Journal of Diabetes Science and Technology

Intradermal (ID) delivery has been shown to accelerate insulin pharmacokinetics (PK). We compared the PK and pharmacodynamic (PD) effects of insulin lispro administered before two daily standardized solid mixed meals (breakfast and lunch), using microneedle-based ID or traditional subcutaneous (SC) delivery.

The study included 22 subjects with type 1 diabetes in an eight-arm full crossover block design. One arm established each subject's optimal meal dose. In six additional arms, the optimal, higher, and lower doses (+30%, −30%) were each given ID and SC delivery, in random order. The final arm assessed earlier timing for the ID optimal dose (−12 versus −2 min). The PK/PD data were collected for 6 h following meals. Intravenous basal regular insulin was given throughout, and premeal blood glucose (BG) adjusted to 115 mg/dl.

The primary end point, postprandial time in range (70–180 mg/dl), showed no route-based differences with a high level of overall BG control for both SC and ID delivery. Secondary insulin PK end points showed more rapid ID availability versus SC across doses and meals (ΔTmax −16 min, ΔT50rising −7 min, ΔT50falling −30 min, all p < .05). Both intrasubject and intersubject variability for ID Tmax were significantly lower. Intradermal delivery showed modest, statistically significant secondary PD differences across doses and meals, generally within 90–120 min postprandially (Δ12 mg/dl BG at 90 min, Δ7 mg/dl BGmax, Δ7 mg/dl mean BG 0–2 h, all p < .05).

This study indicates that ID insulin delivery is superior to SC delivery in speed of systemic availability and PK consistency and may improve postprandial glucose control.

In order to enhance the absorption of insulin following subcutaneous injection, excipients were selected to hasten the dissociation rate of insulin hexamers and reduce their tendency to reassociate postinjection. A novel formulation of recombinant human insulin containing citrate and disodium ethylenediaminetetraacetic acid (EDTA) has been tested in clinic and has a very rapid onset of action in patients with diabetes. In order to understand the basis for the rapid insulin absorption, in vitro experiments using analytical ultracentrifugation, protein charge assessment, and light scattering have been performed with this novel human insulin formulation and compared with a commercially available insulin formulation [regular human insulin (RHI)].

Analytical ultracentrifugation and dynamic light scattering were used to infer the relative distributions of insulin monomers, dimers, and hexamers in the formulations. Electrical resistance of the insulin solutions characterized the overall net surface charge on the insulin complexes in solution.

The results of these experiments demonstrate that the zinc chelating (disodium EDTA) and charge-masking (citrate) excipients used in the formulation changed the properties of RHI in solution, making it dissociate more rapidly into smaller, charge-masked monomer/dimer units, which are twice as rapidly absorbed following subcutaneous injection than RHI (Tmax 60 ± 43 versus 120 ± 70 min).

The combination of rapid dissociation of insulin hexamers upon dilution due to the zinc chelating effects of disodium EDTA followed by the inhibition of insulin monomer/dimer reassociation due to the charge-masking effects of citrate provides the basis for the ultra-rapid absorption of this novel insulin formulation.

Exergames (i.e., video games that require gross motor activity) may provide intrinsically motivating experiences that engage youth in sustained physical activity.

Thirty-one low-income 15– to 19-year-old overweight and obese African American adolescents were randomly assigned to a competitive exergame (n = 17) or a cooperative exergame (n = 14) condition. Participants played a preassigned Wii Active exergame routine that took between 30 and 60 min each school day, and sessions occurred during lunch time or an after-school program over a 6 month period. Participation was voluntary, so students decided whether to come or not on a given day. Cooperative exergame players worked together with a peer to expend calories and earn points, while competitive exergame players competed individually against a peer to expend calories and earn points. Motivation was measured through surveys and interviews at the end of the intervention, and energy expenditure was measured by accelerometry during game play.

Compared with the competitive group, the cooperative players were significantly more intrinsically motivated to play (p = .034, partial eta-squared = 0.366) and more psychologically attracted to the design of the exergame (p = .034, partial eta-squared = 0.320). Intrinsic motivation was significantly positively correlated with energy expenditure during game play: Individuals who were motivated by control/choice had higher energy expenditure (p = .026), and those who were more goal motivated (p = .004) and more immersed in game play (p = .024) had lower energy expenditure during game play.

