Penny Wise and Pound Foolish: Will Shortsighted Cost Reduction Measures Compromise Patient Access to Promising Self-Monitoring of Blood Glucose Technology?

In this issue of Journal of Diabetes Science and Technology, Grady and coauthors enrolled 101 patients with type 1 and type 2 diabetes to evaluate new technology incorporated into the LifeScan VerioPro and VerioIQ blood glucose meters. The “pattern detection” software provides real-time, onscreen messages that alert users to patterns of high glucose (fasting and premeal) and low glucose as they are detected. The study showed that most participants possess a good understanding of the factors that can cause hyperglycemia; however, their understanding of the causes of hypoglycemia events was not as strong. Nevertheless, more than 70% of participants indicated they preferred to use a blood glucose meter that provides pattern detection capability. Although not designed to assess the impact of the pattern detection tool on clinical outcomes, the study highlights the value of continuous innovation in self-monitoring of blood glucose (SMBG) technology among manufacturers. Unfortunately, many patients may never have access to these systems due to reductions in Medicare reimbursement. Instead, they may be forced to use SMBG systems that are inaccurate and provide inadequate patient support. Stronger regulatory requirements are needed to ensure that all SMBG systems marketed to patients are accurate, reliable, and supported by adequate patient training, and current health care reimbursement policies should be restructured to encourage manufacturers to continue their efforts to develop innovative technology to further improve the utility and usability of their SMBG systems.     

艾塞那肽替代胰岛素治疗2型糖尿病患者的临床分析

目的 总结应用艾塞那肽成功替代胰岛素治疗的2型糖尿病患者的临床特点,并比较胰岛素和艾塞那肽的降糖效果以及对血糖稳定性的影响.方法 回顾分析了成功应用艾塞那肽替代胰岛素治疗的21例2型糖尿病患者的临床资料和自我血糖监测记录,应用配对t检验对患者先后应用胰岛素和艾塞那肽治疗期间的血糖值进行比较分析.结果 患者多为中青年,糖尿病病程短,体型肥胖,平均糖化血红蛋白为(9.9±3.0)%,空腹C肽为(0.43±0.13)pmol/ml,餐后2 h C肽为(1.08±0.66)pmol/ml.应用艾塞那肽期间,患者血糖水平和达标率明显优于胰岛素治疗期间的血糖(P＜0.01),同时全天血糖标准差、最大血糖波动幅度、四分位血糖波动范围、餐后血糖波动幅度、空腹血糖变异系数和日间血糖平均绝对差均明显低于胰岛素治疗期间的血糖波动情况(P＜0.05).回归分析结果显示血糖波动性指标主要与餐后血糖呈正相关,与空腹血糖无关.结论 胰岛功能轻度受损的肥胖2型糖尿病患者应用艾塞那肽不仅可以良好地控制血糖,而且能够减少血糖的波动性.     

Pharmaceutical care of patients with gestational diabetes mellitus

Rationale, aims and objective To investigate whether the introduction of a programme of optimising drug treatment, intensive education and self‐monitoring of patients diagnosed with gestational diabetes mellitus (GDM) at an early stage (<20 gestational weeks), will improve management outcomes as determined by objective measures of patient knowledge about diabetes, glycaemia control, maternal/neonatal complications, and health‐related quality of life. Methods The study was a randomized, controlled, longitudinal, prospective clinical trial performed at Al‐Ain Hospital, Al‐Ain, United Arab Emirates. Over an 18‐month period, patients diagnosed with GDM were recruited and were randomly assigned to either an intervention or a control group, in a ratio of 3:2. Intervention patients received a structured pharmaceutical care service (including education and introduction of intensive self‐monitoring) while control patients received traditional services. Patients were followed up from time of recruitment until 6 months postnatally at scheduled outpatient clinics. A range of clinical and humanistic outcome measures, including maternal and neonatal complications, were used to assess the impact of the intervention. Results A total of 165 patients (99 intervention, 66 control) completed the study. The intervention patients exhibited a range of benefits from the provision of the programme when compared with control group patients. Statistically significant (P < 0.05) improvements were shown in the intervention group for knowledge of diabetes, health‐related quality of life (as determined by the SF36), control of plasma glucose and HbA_1c, maternal complications [e.g. decreased incidence of pre‐eclampsia (5.1% vs. 16.7%), eclampsia (1.0% vs. 7.6%), episodes of severe hyperglycaemia (3.0% vs. 19.7%) and need for Caesarean section (7.1% vs. 18.2%)], and neonatal complications [e.g. decreased incidence of neonatal hypoglycaemia (2.0% vs. 10.6%), respiratory distress at birth (4.0% vs. 15.2%), hyperbilirubinaemia (1.0% vs. 12.1%) and large for gestational age (9.0% vs. 22.7%)]. Conclusion The research provides clear evidence that provision of pharmaceutical care adds value to the management of GDM as exemplified by improved maternal and neonatal outcomes.     

