical software, version 8.2 for Windows (SAS Institute Inc, Cary, NC). Means ± SDs are presented unless otherwise indicated. Both univariate and multivariate analyses were performed. The primary outcome measure was frequency of BG monitoring. Secondary outcome measures included glycemic control, knowledge of hemoglobin A 1C, and affect regarding BG monitoring results. Analysis of variance, unpaired t tests, Fisher exact test, and 2 analyses were used to compare outcome measures among and between groups. Paired t tests were used to determine significant change within groups. RESULTS BASELINE CHARACTERISTICS At entry, the study population had a mean age of 49.2±13. years (range, years), a duration of diabetes of 1.7±6.2 years (range, 1-33 years), a body mass index (calculated as weight in kilograms divided by the square of height in meters) of 3.1±6.3, and a hemoglobin A 1C level of 9.1%±1.1%. For insulin-treated patients, the mean duration of insulin therapy was 7.7±5.8 years. Independent of group assignment, patients with type 1 diabetes were checking BG levels 2.4±1.3 times daily, whereas patients with type 2 diabetes were checking levels 1.6±1.2 times daily (P=.3). Glycemic control did not differ between patients with type 1 (9.%±1.1%) and type 2 diabetes (9.1%±1.1%). The 3 groups were similar with respect to age, sex, ethnicity, educational level, body mass index, type of diabetes, therapy, and duration of diabetes (Table 2). The BGM and groups had a similar frequency of daily BG monitoring at baseline (BGM : 1.9±1.3; : 1.7±1.3). The hemoglobin A 1C level was also similar between the groups, although it was slightly higher in the BGM group compared with the SC group (9.3%±1.2% vs 8.9%±.9%; P=.6). FREQUENCY OF BG MONITORING At study s end, patients in the BGM group were checking BG levels significantly more often (2.8±1.5 times daily) than patients in both the (2.±1.3 times daily; P=.1) and SC (2.1±1.7 times daily; P=.4) groups. The increase in monitoring frequency during the study was significant for the BGM group (P.1) but not for the group. In the BGM group, 98% of patients increased or maintained their frequency of BG monitoring compared with baseline. This was significantly higher 691

4 Table 2. Baseline Characteristics of Study Participants Characteristic BGM (n = 5) (n = 5) SC (n = 99) Age, mean ± SD, y 46.1 ± ± ± 13.2 Male, % BMI, mean ± SD 3.3 ± ± ± 5.8 Blood pressure, mean ± SD, mm Hg 132/77 ± /1 131/74 ± 17/8 131/75 ± 18/9 Educational level, % Grade school High school Junior college or technical training College, graduate, or professional Duration of diabetes, mean ± SD, y 9.5 ± ± ± 5.9 Type 1 diabetes mellitus, % , mean ± SD, % 9.3 ± ± ±.9 Mode of therapy, % Diet only 2 2 Oral agent(s) only Insulin only Insulin and oral agent(s) CSII (pump therapy), % Abbreviations: BGM, Blood Sugar Monitoring Owner s Manual 17 intervention; BMI, body mass index (calculated as weight in kilograms divided by the square of height in meters); CSII, continuous subcutaneous insulin infusion;, attention control (blood glucose meter only); SC, standard care. A B C Monitoring Frequency, No. of Times Daily Decreased Increased/Maintained Change in Frequency Baseline Study Completion Study Time Baseline Study Completion Study Time Figure 3. Frequency of blood glucose (BG) monitoring. A, Change in BG monitoring frequency. A significantly higher percentage of participants in the Blood Sugar Monitoring Owner s Manual 17 intervention (BGM ) group maintained or increased their monitoring frequency during the study compared with those in the attention control (BG meter only) () group (Fisher exact test; P=.2). B, Percentage of patients monitoring BG levels 4 or more times daily. The BGM group had a significantly higher percentage of patients monitoring levels 4 or more times daily at study s end than the group ( 2 1=6.41; P=.1). C, Frequency of BG monitoring among patients with type 1 diabetes mellitus. Patients with type 1 diabetes in the BGM group significantly increased their monitoring frequency, exceeding the American Diabetes Association s recommendation to check BG levels 3 times daily (P=.4). There was no significant increase among patients with type 1 diabetes in the group. than the percentage of patients in the group (79%) who increased or maintained their monitoring frequency during the study (P=.2; Figure 3). Patients in the BGM group were more than 1 times as likely as patients in the group to increase or maintain their BG monitoring frequency (odds ratio, 1.3; 95% confidence interval, ). Although BG