Cooperative exergame play produced higher intrinsic motivation to play the exergame than competitive exergame play did. Intrinsic motivation that came from a desire for control/choice was related to higher energy expenditure during game play. Cooperative exergame play holds promise as a method for engaging overweight and obese youth in physical activity.

Physical inactivity is associated with obesity and type 2 diabetes. A key obstacle to physical activity is lack of motivation. Although some interactive exercise games (i.e., exergames—video games that require physical exertion in order to play) motivate players to exercise more, few games take advantage of group dynamics to motivate players' duration of exercise. In a test of the Kohler motivation gain effect, this study varied the ability level of a virtually presented partner in an interactive exergame that focused on abdominal strength to identify effects on a subject's (S') persistence with the task.

Male (n = 63) and female (n = 72) undergraduate students were randomly assigned to one of four conditions (individual control or low-, moderate-, or high- partner discrepancy) in a conditions x gender factorial design and tested on a series of isometric abdominal exercises using PlayStation 2 EyeToy: Kinetic software. They performed the first series of five exercises alone (trial block 1), and after a rest period, those in the partner conditions performed remaining trials (trial block 2) with a same-sex virtually presented partner whom they could observe during their performance, while those in the individual control condition performed the remaining trials alone. In the partner conditions, the partner's performance was manipulated to be always better than the S's, the exact difference depending on the discrepancy condition. The partnered tasks were conjunctive; that is, success in the game depended on the performance of the weaker team member. Persistence, the outcome measure for this study, consisted of the total number of seconds the S held the exercise position.

Using planned orthogonal contrasts on difference scores between blocks 1 and 2, results showed that persistence was significantly (p < .001) greater in all experimental conditions with a virtually presented partner (M = 33.59 s) than in the individual control condition (M = −49.04 s). Subjects demonstrated more persistence in the moderate-discrepancy condition (M = 51.36 s) than in the low-discrepancy condition (M = 22.52 s) or the high-discrepancy condition (M = 26.89 s). A significant quadratic trend confirmed the expected inverted-U function relating partner discrepancy and persistence (p = .025). Although Ss persisted longer and had higher heart rate in partnered conditions, they did not perceive their exertion to be any higher than those in the individual condition.

Virtually presented partners who are moderately more capable than participants are the most effective at improving persistence in exergame tasks.

This quasi-experimental study investigated a game intervention—specifically, an alternate reality game (ARG)—as a means to influence college students' physical activity (PA). An ARG is an interactive narrative that takes place in the real world and uses multiple media to reveal a story.

Three sections of a college health course (n = 115 freshman students) were assigned either to a game group that played the ARG or to a comparison group that learned how to use exercise equipment in weekly laboratory sessions. Pre- and post-intervention measures included weight, waist circumference, body mass index (BMI), percentage body fat (PBF), and self-reported moderate physical activity (MPA) and vigorous physical activity (VPA), and PA (steps/week).

A significant group x time interaction (p = .001) was detected for PA, with a significant increase in PA for the game (p < .001) versus a significant decrease (p = .001) for the comparison group. Significant within-group increases for weight (p = .001), BMI (p = .001), and PBF (p = .001) were detected. A significant group x time interaction (p = .001) was detected when analyzing self-reported VPA, with both groups reporting decreases in VPA over time; however, the decrease was only significant for the comparison group (p < .001). No significant group differences were found for MPA.

It is important that any intervention meet the needs and interests of its target population. Here, the ARG was designed in light of the learning preferences of today's college students—collaborative and social, experiential and media-rich. Our results provide preliminary evidence that a game intervention can positively influence PA within the college student population.

Some active video games have been found to promote physical activity adherence because of enjoyment. However, many active games are exercise themed, which may interfere with the distracting properties that make game-based exercise more enjoyable than traditional exercise. This study compared exercise-themed and game-themed active games to investigate differences in energy expenditure and enjoyment.

Young adults (N = 100, 50 female, 55 overweight, aged 18–35 years) played two of four Wii Fit games (one aerobic game and one balance game per person) for 10 min each. Of the two aerobic games, one was exercise themed (jogging) and the other was game themed (hula hooping). Both balance games were game themed. Energy expenditure and enjoyment were measured.

After adjustment for gender and weight, aerobic games produced 2.70 kcal/kg⁻¹/h⁻¹ (95% confidence interval 2.41, 3.00) greater energy expenditure than balance games (p < .001), but balance games were more enjoyable (p < .001). In aerobic games, jogging produced greater energy expenditure than hula hooping in normal-weight and male participants (p < .001); in overweight and female participants, no differences were found (p > .17). Hula hooping was enjoyed more than jogging (p = .008). Enjoyment predicted energy expenditure in aerobic games (B = 0.767, p = .010).

