Noninsulin-treated Type Research Articles

Risk of hypoglycaemia among people with type 2 diabetes not treated with insulin: A retrospective analysis of Medicare Advantage beneficiaries.

In 2022, the Centers for Medicare & Medicaid Services released proposed changes to Medicare's continuous glucose monitoring (CGM) coverage policy, making individuals with a history of problematic hypoglycaemia eligible for CGM coverage, irrespective of insulin use. This study estimated the burden of hypoglycaemia in Medicare Advantage beneficiaries with noninsulin-treated type 2 diabetes (T2D). We retrospectively analysed US healthcare claims data using Optum's deidentified Clinformatics® database. Noninsulin-treated beneficiaries were identified in the 16 years from January 2007 to March 2023. Hypoglycaemia-related encounters (HREs) were those accompanied by a hypoglycaemia-specific ICD-9/10 diagnosis code in any position on the claim or the first or second position. HREs following the first claim related to T2D were reported by setting (ambulatory or inpatient/emergency department [ED]). HREs were identified in 689,853 (21.4%) of 3,229,695 noninsulin-treated Medicare Advantage beneficiaries, of whom 82.9% (n = 571,581) had ≥1 HRE in an ambulatory location and 26.8% (n = 184,833) in an ED/inpatient location. Use of sulfonylurea (odds ratio [OR]: 4.33 confidence interval [CI: 4.27-4.38]), evidence of end-stage kidney disease (OR: 2.87 [CI: 2.79-2.94]), hypertension (OR: 3.09 [CI: 3.04-3.15]) and retinopathy (OR: 2.94 [CI: 2.82-3.07]) were the strongest predictors of an HRE (p < 0.001). These findings show that HREs are prevalent in noninsulin-treated diabetes and identify a large number of patients who may benefit from CGM. Because >80% of HREs occur in the ambulatory setting and >70% occur in patients not taking sulfonylureas, primary care providers should be aware of the latest eligibility criteria for Medicare's coverage of CGM and not restrict this technology to their sulfonylurea-treated patients.

Estimating Breakfast Characteristics Using Continuous Glucose Monitoring and Machine Learning in Adults With or at Risk of Type 2 Diabetes

Background: Continuous glucose monitoring (CGM) systems allow detailed assessment of postprandial glucose responses (PPGR), offering new insights into food choices’ impact on dysglycemia. However, current approaches to analyze PPGR using a CGM require manual meal logging, limiting the scalability of CGM-driven applications like personalized nutrition and at-home diabetes risk assessment. Objective: We propose a machine learning (ML) framework to automatically identify and characterize breakfast-related PPGRs from CGM profiles in adults at risk of or living with noninsulin-treated type 2 diabetes (T2D). Methods: Our PPGR estimation framework uses a random forest ML algorithm trained on 15 adults without diabetes who wore a CGM for up to four weeks. The algorithm performance was evaluated on a held-out subset of the participants’ CGM data as well as on an external validation data set of 36 individuals at risk for or with noninsulin-treated T2D. Results: Our algorithm’s estimations of breakfast PPGRs displayed no statistically significant differences to annotated PPGRs, in terms of incremental area under the curve and glucose rise ( P &gt; .05 for both data sets), while a small difference in prebreakfast glucose was found in the nondiabetes data set ( P = .005) but not in the validation T2D data set ( P = .18). Conclusions: We designed an ML framework to automatically estimate the timing of meal events from CGM data in individuals without diabetes and in individuals at risk or with T2D. This could provide a more scalable approach for analyzing postprandial glycemia, increasing the feasibility of CGM-based precision nutrition and diabetes risk assessment applications.

Long-Term Improvements in Glycemic Control with Dexcom CGM Use in Adults with Noninsulin-Treated Type 2 Diabetes.

