Holly C. Schachner

Active Assistance Technology Reduces Glycosylated Hemoglobin and Weight in Individuals With Type 2 Diabetes: Results of a Theory-Based Randomized Trial

BACKGROUND Type 2 diabetes is an individual health challenge requiring ongoing self-management. Remote patient reporting of relevant health parameters and linked automated feedback via mobile telephone have potential to strengthen self-management and improve outcomes. This research involved development and evaluation of a mobile telephone-based remote patient reporting and automated telephone feedback system, guided by health behavior change theory, aimed at improving self-management and health status in individuals with type 2 diabetes. SUBJECTS AND METHODS This research comprised a randomized controlled trial. Inclusion criteria were diagnosis of type 2 diabetes, elevated glycosylated hemoglobin (HbA1c) levels (range, 6.5-11%) or use of oral diabetes medication, and 30-70 years of age. Intervention subjects (n=24) participated in remote patient reporting of health status parameters and linked health behavior change feedback. Control participants (n=24) received standard of care including diabetes education and healthcare provider counseling. Patients were followed for approximately 10 months. RESULTS Intervention participants achieved, compared with controls and controlling for baseline, a significantly greater mean reduction in HbA1c of -0.40% (95% confidence interval [CI] -0.67% to -0.14%) versus 0.036% (95% CI -0.23% to 0.30%) (P<0.03) and significantly greater weight reduction of -2.1 kg (95% CI -3.6 to -0.6 kg) versus 0.4 kg (95% CI -1.1 to 1.9 kg). Nonsignificant trends for greater intervention compared with control improvement in systolic and diastolic blood pressure were observed. CONCLUSIONS Sophisticated information technology platforms for remote patient reporting linked with theory-based health behavior change automated feedback have potential to improve patient outcomes in type 2 diabetes and merit scaled-up research efforts.

Understanding self-monitoring of blood glucose among individuals with type 1 and type 2 diabetes: an information-motivation-behavioral skills analysis.

Purpose To evaluate self-monitoring of blood glucose (SMBG) information deficits, motivational obstacles, and behavioral skills limitations in individuals with type 1 and type 2 diabetes, and to assess the relationship of these deficits with SMBG frequency. Methods Individuals with type 1 (n = 208; 103 male, 105 female) and type 2 (n = 218; 107 male, 111 female) diabetes participated in an online survey assessing SMBG information, motivation, behavioral skills, and behavior. Results A substantial proportion of participants scored as SMBG uninformed, unmotivated, and unskilled on specific assessment items. SMBG information, motivation, and behavioral skills deficits were significantly correlated with SMBG frequency, such that individuals with type 1 or type 2 diabetes, who were less informed, less motivated, and less behaviorally skilled, reported lower frequency of SMBG. Conclusion Common and consequential SMBG information, motivation, and behavioral skills deficits were present, and patients with these gaps were less likely to test frequently. Clinical education focusing on relevant SMBG information, motivation to act, and behavioral skills for acting effectively may be a priority.

Evaluation of a novel continuous glucose measurement device in patients with diabetes mellitus across the glycemic range.

Background: This glucose clamp study assessed the performance of an electrochemical continuous glucose monitoring (CGM) system for monitoring levels of interstitial glucose. This novel system does not require use of a trocar or needle for sensor insertion. Method: Continuous glucose monitoring sensors were inserted subcutaneously into the abdominal tissue of 14 adults with type 1 or type 2 diabetes. Subjects underwent an automated glucose clamp procedure with four consecutive post-steady-state glucose plateau periods (40 min each): (a) hypoglycemic (50 mg/dl) (b) hyperglycemic (250 mg/dl), (c) second hypoglycemic (50 mg/dl), and (d) euglycemic (90 mg/dl). Plasma glucose results obtained with YSI glucose analyzers were used for sensor calibration. Accuracy was assessed retrospectively for plateau periods and transition states, when glucose levels were changing rapidly (approximately 2 mg/dl/min). Results: Mean absolute percent difference (APD) was lowest during hypoglycemic plateaus (11.68%, 14.15%) and the euglycemic-to-hypoglycemic transition (14.21%). Mean APD during the hyperglycemic plateau was 17.11%; mean APDs were 18.12% and 19.25% during the hypoglycemic-to-hyperglycemic and hyperglycemic-to-hypoglycemic transitions, respectively. Parkes (consensus) error grid analysis (EGA) and rate EGA of the plateaus and transition periods, respectively, yielded 86.8% and 68.6% accurate results (zone A) and 12.1% and 20.0% benign errors (zone B). Continuous EGA yielded 88.5%, 75.4%, and 79.3% accurate results and 8.3%, 14.3%, and 2.4% benign errors for the euglycemic, hyperglycemic, and hypoglycemic transition periods, respectively. Adverse events were mild and unlikely to be device related. Conclusion: This novel CGM system was safe and accurate across the clinically relevant glucose range.