Individualized assessment and treatment program for alcohol dependence: results of an initial study to train coping skills

Aims Cognitive–behavioral treatments (CBT) are among the most popular interventions offered for alcohol and other substance use disorders, but it is not clear how they achieve their effects. CBT is purported to exert its beneficial effects by altering coping skills, but data supporting coping changes as the mechanism of action are mixed. The purpose of this pilot study was to test a treatment in which coping skills were trained in a highly individualized way, allowing us to determine if such training would result in an effective treatment. Design Participants were assigned randomly to a comprehensive packaged CBT program (PCBT), or to an individualized assessment and treatment program (IATP). The IATP program employed experience sampling via cellphone to assess coping skills prior to treatment, and provided therapists with a detailed understanding of patients' coping strengths and deficits. Setting Out‐patient treatment. Participants A total of 110 alcohol‐dependent men and women. Measurements Participants in both conditions completed experience sampling of situations, drinking and coping efforts prior to, and following, 12 weeks of treatment. Time‐line follow‐back procedures were also used to record drinking at baseline and post‐treatment. Findings IATP yielded higher proportion of days abstinent (PDA) at post‐treatment (P < 0.05) than did PCBT, and equivalent heavy drinking days. IATP also elicited more momentary coping responses and less drinking in high‐risk situations, as recorded by experience sampling at post‐treatment. Post‐treatment coping response rates were associated with decreases in drinking. Conclusions The IATP approach was more successful than PCBT at training adaptive coping responses for use in situations presenting a high risk for drinking. The highly individualized IATP approach may prove to be an effective treatment strategy for alcohol‐dependent patients.     

Estimating average glucose levels from glycated albumin in patients with end-stage renal disease

Purpose

In patients with diabetic end stage renal disease (ESRD), glycated albumin (GA) reflects recent glycemic control more accurately than glycated hemoglobin (HbA_1c). We evaluated the relationship between GA and average blood glucose (AG) level and developed an estimating equation for translating GA values into easier-to-understand AG levels.

Materials and Methods

A total of 185 ESRD patients, including 154 diabetic and 31 non-diabetic participants, were enrolled (108 hemodialysis, 77 peritoneal dialysis). Patients were asked to perform four-point daily self-monitoring of capillary blood glucose (SMBG) at least three consecutive days each week for four weeks. Serum levels of GA, HbA_1c and other biochemical parameters were checked at baseline, as well as at 4 and 8 weeks.

Results

Approximately 74.3±7.0 SMBG readings were obtained from each participant and mean AG was 169.1±48.2 mg/dL. The correlation coefficient between serum GA and AG levels (r=0.70, p<0.001) was higher than that of HbA_1c and AG (r=0.54, p<0.001). Linear regression analysis yielded the following equation: estimated AG (eAG) (mg/dL)=4.71×GA%+73.35, and with this formula, serum GA levels could be easily translated to eAG levels. Multivariate analysis revealed significant contributions of postprandial hyperglycemia (β=0.25, p=0.03) and serum albumin (β=0.17, p=0.04) in determining serum GA level, independent to other clinical parameters.

Conclusion

Compared to HbA_1c, serum GA levels were better correlated with AG levels. Using the estimating equation, an average blood glucose level of 155-160 mg/dL could be matched to a GA value of 18-19% in patients with ESRD.     

Effects of demand for performance,self-monitoring of arousal,and increased sympathetic nervous system activity on male erectile response

Clinical programs for the treatment of impotence generally have been successful but without experimental verification of their individual components or factors associated with the development of impotence. Twenty-four normal males participated in an investigation comparing factors believed to inhibit or facilitate penile tumescence. The effects of demand for performance, self-monitoring of erection, and increased SNS activity, were evaluated. Subjects were exposed to sexual stimuli under these conditions and measurements of penile responses were taken. Results indicated that there were no differential effects on penile responses between demand and no-demand or between self-monitoring and no self-monitoring. Increased SNS activity appeared to facilitate loss of erection, but only after, and not during, the sexual stimulus. The clinical and theoretical implications of these findings are discussed, and suggestions are made for future research.     

Performance of a New Meter Designed for Assisted Monitoring of Blood Glucose and Point-of-Care Testing

Background

Blood glucose (BG) meters used for assisted monitoring of blood glucose (AMBG) require different attributes compared with meters designed for home use. These include safety considerations (i.e., minimized risk of blood-borne pathogen transmission), capability for testing multiple blood sample types, and enhanced performance specifications. The OneTouch^® Verio™Pro+ BG meter is designed to incorporate all of these attributes.

Methods

Meter accuracy was assessed in clinical studies with arterial, venous, and capillary blood samples with a hematocrit range of 22.9–59.8%. The effect of interferents, including anticoagulants, on accuracy was evaluated. The meter disinfection protocol was validated, and instructions for use and user acceptance of the system were assessed.