Aims: The objective of this real-world, observational study was to evaluate change in continuing glucose monitoring (CGM) metrics for 1 year after CGM initiation in adults with noninsulin-treated type 2 diabetes (T2D). Methods: Data were analyzed from Dexcom G6 and G7 users who self-reported: T2D, ≥18 years, gender, no insulin use, and had a baseline percent time in range (TIR) 70-180 mg/dL of ≤70%. Outcomes were change in CGM metrics from baseline to 6 and 12 months overall and for younger (<65 years) and older (≥65 years) cohorts. Additional analyses explored the relationship between use of the high alert feature and change in TIR and time in tight range (TITR) 70-140 mg/dL. Results: CGM users (n = 3,840) were mean (SD) 52.5 (11.2) years, 47.9% female, mean TIR was 41.7% (21.4%), and 12.4% of participants were ≥65 years. Significant improvement in all CGM metrics not meeting target values at baseline was observed at 6 months, with continued improvement at 12 months. Mean baseline TIR increased by 17.3% (32.1%) from 41.7% (21.4%) to 59.0% (28.9%), and mean glucose management indicator decreased by 0.5% (1.2%) from 8.1% (0.9%) to 7.6% (1.1%) (both P < 0.001). Participants who maintained or customized the high alert default setting of 250 mg/dL had a greater increase in TIR and TITR compared with participants who disabled the alert. Days of CGM use over 12 months were high in 84.7% (15.9%). Conclusion: In this large, real-world study of adults with suboptimally controlled T2D not using insulin, Dexcom CGM use was associated with meaningful improvements in glycemic control over 12 months. Use of the high alert system feature was positively associated with glycemic outcomes. High use of CGM over 12 months suggests benefits related to consistent CGM use in this population.

Improved glycemic control after the use of flash glucose monitoring accompanied by improved treatment satisfaction in patients with non-insulin-treated type 2 diabetes: A post-hoc analysis of a randomized controlled trial

AimsIn our previously reported randomized controlled trial in patients with noninsulin-treated type 2 diabetes, the use of flash glucose monitoring (FGM) improved glycated hemoglobin (HbA1c), and the improvement was sustained after the cessation of glucose monitoring. In this post-hoc analysis, we examined data from our trial to identify the factors that influenced FGM efficacy. MethodsWe analyzed data for 48 of 49 participants of the FGM group who completed the trial to clarify the changes in various parameters and factors related to HbA1c improvement with the use of FGM. ResultsAnalyses of the FGM data during the 12-week FGM provision period showed that the weekly mean blood glucose levels considerably decreased as early as at 1 week compared with the baseline values, and this decline continued for 12 weeks. An enhancement in the Diabetes Treatment Satisfaction Questionnaire regarding “willingness to continue the current treatment” score was significantly associated with the improvement in HbA1c at 12 (p = 0.009) and 24 weeks (p = 0.012). ConclusionsGlycemic control was improved soon after FGM initiation, accompanied by improved satisfaction with continuation of the current treatment in patients with noninsulin-treated type 2 diabetes.

Predictors of self-monitoring of blood glucose among noninsulin-treated patients with type 2 diabetes in a primary care setting in Hong Kong: A cross-sectional study.

Objectives:The current study aimed to examine the relationship between patient characteristics (internal psychological, external psychological, internal physical, external physical, and educational) and self-monitoring of blood glucose among noninsulin-treated patients with type 2 diabetes in a local primary care setting.Methods:This was a cross-sectional study, in which data were collected by a structured questionnaire. Correlational and multivariate multiple regression analyses were performed. Three hundred seventy-four noninsulin-treated patients with type 2 diabetes were eligible and completed the questionnaire in August 2019. The response rate was 93.5%. The respondents’ self-reported self-monitoring of blood glucose adherence was the main outcome measure.Results:In predicting self-monitoring of blood glucose adherence, the current regression model accounted for 12.3% of the variance (Adjusted R2 = 0.123, p < 0.05), with internal psychological factors and educational factors being significant. External psychological factors, external physical factors, and internal physical factors were found to be statistically nonsignificant.Conclusion:The findings highlighted the facilitating role of internal psychological factors and educational factors in SMBG adherence in noninsulin-treated type 2 diabetic patients. Among these factors, the education aspect was relatively strongly associated with increased SMBG adherence. With adequate patient education on diabetes and SMBG, the increased literacy would possibly strengthen patients’ internal psychological factors and motivate them to uptake SMBG practice. Implications from the current findings suggested that further research on different SMBG parameters is warranted to fill the knowledge gap in structuring an individualized and targeted SMBG protocol for better diabetic care.

