Improvement of glycaemia control in subjects with type 2 diabetes by self-monitoring of blood glucose: comparison of two management programs adjusting bedtime insulin dosage

Aim: Self‐monitoring of blood glucose (SMBG) is important for patients treated with insulin to detect asymptomatic hypoglycaemia and to guide patients towards reaching blood glucose goal. This study compared two management programs for adjusting bedtime insulin dose: program 1 (performed by study subjects) vs. program 2 (performed by study subjects and reminded by investigators). Methods: This is a prospective, open‐level, 28‐week randomized trial in poorly controlled type 2 diabetic subjects. One hundred subjects treated with oral antidiabetic drugs plus bedtime insulin with glycated haemoglobin A_1C (A1C) >8.0% were screened and received a structure education package in a 4‐week run‐in period. Seventy‐eight subjects were randomized to two treatment programs (adjust insulin dose by themselves with or without investigators’ reminder) and reviewed by the investigators at a 4‐week interval clinical visit. Results: The mean SMBG decreased significantly in both groups, with a greater decrease observed in program 2 vs. program 1 (from 198.7 ± 43.1 to 122.6 ± 21.9 mg/dl vs. from 194.0 ± 42.7 to 151.6 ± 37.7 mg/dl, p < 0.001). Bedtime insulin dose increased in both groups with a greater increase in program 2 (from 14.4 ± 8.7 to 27.4 ± 12.8 IU vs. from 14.3 ± 8.3 to 18.4 ± 6.2 IU, p < 0.001). There was a significant reduction in A1C from 9.54 ± 1.67% to 7.76 ± 1.27%, with a greater decrease (p < 0.001) in program 2 (2.17%) than in program 1 (1.40%). There were more subjects in the program 2 group achieving the treating targets: mean SMBG ≤120 mg/dl (46.9 vs. 17.9%) and A1C ≤7.0% (54.5 vs. 32.2%). There was no significant difference in the incidence of hypoglycaemia and body weight changes. Conclusions: Systematically titrating bedtime insulin dose added to oral therapy, especially combined with health care reminders, can safely improve glycaemic control in type 2 diabetes with poor glycaemic control. This regimen may facilitate safe and effective insulin therapy in routine medical practice and improve achievement of recommended standards of diabetes care.     

Optical Non-Invasive Glucose Monitoring: Continuous Noninvasive Glucose Monitoring Technology Based on ��Occlusion Spectroscopy��

Background

A truly noninvasive glucose-sensing device could revolutionalize diabetes treatment by leading to improved compliance with recommended glucose levels, thus reducing the long-term complications and cost of diabetes. Herein, we present the technology and evaluate the efficacy of a truly noninvasive device for continuous blood glucose monitoring, the NBM (OrSense Ltd.).

Methods

In vitro analysis was used to validate the technology and algorithms. A clinical study was performed to quantify the in vivo performance of the NBM device. A total of 23 patients with type 1 (n = 12) and type 2 (n = 11) diabetes were enrolled in the clinical study and participated in 111 sessions. Accuracy was assessed by comparing NBM data with paired self-monitoring of blood glucose meter readings.

Results

In vitro experiments showed a strong correlation between calculated and actual glucose concentrations. The clinical trial produced a total of 1690 paired glucose values (NBM vs reference). In the paired data set, the reference glucose range was 40–496 mg/dl. No systematic bias was found at any of the glucose levels examined (70, 100, 150, and 200 mg/dl). The mean relative absolute difference was 17.2%, and a Clarke error grid analysis showed that 95.5% of the measurements fall within the clinically acceptable A&B regions (zone A, 69.7%; and zone B, 25.7%).

Conclusions

This study indicates the potential use of OrSense''s NBM device as a noninvasive sensor for continuous blood glucose evaluation. The device was safe and well tolerated.     

Relaxation treatment of adolescent headache sufferers: results from a school-based replication series

BACKGROUND: In recent reviews of psychological and drug treatment, relaxation training approaches have been found to be efficacious for children and adolescents suffering from recurrent tension-type headache (TTH), while biofeedback procedures provide effective help for migraine headache sufferers, primarily treated in tertiary clinics. OBJECTIVE: In a school-based replication series, the effectiveness and efficiency of relaxation training provided within school settings were examined, in addition to the effects on various headache features and the maintenance of treatment gains at a 6 to 10-month follow-up. METHODS: Over a 20-year period, 288 adolescents aged 10 to 18 years participated in seven randomized, controlled trials conducted within regular school health service settings. Subjects were included if they had suffered from frequent migraine or TTHs, or from both headache types for at least 1 year. Various formats of standardized relaxation training procedures were contrasted to different attention-control (ATCO) approaches or self-monitoring (SM) of headaches in prospective diary recordings. RESULTS: The results showed that a therapist-administered relaxation approach was superior to self-help or school-nurse administered relaxation training approaches, ATCO conditions or SM of headaches. Students with TTHs responded positively to any form of relaxation training, whereas those with frequent migraine responded well only to therapist-administered relaxation. However, school-nurse administered procedures were found to be the most efficient form of relaxation treatment, in particular for adolescents suffering from TTHs. Total headache activity, the number of headache days and peak headache intensity were significantly reduced after relaxation treatment, in addition to medication usage. Treatment gains were well maintained at the 6 to 10-month follow-up. CONCLUSION: Therapist-assisted relaxation training is an effective treatment for adolescents suffering from frequent TTHs or migraine. However, such treatment administered by school-nurses administered within school health care settings is an efficient treatment approach for adolescents suffering from the most common form of primary headache, ie, TTHs.     