Aerobic games produced greater energy expenditure but lower enjoyment than balance games, and a game-themed aerobic game was found more enjoyable than an exercise-themed aerobic game. Integrating more strenuous activity into entertaining games instead of games that simply simulate exercise may be a fruitful avenue for active game development.

This quasi-experimental exploratory study investigated neuropsychological effects of exercise among older adults with diabetes mellitus (DM) compared with adults without diabetes (non-DM), and it examined the feasibility of using a stationary bike exergame as a form of exercise for older adults with and without diabetes. It is a secondary analysis that uses a small dataset from a larger randomized clinical trial (RCT) called the Cybercycle Study, which compared cognitive and physiological effects of traditional stationary cycling versus cybercycling.

In the RCT and the secondary analysis, older adults living in eight independent living retirement facilities in the state of New York were enrolled in the study and assigned to exercise five times per week for 45 min per session (two times per week was considered acceptable for retention in the study) by using a stationary bicycle over the course of 3 months. They were randomly assigned to use either a standard stationary bicycle or a “cybercycle” with a video screen that displayed virtual terrains, virtual tours, and racing games with virtual competitors. For this secondary analysis, participants in the RCT who had type 2 DM (n = 10) were compared with age-matched non-DM exercisers (n = 10). The relationship between exercise and executive function (i.e., Color Trials 2, Digit Span Backwards, and Stroop C tests) was examined for DM and non-DM patients.

Older adults with and without diabetes were able to use cybercycles successfully and complete the study, so the feasibility of this form of exercise for this population was supported. However, in contrast with the larger RCT, this small subset did not demonstrate statistically significant differences in executive function between the participants who used cybercycles and those who used stationary bikes with no games or virtual content on a video screen. Therefore, the study combined the two groups and called them “exercisers” and compared cognitive outcomes for DM versus non-DM patients. As predicted, exercisers with DM exhibited significant gains in executive function as measured by the Color Trails 2 test, controlling for age and education, while non-DM exercisers did not significantly gain in this measure [group x time interaction, F(1,16]) = 9.75; p = .007].

These preliminary results support the growing literature that finds that exercise may improve cognition among older adult with DM. Additional research is needed to clarify why certain aspects of executive function might be differentially affected. The current findings may encourage physicians to prescribe exercise for diabetes management and may help motivate DM patients' compliance for engaging in physical activity.

The risk of acute hepatitis B among adults with diabetes mellitus is unknown. We investigated the association between diagnosed diabetes and acute hepatitis B.

Confirmed acute hepatitis B cases were reported in 2009–2010 to eight Emerging Infections Program (EIP) sites; diagnosed diabetes status was determined. Behavioral Risk Factor Surveillance System respondents residing in EIP sites comprised the comparison group. Odds ratios (ORs) comparing acute hepatitis B among adults with diagnosed diabetes versus without diagnosed diabetes were determined by multivariate logistic regression, adjusting for age, sex, and race/ethnicity, and stratified by the presence or absence of risk behaviors for hepatitis B virus (HBV) infection.

During 2009–2010, EIP sites reported 865 eligible acute hepatitis B cases among persons aged ≥23 years; 95 (11.0%) had diagnosed diabetes. Comparison group diabetes prevalence was 9.1%. Among adults without hepatitis B risk behaviors and with reported diabetes status, the OR for acute hepatitis B comparing adults with and without diabetes was 1.9 (95% confidence interval [CI] = 1.4, 2.6); ORs for adults ages 23–59 and ≥60 years were 2.1 (95% CI = 1.6, 2.8) and 1.5 (95% = CI 0.9, 2.5), respectively.

Diabetes was independently associated with an increased risk for acute hepatitis B among adults without HBV risk behaviors.

Most manufacturers of blood glucose monitoring equipment do not give advice regarding the use of their meters and strips onboard aircraft, and some airlines have blood glucose testing equipment in the aircraft cabin medical bag. Previous studies using older blood glucose meters (BGMs) have shown conflicting results on the performance of both glucose oxidase (GOX)- and glucose dehydrogenase (GDH)-based meters at high altitude. The aim of our study was to evaluate the performance of four new-generation BGMs at sea level and at a simulated altitude equivalent to that used in the cabin of commercial aircrafts.