Results

A total of 97% (549/566) of BG measures from all blood sample types and 95.5% (191/200) of arterial blood samples were within ±12 mg/dl or 12.5% of reference measurements. The system was unaffected by 4 anticoagulants and 57 of 59 endogenous and exogenous compounds; it was affected by 2 compounds: pralidoxime iodide and xylose. Bleach wipes were sufficient to disinfect the meter. Users felt that the meter''s quality control (QC) prompts would help them to comply with regulatory requirements.

Conclusions

The meter provided accurate measurements of different blood samples over a wide hematocrit range and was not affected by 57 physiologic and therapeutic compounds. The QC prompts and specific infection-mitigating design further aid to make this meter system practical for AMBG in care facilities.     

糖尿病患者自我血糖监测现状调查

目的了解糖尿病患者自我血糖监测的相关知识认知情况及血糖自我监测现状,为进一步开展糖尿病教育、加强糖尿病患者自我管理提供依据。方法采用问卷调查法对500例糖尿病患者就自我血糖监测相关知识的掌握情况和血糖监测状况进行调查,发放问卷500份,收回有效问卷485份。结果79．8％的患者对血糖监测重要性认识不足,73．6％不了解血糖控制的目标;44.3％患者没有进行自我血糖监测,原因包括因经济问题不愿使用血糖仪、不会使用血糖仪等;55．7％患者进行自我血糖监测,其中半数以上患者对血糖监测方法未正确掌握,62．2％对血糖监测的时间和频率缺乏认识。结论糖尿病患者自我监测血糖现状不乐观,且监测血糖相关知识缺乏。应加强对糖尿病患者自我血糖监测知识宣教,提高糖尿病患者对血糖监测重要性的认识,加强对糖尿病患者自我血糖监测技术上指导,提高糖尿病患者的自我管理意识和能力。     

Women’s experience with receiving advice on diet and Self-Monitoring of blood glucose for gestational diabetes mellitus: a qualitative study

ObjectiveWe aimed to explore how women with gestational diabetes mellitus (GDM) experience advice about diet and self-monitoring of blood glucose received in primary health care (PHC) and secondary health care (SHC) with a focus on how women perceived the care coordination and collaboration between healthcare professionals.Design, setting and subjectsIndividual interviews were conducted with 12 pregnant women diagnosed with GDM. Six women had immigrant backgrounds, and six were ethnic Norwegian. Women received GDM care in the area of Oslo, Norway. Interviews were analysed using thematic analysis.ResultsWomen described feeling shocked when they were diagnosed with GDM and feeling an immediate need for information about the consequences and management of GDM. Most of the women felt that their general practitioner (GP) had too little knowledge about GDM. Women with an immigrant background felt that the PHC midwives provided them with sufficient dietary advice related to GDM. Ethnic Norwegian women appreciated receiving more individually tailored dietary advice in SHC. Self-monitoring of blood glucose influenced women’s daily lives; however, they perceived the training in PHC and SHC as adequate. The women experienced poor collaboration between healthcare professionals in PHC and SHC, which implied that they sometimes had to initiate follow-up steps in their GDM care by themselves.ConclusionsIdeally, women diagnosed with GDM should meet healthcare professionals with sufficient knowledge about GDM as soon as possible after being diagnosed. The collaboration between healthcare professionals involved in the care of women with GDM should be improved to avoid having women feel that they need to coordinate their own care.

KEY POINTS

• Current awareness
• •The management of gestational diabetes mellitus requires appropriate follow-up by healthcare professionals
• Main statements
• •Pregnant women’s need for information about the consequences and management of gestational diabetes mellitus was highest immediately after diagnosis
• •Women perceived that they received more individually tailored information about diet and self-monitoring of blood glucose in secondary health care compared to primary health care
• •Women felt that general practitioners had insufficient knowledge about gestational diabetes mellitus
• •Based on our results, care coordination and collaboration between healthcare professionals involved in the care of women with gestational diabetes mellitus should be improved

     

Value of Self-Monitoring Blood Glucose Pattern Analysis in Improving Diabetes Outcomes

Self-monitoring of blood glucose (SMBG) is an important adjunct to hemoglobin A1c (HbA1c) testing. This action can distinguish between fasting, preprandial, and postprandial hyperglycemia; detect glycemic excursions; identify and monitor resolution of hypoglycemia; and provide immediate feedback to patients about the effect of food choices, activity, and medication on glycemic control.Pattern analysis is a systematic approach to identifying glycemic patterns within SMBG data and then taking appropriate action based upon those results. The use of pattern analysis involves: (1) establishing pre- and postprandial glucose targets; (2) obtaining data on glucose levels, carbohydrate intake, medication administration (type, dosages, timing), activity levels and physical/emotional stress; (3) analyzing data to identify patterns of glycemic excursions, assessing any influential factors, and implementing appropriate action(s); and (4) performing ongoing SMBG to assess the impact of any therapeutic changes made.Computer-based and paper-based data collection and management tools can be developed to perform pattern analysis for identifying patterns in SMBG data. This approach to interpreting SMBG data facilitates rational therapeutic adjustments in response to this information. Pattern analysis of SMBG data can be of equal or greater value than measurement of HbA1c levels.