Self-monitoring of blood glucose and glycaemic control in type 2 diabetes

OBJECTIVE: Previous studies have shown inconsistent results with regard to whether or not self-monitoring of blood glucose (SMBG) is related to better glycaemic control in type 2 diabetes. The aim of this study was to explore the use of SMBG and its association with glycaemic control in patients with type 2 diabetes in primary care. DESIGN: A cross-sectional observational study was conducted in 2003 at 18 primary health care centres in Sweden, in which all known patients with diabetes were surveyed. The study included 6495 patients with type 2 diabetes. A sample of 896 patients was selected for further exploration of data from medical records. A telephone interview was performed with all patients in this group using SMBG (533 patients). RESULTS: There were no differences in HbA1c levels between users (6.9%) and non-users (6.8%) of SMBG in patients treated with insulin or in patients treated with oral agents (6.3% in both groups). In patients treated with diet only, users of SMBG had higher levels of HbA1c compared with non-users (5.5% vs. 5.4%, p =0.002). Comparing medical records between users and non-users of SMBG showed no differences in diabetes-related complications in any treatment category group. CONCLUSION: The use of SMBG was not associated with improved glycaemic control in any therapy category of patients with type 2 diabetes in primary care. The absence of difference in glycaemic control between users and non-users of SMBG could not be explained by differences in comorbidity between users and non-users of SMBG.     

Are Risk Indices Derived From CGM Interchangeable With SMBG-Based Indices?

Background:

The risk of hypo- and hyperglycemia has been assessed for years by computing the well-known low blood glucose index (LBGI) and high blood glucose index (HBGI) on sparse self-monitoring blood glucose (SMBG) readings. These metrics have been shown to be predictive of future glycemic events and clinically relevant cutoff values to classify the state of a patient have been defined, but their application to continuous glucose monitoring (CGM) profiles has not been validated yet. The aim of this article is to explore the relationship between CGM-based and SMBG-based LBGI/HBGI, and provide a guideline to follow when these indices are computed on CGM time series.

Methods:

Twenty-eight subjects with type 1 diabetes mellitus (T1DM) were monitored in daily-life conditions for up to 4 weeks with both SMBG and CGM systems. Linear and nonlinear models were considered to describe the relationship between risk indices evaluated on SMBG and CGM data.

Results:

LBGI values obtained from CGM did not match closely SMBG-based values, with clear underestimation especially in the low risk range, and a linear transformation performed best to match CGM-based LBGI to SMBG-based LBGI. For HBGI, a linear model with unitary slope and no intercept was reliable, suggesting that no correction is needed to compute this index from CGM time series.

Conclusions:

Alternate versions of LBGI and HBGI adapted to the characteristics of CGM signals have been proposed that enable extending results obtained for SMBG data and using clinically relevant cutoff values previously defined to promptly classify the glycemic condition of a patient.     

Self-Monitoring of Blood Glucose: One STeP Forward?

Introduction

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.

Methods

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

Results

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.

Conclusion

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.     

Interindividual and intraindividual variations in postprandial glycemia peak time complicate precise recommendations for self-monitoring of glucose in persons with type 1 diabetes mellitus

Background

In glycemic control, postprandial glycemia may be important to monitor and optimize as it reveals glycemic control quality, and postprandial hyperglycemia partly predicts late diabetic complications. Self-monitoring of blood glucose (SMBG) may be an appropriate technology to use, but recommendations on measurement time are crucial.

Method

We retrospectively analyzed interindividual and intraindividual variations in postprandial glycemic peak time. Continuous glucose monitoring (CGM) and carbohydrate intake were collected in 22 patients with type 1 diabetes mellitus. Meals were identified from carbohydrate intake data. For each meal, peak time was identified as time from meal to CGM zenith within 40–150 min after meal start. Interindividual (one-way Anova) and intraindividual (intraclass correlation coefficient) variation was calculated.

Results

Nineteen patients were included with sufficient meal data quality. Mean peak time was 87 ± 29 min. Mean peak time differed significantly between patients (p = 0.02). Intraclass correlation coefficient was 0.29.

Conclusions

Significant interindividual and intraindividual variations exist in postprandial glycemia peak time, thus hindering simple and general advice regarding postprandial SMBG for detection of maximum values.