Blood glucose measurements obtained by two GDH and two GOX BGMs at sea level and simulated altitude of 8000 feet in a hypobaric chamber were compared with measurements obtained using a YSI 2300 blood glucose analyzer as a reference method. Spiked venous blood samples of three different glucose levels were used. The accuracy of each meter was determined by calculating percentage error of each meter compared with the YSI reference and was also assessed against standard International Organization for Standardization (ISO) criteria. Clinical accuracy was evaluated using the consensus error grid method. The percentage (standard deviation) error for GDH meters at sea level and altitude was 13.36% (8.83%; for meter 1) and 12.97% (8.03%; for meter 2) with p = .784, and for GOX meters was 5.88% (7.35%; for meter 3) and 7.38% (6.20%; for meter 4) with p = .187.

There was variation in the number of time individual meters met the standard ISO criteria ranging from 72–100%. Results from all four meters at both sea level and simulated altitude fell within zones A and B of the consensus error grid, using YSI as the reference.

Overall, at simulated altitude, no differences were observed between the performance of GDH and GOX meters. Overestimation of blood glucose concentration was seen among individual meters evaluated, but none of the results obtained would have resulted in dangerous failure to detect and treat blood glucose errors or in giving treatment that was actually contradictory to that required.

To evaluate the feasibility of an implantable subconjunctival glucose monitoring system (SGMS) for glucose monitoring in humans, we investigated the in vivo performance of the sensor in a clinical trial with five patients.

The new SGMS consists of an implantable ocular mini implant (OMI) and a hand-held fluorescence photometer. The implantable subconjunctival glucose sensor is composed of a fluorescence resonance energy transfer system based on Concanavalin A chemistry, embedded in a nelfilcon polymer hydrogel disk. Blood glucose changes in humans were induced by oral glucose intake and insulin injections.

The in vivo response of the new SGMS was tested in a first human clinical study with five diabetes patients. The OMI was well tolerated in the eyes of the patients. The SGMS exhibited high correlation coefficients (>0.88) with blood glucose changes and a good stability of the sensor response to glucose for the study period of 2 weeks. Lag times were in the range of 5–10 min. A total of 98% of all data pairs was in the clinical acceptable ranges A and B of the consensus error grid.

For the first time, the possibility to measure glucose in vivo in the subconjunctival interstitial fluid for a period of 2 weeks was demonstrated in a human clinical trial.

The accuracy of continuous glucose monitoring (CGM) in non-critically ill hospitalized patients with heart failure or severe hyperglycemia (SH) is unknown.

Hospitalized patients with congestive heart failure (CHF) exacerbation (receiving IV or subcutaneous insulin) or SH requiring insulin infusion were compared to outpatients referred for retrospective CGM.

Forty-three patients with CHF, 15 patients with SH, and 88 outpatients yielded 470, 164, and 2150 meter–sensor pairs, respectively. Admission glucose differed (188 versus 509 mg/dl in CHF and SH, p < .001) but not the first sensor glucose (p = .35). In continuous glucose error grid analysis, 67–78% of pairs during hypoglycemia were in zones A+B (p = .63), compared with 98–100% in euglycemia (p < .001) and 98%, 92%, and 99% (p = .001) during hyperglycemia for the CHF, SH, and outpatient groups, respectively. Mean absolute relative difference (MARD) was lower in the CHF versus the SH group in glucose strata above 100 mg/dl, but there was no difference between the CHF and outpatient groups. Linear regression models showed that CHF versus outpatient, SH versus CHF, and coefficient of variation were significant predictors of higher MARD. Among subjects with CHF, MARD was not associated with brain natriuretic peptide or change in plasma volume, but it was significantly higher in subjects randomized to IV insulin (p = .04).

The results suggest that SH and glycemic variability are more important determinants of CGM accuracy than known CHF status alone in hospitalized patients.

The concept of closed-loop control of glucose, in which continuous glucose sensing is coupled to a fully automated insulin delivery device, without human input, has been an attractive idea for diabetes management. This study presents a new class of hybrid nanogels that can integrate glucose sensing and glucose-responsive insulin release into a single nano-object.