Coronary artery bypass grafting versus percutaneous coronary intervention in patients with noninsulin treated type 2 diabetes mellitus: A meta-analysis of randomized controlled trials.

The outcomes and prognosis of revascularization by either coronary artery bypass grafting (CABG) surgery or percutaneous coronary intervention (PCI) in patients with noninsulin-treated type 2 diabetes mellitus (NITDM) have not yet been well established. Randomized controlled trials (RCTs) were identified by searching Pubmed, EMBASE, and Cochrane library from inception until May 2016. Heterogeneity was evaluated, and the pooled hazard ratio (HR) was calculated by using a fixed-effect model. A random-effect model was used when statistically significant heterogeneity was observed (I2 ≥50%). All data analyses were carried out by using RevMan 5.3 and STATA software 12.0. A total of 4 RCTs involving 5 studies, consisting of 2270 patients with noninsulin-treated type 2 diabetes mellitus, were identified. Compared with CABG-treated patients, PCI-treated patients had significantly higher all-cause mortality (HR 1.39; 95% CI 1.01 to 1.91; P=.04), myocardial infarction (HR 2.14; 95% CI 1.40 to 3.27; P=.0004), repeated revascularization (HR 2.52; 95% CI 1.77 to 3.57; P<.00001), and major adverse cardiovascular and cerebrovascular events (HR 1.50; 95% CI 1.20-1.87; P=.0004). However, PCI was associated with lower incidence of stoke (HR 0.47; 95% CI 0.24 to 0.90; P=.02). In NITDM patients, our study suggests that CABG surgery is associated with reduced risk of mortality and morbidity, although with increased incidence of stroke compared with percutaneous coronary intervention. The decision if to have percutaneous coronary intervention or CABG surgery should factor the risk for stroke of the patients when considering CABG over percutaneous coronary intervention. Adequately powered RCTs are needed to confirm the results of this meta-analysis.

Efficacy and Safety of Cannabidiol and Tetrahydrocannabivarin on Glycemic and Lipid Parameters in Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Pilot Study

Cannabidiol (CBD) and Δ(9)-tetrahydrocannabivarin (THCV) are nonpsychoactive phytocannabinoids affecting lipid and glucose metabolism in animal models. This study set out to examine the effects of these compounds in patients with type 2 diabetes. In this randomized, double-blind, placebo-controlled study, 62 subjects with noninsulin-treated type 2 diabetes were randomized to five treatment arms: CBD (100 mg twice daily), THCV (5 mg twice daily), 1:1 ratio of CBD and THCV (5 mg/5 mg, twice daily), 20:1 ratio of CBD and THCV (100 mg/5 mg, twice daily), or matched placebo for 13 weeks. The primary end point was a change in HDL-cholesterol concentrations from baseline. Secondary/tertiary end points included changes in glycemic control, lipid profile, insulin sensitivity, body weight, liver triglyceride content, adipose tissue distribution, appetite, markers of inflammation, markers of vascular function, gut hormones, circulating endocannabinoids, and adipokine concentrations. Safety and tolerability end points were also evaluated. Compared with placebo, THCV significantly decreased fasting plasma glucose (estimated treatment difference [ETD] = -1.2 mmol/L; P < 0.05) and improved pancreatic β-cell function (HOMA2 β-cell function [ETD = -44.51 points; P < 0.01]), adiponectin (ETD = -5.9 × 10(6) pg/mL; P < 0.01), and apolipoprotein A (ETD = -6.02 μmol/L; P < 0.05), although plasma HDL was unaffected. Compared with baseline (but not placebo), CBD decreased resistin (-898 pg/ml; P < 0.05) and increased glucose-dependent insulinotropic peptide (21.9 pg/ml; P < 0.05). None of the combination treatments had a significant impact on end points. CBD and THCV were well tolerated. THCV could represent a new therapeutic agent in glycemic control in subjects with type 2 diabetes.