monitoring frequency was similar between the BGM and groups at baseline, a significantly higher percentage of participants in the BGM group (35%) were checking their blood glucose levels 4 times daily or more at study s end than patients in the group (12%; P=.1; Figure 3). In the BGM group, daily frequency of BG monitoring increased significantly for patients with type 1 and type 2 diabetes. Participants with type 1 diabetes were checking BG levels 2.6±1.1 times daily at baseline and 3.5±1.3 times daily at study completion (P =.4; Figure 3). Participants with type 2 diabetes were checking BG levels 1.5±1.3 times daily at baseline and 2.3±1.4 times daily at study completion (P=.7). In the group, no significant change occurred in daily monitoring frequency for patients with type 1 (baseline: 2.1±1.6; completion: 2.5±1.7) or type 2 (baseline: 1.6±1.2; completion: 1.8±1.1) diabetes. SURVEY RESPONSES At study s end, a significant difference was observed among groups in participants ability to define hemoglobin A 1C correctly (Figure 4). A higher percentage of those in the 692

5 SC + SC Patients Accurately Defining Patients Expressing Negative Affect About Out-of-Range BG Monitoring Results No Improvement Improvement Changes in Figure 4. Definition of hemoglobin A 1C and diabetes-specific negative affect. A higher percentage of the Blood Sugar Monitoring Owner s Manual 17 intervention (BGM ) group correctly defined hemoglobin A 1C compared with the other groups ( 2 2=6.69; P=.4). A smaller percentage of the BGM group reported negative affect regarding blood glucose (BG) monitoring results than the other groups ( 2 2=6.86; P=.3). indicates attention control (blood glucose meter only); SC, standard care. BGM group (88%) was able to correctly define hemoglobin A 1C compared with those in both the (63%) and SC (75%) groups (P=.4). A significantly smaller percentage of the BGM group participants (38%) reported negative affect regarding BG monitoring results than those in either the (65%) or SC (57%) groups (P=.3; Figure 4). However, no difference in reported satisfaction with medical care was noted among the 3 groups. GLYCEMIC CONTROL At study s completion, no significant differences had occurred in glycemic control among the 3 groups (BGM : 9.3%±1.7%; : 9.1%±1.3%; SC: 9.%±1.5%), but the BGM group demonstrated the greatest improvement in hemoglobin A 1C levels (BGM :.13%±1.28%; :.4% ±1.31%; SC:.4% ±1.1%). Although no group had significantly lower hemoglobin A 1C values at study s end, a comparison of baseline and follow-up hemoglobin A 1C levels revealed that most participants in the BGM group improved their glycemic control. To examine change in glycemic control, participants were classified according to whether their control did or did not improve during the study. The and SC groups were combined because the percentage of those with improved control in each group was identical (44%). A higher percentage of those in the BGM group (61%) improved their hemoglobin A 1C level compared with the other groups combined (P=.5; Figure 5). The BGM group also had the highest percentage of participants (26%) with a hemoglobin A 1C level of 8.% or lower at study s end (: %; SC: 19%). There were no significant changes in glycemic control for patients with type 1 or type 2 diabetes in any of the groups. MULTIVARIATE ANALYSES Figure 5. Change in glycemic control from baseline to the end of the study. A higher percentage of patients in the Blood Sugar Monitoring Owner s Manual 17 intervention (BGM ) group improved their glycemic control compared with the attention control (blood glucose meter only) () and standard care (SC) groups combined ( 2 1=3.75; P=.5). In a multivariate model (R 2 =.26, P.1) controlling for age, sex, duration of diabetes, educational level, and socioeconomic status, group assignment (P=.2) was a significant predictor of BG monitoring frequency at study completion, confirming the univariate findings (Figure 6). As expected, type of diabetes was also a significant predictor in the model, with patients who had type 1 diabetes monitoring more frequently (3. times daily) than patients with type 2 diabetes (1.8 times daily). Finally, in a multivariate model (R 2 =.13) controlling for age, sex, duration of diabetes, type of diabetes, educational level, socioeconomic status, and baseline hemoglobin A 1C level, assignment to the BGM group (P=.3) was a significant predictor of improvement in glycemic control at study s end. COMMENT The ADA has estimated total health care expenditures attributable to diabetes at approximately $132 billion, with the average expenditure per patient more than twice that of the patient without diabetes. 