Zinc oxide@poly[N-isopropylacrylamide (NIPAM)-acrylamide (AAm)- 2-aminomethyl-5-fluorophenylboronic acid (FPBA)] hybrid nanogels were synthesized and investigated for size, morphology, volume phase transition, photoluminescence properties, and in vitro insulin release under different glucose concentrations. Glucose sensing was performed both in phosphate-buffered saline (PBS) and in blood samples. The insulin release in PBS of varying glucose levels, as well as a stepwise treatment between two glucose levels (126.0 and 270.0 mg/dl), was performed to test the glucose-responsive insulin release ability of the hybrid nanogels.

Zinc oxide@poly(NIPAM-AAm-FPBA) hybrid nanogels can sensitively and selectively detect glucose in highly reproducible fluorescent signals over the clinically relevant glucose concentration range of 18–540 mg/dl. The glucose-responsive volume phase transition of the nanogels can further regulate the release of the preloaded insulin. The insulin release from the nanogels exhibits the slowest rate (~5% released in 76 h) at a normal glucose level (108.0 mg/dl) but becomes quicker and quicker as the glucose increases to higher and higher levels.

The rationally designed hybrid nanogel can optically signal the glucose level with high sensitivity and selectivity and simultaneously regulate the insulin release rate in response to the glucose reading, which shows a promising concept toward the development of a miniaturized closed-loop glycemic control system.

Safe and effective closed-loop control (artificial pancreas) is the ultimate goal of insulin delivery. In this study, we examined the performance of a closed-loop control algorithm used for the overnight time period to safely achieve a narrow target range of blood glucose (BG) concentrations prior to breakfast. The primary goal was to compare the quality of algorithm control during repeated overnight experiments.

Twenty-three subjects with type 1 diabetes performed 2 overnight experiments on each of three visits at the study site, resulting in 138 overnight experiments. On the first evening, the subject's insulin therapy was applied; on the second, the insulin was delivered by an algorithm based on subcutaneous continuous glucose measurements (including meal control) until midnight. Overnight closed-loop control was applied between midnight and 6 a.m. based on hourly venous BG measurements during the first and second nights.

The number of BG values within the target range (90–150 mg/dl) increased from 52.9% (219 out of 414 measurements) during the first nights to 72.2% (299 out of 414 measurements) during the second nights (p < .001, X ²-test). The occurrence of hypoglycemia interventions was reduced from 14 oral glucose interventions, the latest occurring at 2:36 a.m. during the first nights, to 1 intervention occurring at 1:02 a.m. during the second nights (p < .001, X ²-test).

Overnight controller performance improved when optimized initial control was given; this was suggested by the better metabolic control during the second night. Adequate controller run-in time seems to be important for achieving good overnight control. In addition, the findings demonstrate that hourly BG data are sufficient for the closed-loop control algorithm tested to achieve appropriate glycemic control.

Impaired dexterity has been reported to be prevalent in diabetes patients independent from the existence of diabetic neuropathy. This study was performed to investigate the impact of dexterity impairment on patient preference for two insulin pen injection devices (InnoLet and FlexTouch).

Ninety patients [54 male/36 female; age (mean ± standard deviation), 62 ± 8 years; disease duration, 18 ± 11 years; hemoglobin A1c, 7.2 ± 1.0%] were included in this investigation and were stratified into four different groups based on the results of a dexterity test (Jebsen—Taylor Hand Function Test) and assessment of visual impairment: 15 type 1 (group A) and 30 type 2 (group B) patients with impaired dexterity, 30 type 1/type 2 patients with visual impairment (group C), and 15 type 1/type 2 patients without any impairment (group D). The patients performed a cognitive function test (number connection test), were introduced to the devices in random order, and were asked to perform some mock injections before completing a six-item standardized preference questionnaire.

There was a strong preference for FlexTouch in all groups. All unimpaired patients (100%, group D) preferred FlexTouch, as did the vast majority in all other groups. Only 11% of the patients with impaired cognitive function preferred InnoLet, as did a few patients with more severely impaired dexterity or with visual impairment (group A, 13%; group B, 3%; group C, 14%).

Patient dexterity skills may have an influence on device preference, especially if the impairment is more pronounced.

The clinical significance of blood glucose meter (BGM) error in the presence of increasing carbohydrate errors in diabetes patients who use both the BGM result and the carbohydrate estimation to dose insulin is unknown.

This Monte Carlo simulation modeled diabetes patients who calculate insulin dosages based on BGM results and carbohydrate estimations. It evaluated the likelihood of on-target insulin dosing and clinically significant insulin dose errors based on data from five BGMs with different levels of performance (expressed as bias and imprecision [coefficient of variation (%CV)]) and increasing levels of carbohydrate estimation errors. The study was performed across three separate preprandial glucose (PPG) ranges (90–150, 150–270, and 270–450 mg/dl).