The Burden of Structured Self-Monitoring of Blood Glucose on Diabetes-Specific Quality of Life and Locus of Control in Patients with Noninsulin-Treated Type 2 Diabetes: The PRISMA Study.

Background: To evaluate whether structured self-monitoring of blood glucose (SMBG) is associated with changes in diabetes-specific quality of life (DSQoL) and locus of control (LOC) in patients with noninsulin-treated type 2 diabetes (T2DM).Study Design and Methods: In this analysis of the PRISMA (Prospective Randomized Trial on Intensive SMBG Management Added Value in Noninsulin-Treated T2DM Patients) Study psychosocial data, we evaluated the impact of 12 months of structured SMBG on the individual domains of DSQoL and LOC questionnaires, including the role of selected confounders.Results: The score for Satisfaction, Impact, and Worry domains (DSQoL) improved when compared with baseline, without significant differences between structured SMBG regimen (intervention group, n = 501) and active control group (n = 523). Scores for Internal, Chance, and Powerful Others domains (LOC) improved compared with baseline, with a significant between-group change in Chance (P = 0.0309). For DSQoL domain score, improvements were associated with higher number of SMBG measurements (P = 0.007), older age (P = 0.013), and male sex (P = 0.0133) for Satisfaction and with male sex (P < 0.0001) for Worry. Concerning LOC domain score, improvements were associated with longer diabetes duration (P = 0.0084) and younger age (P < 0.0001) for Chance and total number of SMBG measurements (P = 0.0036) for Internal, with the intervention group close to being significant (P = 0.06).Conclusions: Our analysis demonstrates that in patients with noninsulin-treated T2DM, structured SMBG is not associated with a deterioration of quality of life and LOC, which is strongly predicted by demographics and diabetes-related variables. These findings should be considered when tailoring educational support to SMBG for these patients.

Abstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy-February 3-6, 2016.

Abstracts from ATTD 2016 9th International Conference on Advanced Technologies & Treatments for Diabetes Milan, Italy-February 3-6, 2016.

Feasibility of Closed-Loop Insulin Delivery in Type 2 Diabetes: A Randomized Controlled Study

Closed-loop insulin delivery offers a promising treatment option, but to date, it has only been evaluated in type 1 diabetes. Our aim was to evaluate the feasibility of fully closed-loop subcutaneous insulin delivery in insulin-naïve patients with type 2 diabetes. Twelve subjects (seven males, age 57.2 years, BMI 30.5 kg/m2) with noninsulin-treated type 2 diabetes (HbA1c 8.4% [68 mmol/mol], diabetes duration 7.6 years) underwent two 24-h visits (closed-loop and control) in a randomized crossover design. During closed-loop visits, the subjects' routine diabetes therapy was replaced with model predictive control algorithm-driven subcutaneous insulin pump delivery based on real-time continuous glucose monitoring. Meals were unannounced, and no additional insulin was administered for carbohydrates consumed. During control visits, the usual diabetes regimen was continued (metformin 92%, sulfonylureas 58%, dipeptidyl peptidase-4 inhibitors 33%). On both visits, subjects consumed matched 50- to 80-g carbohydrate meals and optional 15-g carbohydrate snacks and remained largely sedentary. Plasma glucose measurements evaluated closed-loop performance. Compared with conventional therapy, 24 h of closed-loop insulin delivery increased overall the median time in target plasma glucose (3.9-8.0 mmol/L) from 24 to 40% (P = 0.016), despite sensor under-reading by a median of 1.2 mmol/L. The benefit of the closed-loop system was more prominent overnight, with greater time in target glucose (median 78 vs. 35%; P = 0.041) and less time in hyperglycemia (22 vs. 65%; P = 0.041). There was no hypoglycemia during either intervention. A closed-loop system without meal announcement and using subcutaneous insulin delivery in insulin-naïve patients with type 2 diabetes appears feasible and safe. Improvement in postprandial glucose control may require further optimization of system performance.

What did inspire me to write the abstract for the EPMA Congress?