21 A simple, inexpensive intervention such as the BGMOM, aimed at increasing frequency of BG monitoring and improving glycemic control, has the potential to benefit a greater number of patients, at a lower cost, than enrolling small numbers of patients in intensive management regimens. Participants in our study appeared to benefit from the BGMOM. Almost all who received the BGMOM either maintained or increased their BG monitoring frequency. Patients who received the BGMOM reported significantly less negative affect about elevated BG monitoring results and displayed a greater understanding of hemoglobin A 1C than patients in the other groups. Finally, patients in the BGMOM group were more likely to improve their glycemic control at study completion than the other groups. Thus, the BGMOM, a relatively simple and inexpensive tool, was associated with increased BG monitoring frequency and patient knowledge, less negative affect concerning out-ofrange BG levels, and improved glycemic control. The Diabetes Control and Complications Trial and the UK Prospective Diabetes Study support improvement of diabetes control to reduce the risk of late complica- 693

6 Monitoring Frequency, No. of Times Daily Group Figure 6. Blood glucose monitoring frequency at study completion according to group. In a significant multivariate model (R 2 =.26; P.1) controlling for age, sex, type and duration of diabetes, educational level, and socioeconomic status, group assignment (P=.2) was a significant predictor of blood glucose monitoring frequency at study completion. Data points reflect mean ± SE (error bars) for each group. BGM indicates Blood Sugar Monitoring Owner s Manual 17 intervention;, attention control (blood glucose meter only); and SC, standard care. tions More frequent BG monitoring has been associated with better glycemic control in type 1 and type 2 diabetes. Thus, an increase in monitoring frequency is one effective approach to improving glycemic control Those studies unable to support a relationship between BG monitoring frequency and hemoglobin A 1C level have been cross-sectional in nature, suggesting that patients with elevated hemoglobin A 1C levels may have only recently increased monitoring frequency. 16,25 Longitudinal studies, like the current investigation, have uncovered a strong relationship between increased BG monitoring frequency and improved hemoglobin A 1C levels. In a prospective study of 3 youth with type 1 diabetes, Levine et al 4 established BG monitoring frequency as the sole modifiable predictor of glycemic control, with more frequent monitoring significantly predicting improved hemoglobin A 1C values. Karter et al 11 found that among patients with nonpharmacologically treated type 2 diabetes, those who practiced selfmonitoring at any frequency had mean hemoglobin A 1C values that were.4% lower than patients who did no monitoring at all. In a prospective study, Murata et al 7 reported that BG monitoring improved hemoglobin A 1C values in patients with insulin-treated type 2 diabetes, especially in patients with entry values greater than 8.%. In a retrospective follow-up study, Evans et al 6 found that greater BG strip prescription redemption significantly predicted lower hemoglobin A 1C values. The ADA recommends target hemoglobin A 1C values less than 7.%. 26 To help achieve this goal, the ADA recommends that patients with type 1 diabetes mellitus monitor their BG levels at least 3 times daily. 26 For patients with type 2 diabetes treated with oral agents, optimal BG monitoring frequency is not known, but the ADA specifies that it should be sufficient to attain targeted BG levels; patients with type 2 diabetes treated with insulin need to monitor BG levels more frequently than those taking oral agents. 