What Primary Care Providers Can Do to Address Barriers to Self-Monitoring of Blood Glucose

S elf-monitoring of blood glucose (SMBG) can be instrumental in achieving glycemic control in individuals with type 11,2 or type 23–8 diabetes. SMBG can help people with diabetes understand the effects of food and exercise on blood glucose and assist them to make healthy choices; provide insights to patients and clinicians concerning the effectiveness of therapies; and provide direction in efforts to achieve and maintain glycemic control.5,9–11 SMBG will be most effective in improving glycemic control among individuals with diabetes who have learned appropriate self-management actions to take on the basis of SMBG results and who undertake such actions consistently.2,5 Despite the substantial potential benefits of SMBG, however, adherence to recommended frequency and patterns of self-monitoring is suboptimal and inconsistent among many individuals with diabetes.5,9–11 A fundamental goal of the clinical management of diabetes involves facilitating diabetes self-care practices that lead to positive health outcomes.12 SMBG is seen as a tool that can provide useful information to patients and health care providers (HCPs), assisting patients to become active self-managers and HCPs to make timely and informed treatment adjustments to optimize therapy and improve metabolic outcomes.13 The International Diabetes Federation supports this concept in the first recommendation of its Guideline on Self-Monitoring of Blood Glucose in Non–Insulin-Treated Type 2 Diabetes, which states, “SMBG should be used only when individuals with diabetes (and/or their caregivers) and/or their HCPs have the knowledge, skills, and willingness to incorporate SMBG monitoring and therapy adjustment into their diabetes care plan in order to attain agreed treatment goals.”14 The aim of SMBG is to facilitate timely clinical interventions to achieve or maintain blood glucose within an acceptable target range and to assist individuals with diabetes …

Performance of a New Blood Glucose Monitoring System in the Hands of Intended Users

BACKGROUND This study assessed the performance of a blood glucose monitoring system (BGMS) in development that uses a new generation of blood glucose test strips with capillary and venous blood in the hands of its intended users, people with diabetes and healthcare professionals (HCPs). SUBJECTS AND METHODS In total, 93 subjects ≥ 18 years old (median age, 33 years) with type 1 (78%) or type 2 (22%) diabetes participated. Untrained subjects performed self-test fingersticks using a Microlet(®)2 lancing device (Bayer HealthCare LLC, Diabetes Care, Tarrytown, NY) followed by testing of their own capillary blood on the BGMS. HCPs performed fingersticks (using a Tenderlett(®) lancing device [International Technidyne Corp., Edison, NJ]) and venipunctures on subjects and tested both capillary and venous samples from subjects on the BGMS. All BGMS results were compared with Yellow Springs Instruments (YSI) (YSI Life Sciences, Inc., Yellow Springs, OH) laboratory results. Analytical accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., within ± 15 mg/dL or ± 20% of the YSI results for samples with glucose concentrations < 75 mg/dL and ≥ 75 mg/dL, respectively) and more stringent criteria (i.e., within ± 15 mg/dL or ± 15% of the YSI results for samples with glucose concentrations < 100 mg/dL and ≥ 100 mg/dL, respectively). RESULTS Overall, 98.9% (180/182) of subject Microlet2 capillary fingerstick results, 99.5% (182/183) of HCP Tenderlett capillary fingerstick results, and 100% (186/186) of venous results met current ISO criteria and more stringent criteria. The average hematocrit was 44%, with values ranging from 32% to 52%. CONCLUSIONS Test results from both capillary fingerstick and venous samples with a new BGMS in development met current accuracy guidelines as well as proposed tighter criteria.

Re-evaluating a standard approach to assessing glucose monitor performance.

Mahoney and Ellison reviewed 52 articles published between 2002 and 2006 on handheld blood glucose monitor performance. They concluded that multiple guidelines for study design, methodology, and reporting exist but are often not adhered to, a fact that affected both the quality of some studies and the conclusions drawn from them. They proposed that the unavailability of guidelines from a single source contributed to this situation. In a second publication, these same authors proposed a 14point checklist based on a number of published guidelines with the intent that this list be a mandatory, single source for the design and reporting of handheld blood glucose monitor evaluations. While we appreciate these efforts and agree with the spirit of the attempt to standardize and raise the quality of blood glucose monitor evaluations in general, we have concerns regarding several issues. In general, our concerns include:

Testing versus guessing blood glucose values: impact on self-care behaviors in type 2 diabetes