Case Report Type 1 Diabetes Mellitus (DM) Male 22 years of age (Figure 1) Insulin dependent since 2003 Visual acuity: OD: 0,10 OS: Light Perception Preparing for surgical treatment Operation rejected because of: Blood hypertension (230/110 mmHg) HBA1C: 10.7 % Anemia Renal Insufficiency (not diagnosed) Hart ischemic changes, left ventricular hypertrophy (not diagnosed) DM is a major cause of avoidable blindness all over the world. Patients with diabetic retinopathy (DR) are 25 times more likely to become blind than non-diabetics. Prevalence of type 1 diabetes is 10-15% of the diabetic population. Prevalence of DR in Wisconsin Epidemiological Study of Diabetic Retinopathy was 50.1 and 54.2% in the diabetes control and complications trial in type 1 diabetes [1] and 35-39% in United Kingdom Prospective Diabetes Study in type 2 diabetes [2]. In two studies from India, the prevalence of DR in type 2 diabetes patients were 34.1% and 37% [3].WHO estimates India has 31.7 million diabetic subjects at present. In USA, DR is the leading cause of new blindness in people 25-74 years of age. Approximately 700,000 persons have proliferative DR (PDR). Each year another 65,000 are diagnosed with the condition. A recent study has estimated that among people with diabetes aged 40 or older, 28.5% will develop DR. Worldwide 20 million people have PDR (very severe eye complication), with this number projected to increase to over 30 million by 2030. After 10 years of onset of DM, blindness was 1.8, 4.0 and 4.8% in type 1, insulin-treated type 2 and noninsulin-treated type 2 patients, respectively. In these three groups of patients, the 10-year incidence visual impairment (loss of 15 letters on a scale of 0-70 letters) was 9.4, 37.2 and 23.9%, respectively [4]. Good glycemic control arrests the development and progression of DR, but still there are a lot of factors that can influence the DR visual loss. Technological advances have improved the diagnostic accuracy of screening methods and given an access to the diabetic patients to the specialist care. In the last decades, the treatment strategies have been revised and besides laser photocoagulation, include surgical interventions and pharmacotherapies. DR will often go unnoticed when the condition is in its early stages but advanced symptoms can include blurred or sudden vision loss. Diabetics are advised to take advantage of the eye screenings which are offered free of charge in the UK, to detect any signs of the disease.

Response to Comment on: Bosi et al. Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes: The PRISMA Randomized Trial. Diabetes Care 2013;36:2887–2894

We thank Kleefstra et al. (1) for their interest in our study (2). However, we disagree with the assertions regarding the clinical relevance of our findings on the use of self-monitoring of blood glucose (SMBG) in noninsulin-treated type 2 diabetes. Although the traditional approach to evaluating the efficacy of pharmacological interventions in type 2 diabetes studies is to report between-group differences in HbA1c reductions, this approach may not be appropriate for assessing the impact of “behavior-based” interventions such as structured SMBG. In pharmacological studies, a medication is administered and investigators measure its efficacy in lowering glucose by comparing the reduction in HbA1c values over time in all patients in the intervention and control group (intent-to-treat [ITT] population). Several researchers, erroneously in our opinion, apply this approach …

Intensive Structured Self-Monitoring of Blood Glucose and Glycemic Control in Noninsulin-Treated Type 2 Diabetes