26 In our study, patients with type 1 diabetes SC were checking BG levels less frequently at baseline than recommended by the ADA. At study s end, however, patients with type 1 diabetes who had received the BGMOM were checking BG levels an average of 3.5 times daily, exceeding the ADA s recommendation. Participants with type 1 diabetes in the group were still checking less frequently (2.5 times daily) than recommended. Among patients with type 2 diabetes, participants who received the BGMOM significantly increased their frequency of daily monitoring to 2.3 times daily, whereas those in the group did not (1.8 times daily). Success in managing diabetes requires maintenance of the patient s self-care routine. Assisting patients in taking an informed and extensive role in the management of their diabetes is crucial to long-term success. The BGMOM helps patients by providing practical information and tools for overcoming common barriers to optimal monitoring frequency. In standard diabetes education, patients are instructed in the mechanics of BG monitoring and are often given guidelines regarding food intake, activity, and medication use for out-of-range BG monitoring results. Although cognitive and behavioral responses are taught in the clinical setting, patients emotional responses and adaptation to this uncomfortable task often go unaddressed. Negative emotions experienced by patients in response to out-of-range BG monitoring results may deter them from consistent monitoring behavior and contribute to suboptimal glycemic control. 27 Thus, although it can be difficult and time consuming for health care professionals to address barriers to BG monitoring, it is an essential component of diabetes care because studies continue to support the tight association between BG monitoring frequency and hemoglobin A 1C value outcomes. Since the Diabetes Control and Complications Trial and the UK Prospective Diabetes Study, researchers and health care professionals continue to evaluate management strategies aimed at improving glycemic control in type 1 and type 2 diabetes. No single approach has consistently yielded improved glycemic outcomes. Thus, multiple interventions are likely necessary to enhance treatment adherence and improve glycemic control. A major focus of the BGMOM addresses the inherent fluctuations of BG levels in diabetes and the attendant need to prevent self-blame and frustration from interfering with frequent BG monitoring. The BGMOM can serve as a psychoeducational tool that addresses some of the behavioral barriers to adherence while presenting BG monitoring in a straightforward and positive manner. A simple-to-use, easily distributable tool like the BGMOM can positively affect patients diabetes self-management without straining personnel or financial resources. The incorporation of a manual, such as the BGMOM, as an adjunct to regular health care visits may enhance diabetes selfcare and improve health outcomes while imposing minimal requirements of time, expense, and diabetes-specific expertise on health care professionals. Accepted for Publication: September 9, 5. Correspondence: Lori M. B. Laffel, MD, MPH, Pediatric, Adolescent, and Young Adult Section, Joslin Diabetes Center, One Joslin Place, Boston, MA 2215 (lori.laffel@joslin.harvard.edu). 694

7 Author Contributions: Dr Laffel had full access to all study data and takes responsibility for the integrity of the data and the accuracy of the data analysis. Financial Disclosure: None. Funding/Support: This study was part of an investigatorinitiated project supported by an unrestricted research grant from Roche Diagnostics to Drs Laffel and Anderson, by grants T32 DK726 and T32 DK6372 from the National Institutes of Health to Dr Moreland, and by the Charles H. Hood Foundation and the Katherine Adler Astrove Youth Education Fund (Ms Volkening). Role of the Sponsor: The funding organization was not involved in the design or conduct of the study; the collection, management, analysis, or interpretation of the data; or the preparation, review, or approval of the manuscript. Previous Presentation: Portions of this manuscript were presented at the 6th Annual Scientific Sessions of the American Diabetes Association; June 11, ; San Antonio, Tex. Additional Information: The BGMOM was written by Ms Lawlor and Drs Anderson and Laffel. Copies of the manual are available from the corresponding author. REFERENCES 1. Coates VE, Boore JR. The influence of psychological factors on the selfmanagement of insulin-dependent diabetes mellitus. J Adv Nurs. 1998;27: Chin MH, Cook S, Jin L, et al. Barriers to providing diabetes care in community health centers. Diabetes Care. 1;24: Williams GC, Zeldman A. Patient-centered diabetes self-management education. Curr Diab Rep. 2;2: Levine BS, Anderson BJ, Butler DA, Antisdel JE, Brackett J, Laffel LMB. Predictors of glycemic control and short-term adverse outcomes in youth with type 1 diabetes. J Pediatr. 1;139: Nathan DM, McKitrick C, Larkin M, Schaffran R, Singer DE. Glycemic control in diabetes mellitus: have changes in therapy made a difference? Am J Med. 1996; 1: Evans JM, Newton RW, Ruta DA, MacDonald TM, Stevenson RJ, Morris AD. 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