Abstract Objective: To assess differences between estimated blood glucose values and those measured on a blood glucose meter and the impact on self-care behavior in type 2 diabetes. Research design and methods: Subjects ≥18 years with type 2 diabetes (N = 297) attending a Taking Control of Your Diabetes conference were asked questions about diabetes management and to estimate their current blood glucose. Study staff tested subjects’ blood glucose on a meter. After seeing the result, subjects were again asked questions on diabetes management. Clinical trial registration: NCT01453413. Main outcome measure: The percentage of subject blood glucose estimations that were outside ISO 15197:2003 accuracy criteria (>±15 mg/dL or >±20% of meter glucose values). Results: Nearly half (46%) of subjects estimated blood glucose values outside ISO 15197:2003 accuracy criteria. Time since last blood glucose test, time since last meal, testing frequency, and A1C did not have an effect on differences between estimated blood glucose values and meter results. In the questionnaire before blood glucose testing, most subjects strongly agreed, agreed, or neither agreed nor disagreed that ‘I make decisions about my diabetes, such as my food intake or my insulin dose even when I do not test my blood sugar’ (71%) and ‘My body tells me without testing if my blood sugar is low or high’ (77%). After blood glucose testing, 99% of subjects strongly agreed, agreed, or neither agreed nor disagreed that ‘Knowing my blood sugar by checking could help me make different diabetes decisions’. Conclusions: Self-monitoring of blood glucose is an important component of diabetes self-management. Testing rather than guessing blood glucose values is important to obtain accurate results and inform people with type 2 diabetes to make effective, appropriate diabetes management decisions. A potential limitation of this study is that the subject population may not be representative of the general population of people with diabetes; however, the conference setting may attract a more motivated population, which could underestimate the magnitude of the results.

Performance evaluation and labeling comprehension of a new blood glucose monitoring system with integrated information management.

Background: This study evaluated performance and product labeling of CONTOUR® USB, a new blood glucose monitoring system (BGMS) with integrated diabetes management software and a universal serial bus (USB) port, in the hands of untrained lay users and health care professionals (HCPs). Method: Subjects and HCPs tested subjects finger stick capillary blood in parallel using CONTOUR USB meters; deep finger stick blood was tested on a Yellow Springs Instruments (YSI) glucose analyzer for reference. Duplicate results by both subjects and HCPs were obtained to assess system precision. System accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines [within ±15 mg/dl of mean YSI results (samples <75 mg/dl) and ±20% (samples ≥75 mg/dl)]. Clinical accuracy was determined by Parkes error grid analysis. Subject labeling comprehension was assessed by HCP ratings of subject proficiency. Key system features and ease-of-use were evaluated by subject questionnaires. Results: All subjects who completed the study (N = 74) successfully performed blood glucose measurements, connected the meter to a laptop computer, and used key features of the system. The system was accurate; 98.6% (146/148) of subject results and 96.6% (143/148) of HCP results exceeded ISO 15197:2003 criteria. All subject and HCP results were clinically accurate (97.3%; zone A) or associated with benign errors (2.7%; zone B). The majority of subjects rated features of the BGMS as “very good” or “excellent.” Conclusions: CONTOUR USB exceeded ISO 15197:2003 system performance criteria in the hands of untrained lay users. Subjects understood the product labeling, found the system easy to use, and successfully performed blood glucose testing.

Performance of the DIDGET Blood Glucose Monitoring System in Children, Teens, and Young Adults

Background: This study evaluated the performance of the DIDGET® blood glucose monitoring system (BGMS) in the hands of its intended users: Children, teens, and young adults with diabetes. Methods: Finger stick capillary blood samples were tested in duplicate by subjects (with parent/guardian assistance, if needed) and health care professionals using the DIDGET BGMS, and results were compared with those obtained using a Yellow Springs Instruments (YSI) glucose analyzer. Modified venous blood samples (i.e., glycolyzed or spiked with glucose) were used to analyze meter performance under extreme glucose concentrations. Accuracy was assessed using International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., 95% of meter results within ±15 mg/dl or ±20% of reference values). Results: A total of 123 subjects aged 4 to 24 years with type 1 or type 2 diabetes were enrolled. The DIDGET meter achieved accuracy according to ISO 15197:2003 criteria: >97% of meter results were within ±15 mg/dl or ±20% of reference values. Regression analyses showed a high degree of correlation between meter and YSI results: Coefficient of determination (R 2) = 98.2% for all samples combined and 97.2% for capillary samples only. Clinical accuracy for combined samples was demonstrated by Parkes consensus error grid analyses; 100% of meter results were in zone A (98.5%) or zone B (1.5%). There was no difference in performance or accuracy across age subsets. Hematocrit values did not affect meter blood glucose results. Conclusion: The DIDGET BGMS provided accurate test results across all age ranges in children, teens, and young adults with diabetes.