OBJECTIVEWe aimed to evaluate the added value of intensive self-monitoring of blood glucose (SMBG), structured in timing and frequency, in noninsulin-treated patients with type 2 diabetes.RESEARCH DESIGN AND METHODSThe 12-month, randomized, clinical trial enrolled 1,024 patients with noninsulin-treated type 2 diabetes (median baseline HbA1c, 7.3% [IQR, 6.9–7.8%]) at 39 diabetes clinics in Italy. After standardized education, 501 patients were randomized to intensive structured monitoring (ISM) with 4-point glycemic profiles (fasting, preprandial, 2-h postprandial, and postabsorptive measurements) performed 3 days/week; 523 patients were randomized to active control (AC) with 4-point glycemic profiles performed at baseline and at 6 and 12 months. Two primary end points were tested in hierarchical order: HbA1c change at 12 months and percentage of patients at risk target for low and high blood glucose index.RESULTSIntent-to-treat analysis showed greater HbA1c reductions over 12 months in ISM (−0.39%) than in AC patients (−0.27%), with a between-group difference of −0.12% (95% CI, −0.210 to −0.024; P = 0.013). In the per-protocol analysis, the between-group difference was −0.21% (−0.331 to −0.089; P = 0.0007). More ISM than AC patients achieved clinically meaningful reductions in HbA1c (>0.3, >0.4, or >0.5%) at study end (P < 0.025). The proportion of patients reaching/maintaining the risk target at month 12 was similar in ISM (74.6%) and AC (70.1%) patients (P = 0.131). At visits 2, 3, and 4, diabetes medications were changed more often in ISM than in AC patients (P < 0.001).CONCLUSIONSUse of structured SMBG improves glycemic control and provides guidance in prescribing diabetes medications in patients with relatively well-controlled noninsulin-treated type 2 diabetes.

Using Self-Monitoring of Blood Glucose in Noninsulin-Treated Type 2 Diabetes

In Brief Self-monitoring of blood glucose (SMBG) is considered an essential component of diabetes self-management. However, research has yielded mixed results regarding the value of SMBG for people with type 2 diabetes who are not treated with insulin. Some studies have shown no benefit, whereas others have demonstrated improved A1C and behavior change linked to SMBG in a diabetes self-management education program that teaches how to use SMBG data. When used appropriately in these patients, SMBG can help to identify factors associated with hyper- and hypoglycemia, facilitate learning, and empower patients to make changes to improve their glycemic control. SMBG can also be useful to health care providers, who can teach patients to monitor glucose at specific times to assess the effectiveness of medications and guide medication management. All people with type 2 diabetes should be given the opportunity to learn about the value of and skills required to monitor blood glucose as appropriate to their specific needs.

Prevalencia y factores asociados de la automonitorización glucémica en pacientes diabéticos tipo 2 no tratados con insulina en la Comunidad Valenciana

Self-monitoring of blood glucose (SMBG) in noninsulin-treated type 2 diabetes patients (T2DM) is a controversial topic. We aimed to describe the SMBG prevalence in noninsulin-treated (NIT) T2DM patients in the Valencia Community (VC) and to analyze factors associated with their use. Cross-sectional study with 573 NIT-T2DM patients from 83 primary care surgeries. Electronic medical records and patient interview were used. We examine associations among patient, doctors and organizational characteristics, and the SMBG indication. 289 (50.4%) of the 573 NIT-T2DM patients used SMBG. In the multivariable analysis SMBG use was associated with age (OR:2.3 for 65-84 and 6.0 for <65 years vs 85+ years old)) the length from diagnosis (OR:2.2 for 10-15 years vs 0-5 years), the number of OAAs prescribed (OR:2.5, 4.1 and 5.7 for 1, 2 or 3+ OAAs vs no treatment with OAAs) and type (with more SMBG prescribed in patients with sulfonylureas and glitazones), glycated haemoglobin figures (OR: 1.9 y 1.6 for 7-8 and >8, vs <7), sedentary behaviour (OR:1.6), obesity (OR:1.5), and housewife status, and chronic respiratory disease antecedents (OR:0.5). After controlling these factors, SMBG use was also associated with the length of doctor's professional practice and some healthcare departments. In the Valencia Community the SMBG use in noninsulin-treated T2DM patients is strongly associated with clinic patient' characteristics, but some non-clinical factors explain part of the variance in their utilization.

Meta-analysis: Self-monitoring in non–insulin-treated type 2 diabetes improved HbA1cby 0.25%

Source Citation Farmer AJ, Perera R, Ward A, et al. Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabe...