When carbohydrate estimation is accurate (%CV = 0%), the likelihood for on-target insulin doses ranged 50.1–98.5%. The likelihood depended on BGM performance and PPG range. In the presence of carbohydrate estimation errors (%CV = 5–20%), the likelihood of on-target insulin dosages markedly decreased (range, 27.2–80.1%) for all BGMs, the likelihood of insulin underdosing (range, 0–12.8%) and overdosing (range, 0–32.3%) increased, and the influence of BGM error on insulin dosing accuracy was blunted. Even in the presence of carbohydrate error, the BGM with the best performance (bias 1.35% and %CV = 4.84) had the highest probability for on-target insulin dosages.

Both BGM and carbohydrate estimation error contribute to insulin dosing inaccuracies. The BGM with the best performance was associated with the most on-target insulin dosages.

Language barriers are significant hurdles for chronic disease patients in achieving self-management goals of therapy, particularly in settings where practitioners have limited nonprimary language skills, and in-person translators may not always be available. S-MINDS© (Speaking Multilingual Interactive Natural Dialog System), a concept-based speech translation approach developed by Fluential Inc., can be applied to bridge the technologic gaps that limit the complexity and length of utterances that can be recognized and translated by devices and has the potential to broaden access to translation services in the clinical settings.

The prototype translation system was evaluated prospectively for accuracy and patient satisfaction in underserved Spanish-speaking patients with diabetes and limited English proficiency and was compared with other commercial systems for robustness against degradation of translation due to ambient noise and speech patterns.

Accuracy related to translating the English-Spanish-English communication string from practitioner to device to patient to device to practitioner was high (97–100%). Patient satisfaction was high (means of 4.7–4.9 over four domains on a 5-point Likert scale). The device outperformed three other commercial speech translation systems in terms of accuracy during fast speech utterances, under quiet and noisy fluent speech conditions, and when challenged with various speech disfluencies (i.e., fillers, false starts, stutters, repairs, and long pauses).

A concept-based English-Spanish speech translation system has been successfully developed in prototype form that can accept long utterances (up to 20 words) with limited to no degradation in accuracy. The functionality of the system is superior to leading commercial speech translation systems.

Cardiac autonomic neuropathy (CAN) is a serious complication of longstanding diabetes and is associated with an increased morbidity and reduced quality of life in patients with diabetes. The present study evaluated the prevalence of CAN diagnosed by reduced heart rate variability (HRV) using a newly developed device in a large, unselected, hospital-based population of patients with diabetes.

The study examined 323 patients consisting of 206 type 1 diabetes (T1DM) patients and 117 type 2 diabetes (T2DM) patients. The new handheld prototype Vagus™ was used to screen for CAN. Three different standardized cardiac reflex tests were performed to calculate HRV: 30:15 ratio, E:I ratio, and the Valsalva maneuver. An abnormal HRV in one test is indicative of early CAN, and if two or more tests show abnormal HRV, the diagnosis of CAN is established.

In total, 86% of examined patients completed all three tests. Each test was completed by more than 90% of the patients. The prevalence of established CAN was 23%, whereas 33% of the patients had early signs of CAN. The prevalence was higher in T2DM patients (27.8%) than in T1DM patients (20.6 %), p = .02. Patients with CAN were older and had a longer duration of diabetes, higher systolic blood pressure, more nephropathy and retinopathy, and a higher vibration threshold.

Cardiac autonomic neuropathy is frequent in both T2DM and T1DM patients, especially in those with other late diabetes complications. Screening for CAN with the new device is feasible.

In times of short health care budgets, reimbursement for self-monitoring of blood glucose (SMBG) in diabetes patients without insulin treatment is subject to debate. The Structured Testing Program (STeP) trial found a positive correlation of test frequency and improved hemoglobin A1c (HbA1c) levels in poorly controlled type 2 diabetes patients not treated with insulin.

A structured literature search for other clinical studies reporting on SMBG frequency was performed.

There is scarce evidence: Three trials, including STeP, noted a significant and relevant correlation between testing frequency and improved HbA1c levels (FA effect), whereas two studies did not. The comparability between the identified studies is problematic.

Future research should consider correlations between testing frequency and level of glycemic control. More emphasis should be placed on a structured approach to use SMBG and to address adherence to testing and therapy.