Comment on: Polonsky et al. Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes: Results From the Structured Testing Program Study. Diabetes Care 2011;34:262–267

We read with interest the article by Polonsky et al. (1) reporting that self-monitoring of blood glucose (SMBG) improves glycemic control in noninsulin-treated type 2 diabetes. In the U.K., SMBG is recommended for insulin-treated diabetes (2), and controversy exists in relation to treatment with lifestyle advice or oral hypoglycemic agents (OHAs). A Cochrane review concluded that there is insufficient evidence to support the use of SMBG in noninsulin-treated type 2 diabetes (3). Furthermore, a health technology assessment review suggests that SMBG has limited clinical effectiveness in improving glycemic control in noninsulin-treated type 2 diabetes (4). In view of the widespread use of SMBG, cost implications, and the fact that U.K. management algorithms are based on HbA …

Response to Comment on: Polonsky et al. Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes: Results From the Structured Testing Program Study. Diabetes Care 2011;34:262–267

We thank Stephens et al. (1) for their comments in response to the Structured Testing Program (STeP) study. It is evident that we share an interest in ensuring that health care resources are used effectively, and we therefore welcome the opportunity to address the issues you have raised. As noted in the letter, a number of studies in noninsulin-treated diabetes have shown data similar to those of Stephens et al.—suggesting that self-monitoring of blood glucose (SMBG), as it is typically done, offers little or no glycemic benefit (2,3). We do …

Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study.

OBJECTIVETo assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes.RESEARCH DESIGN AND METHODSThis 12-month, prospective, cluster-randomized, multicenter study recruited 483 poorly controlled (A1C ≥7.5%), insulin-naïve type 2 diabetic subjects from 34 primary care practices in the U.S. Practices were randomized to an active control group (ACG) with enhanced usual care or a structured testing group (STG) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose (SMBG). STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days. The primary end point was A1C level measured at 12 months.RESULTSThe 12-month intent-to-treat analysis (ACG, n = 227; STG, n = 256) showed significantly greater reductions in mean (SE) A1C in the STG compared with the ACG: −1.2% (0.09) vs. −0.9% (0.10); Δ = −0.3%; P = 0.04. Per protocol analysis (ACG, n = 161; STG, n = 130) showed even greater mean (SE) A1C reductions in the STG compared with the ACG: −1.3% (0.11) vs. −0.8% (0.11); Δ = −0.5%; P < 0.003. Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients, regardless of the patient’s initial baseline A1C level: 179 (75.5%) vs. 61 (28.0%); <0.0001. Both STG and ACG patients displayed significant (P < 0.0001) improvements in general well-being (GWB).CONCLUSIONSAppropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB.

A Single-Center, Open, Comparative Study of the Effect of Using Self-Monitoring of Blood Glucose to Guide Therapy on Preclinical Atherosclerotic Markers in Type 2 Diabetic Subjects

The aim of our study was to determine the effect of treatment based on preprandial and postprandial self-monitoring of blood glucose (SMBG) on the progression of carotid intima-medial thickness (CIMT) in noninsulin-treated type 2 diabetes mellitus (T2DM) subjects. In this 18-month prospective trial, we recruited subjects 18-70 years of age, treated with metformin and sulfonylurea, with a standardized hemoglobin A1c (HbA1c) level < or =9.0%. Subjects were randomized to use of fasting/preprandial (FP) SMBG results to adjust evening medication or use of postprandial (PP) SMBG results to adjust morning medication. The primary end point was change in CIMT; change in HbA1c was a secondary end point. Of the 300 subjects randomized, 280 (140 in each group) completed all biochemical tests and CIMT analysis. Carotid intima-medial thickness was reduced significantly in PP subjects from 0.78 (+/-0.15) mm to 0.73 (+/-0.14) mm (p < 0.005), but no significant CIMT reduction was seen in FP subjects. A significant reduction in HbA1c was also seen in the PP group (p < 0.005) but not in the FP group 1 (p = 0.165). Significant improvements in body mass index (p = 0.038), waist circumference (p < 0.001), systolic blood pressure (p = 0.008), and serum cholesterol (p = 0.02) were also seen in PP subjects but not in FP subjects. Use of postprandial SMBG data to adjust therapy was associated with a significant regression of carotid intima-medial thickening and a reduction in HbA1c in T2DM, whereas no significant improvement in these parameters was seen in subjects who used fasting/preprandial SMBG data for therapy adjustment.