New evidence for blood glucose monitoring

20.04.2011 11:25

The 12-month data from the STeP (Structured Testing Protocol) study just presented by Roche Diagnostics show that the application of a new concept for the treatment of diabetes - consisting of structured self-monitoring of blood glucose (SBMG), more visual Preparation of the recorded data, analysis of regularities in blood sugar levels and appropriate adjustment of therapy – can make a significant contribution to reducing HbA1c levels and improving glycemic control. The results of the study were presented as part of the Roche Diabetes Care Symposium “Structured testing and therapeutic support for personalized diabetes management” at the 46th annual meeting of the European Association for the Study of Diabetes (EASD) and at the “Diabetes Media Dialogue” at Hohenkammer Castle .

There is widespread consensus regarding the role of self-monitoring of blood glucose as a core component of the effective treatment of insulin-dependent type 1 or type 2 diabetes. The value and benefit of self-monitoring of blood glucose in insulin-naïve people with type 2 diabetes remains controversial. A few weeks ago, the G-BA decided on a far-reaching exclusion of reimbursement on the recommendation of IQWiG. 

According to Roche, the 6-month interim results and a synopsis were brought to IQWiG's attention in autumn 2009, but were not included in the assessment. No wonder, because for "a sufficient assessment" the IQWiG considers "at least a publication containing all essential details about the design and results (usually in a scientific journal) or a study report" to be necessary, as the deputy director of the institute PD Dr . Stefan Lange announced at the request of “Monitor Healthcare Research”.
And the G-BA only relies on the IQWiG assessment. According to Roche, there was no opportunity for the G-BA to take the new evidence into account in the decision, despite information from the Association of Diagnostic Manufacturers (VDGH) in the comment process and after the study was completed.

The STeP study is, after all, a prospective, two-arm and multicenter RCT study. However, in one control arm a patient group with blood glucose measurement (BZM) was not measured, in the other one without BZM. But that apparently doesn't quite fit into the grid of the studies that were included in the assessment by IQWiG: The five studies evaluated were "null studies": Here the effect of blood sugar testing was compared to no blood sugar testing.

But Roche assumes that BZM per se is useful and wanted to find out which measurement approach was better: the measurement that was previously used in diabetes therapy (at rather undefined times and without instructions as to what conclusions can be drawn from the values) or a fairly new approach in the form of structured blood sugar testing. It is no longer measured every day, but rather in a “structured blood sugar measurement” on three days in a row at specific times.

About the study: The one-year prospective multicenter cluster-randomized clinical STeP study examined the effects of structured blood glucose self-monitoring on glycemic control, diabetes-related psychological distress and clinical depression. The study population included 483 poorly controlled (ITT; HbA1c ≥ 7.5 %) people with type 2 diabetes who were not treated with insulin. The study participants were randomly assigned to either the active control group (AKG) or the study group (STG). Appropriate assessments were made at entry into the study and in months 1, 3, 6, 9 and 12. Patients in the control group (AKG) received usual care (according to US standard guidelines). This was supplemented by quarterly diabetes-specific examinations, the determination of the HbA1c value and the discussion of existing SMBG data. The patients in the study group (STG) received the same care as the AKG patients; in addition, the new SMBG-focused concept for diabetes treatment under investigation was used in these patients. This concept is based on the quarterly structured collection and recording of 7-point blood sugar profiles on three consecutive days. Accu-Chek was used to easily implement the STG protocol^® 360° View Tool used, a form-based, application-friendly analysis system. The STG patients had to adhere to the protocol and discuss the recorded profiles with their doctor or diabetes educator as part of their routine examinations. All STG patients received standard instruction in blood glucose self-monitoring and the analysis of daily blood glucose profiles. The attending physician or diabetes consultant was provided with an algorithm for suggestions for drug treatment tailored to the blood sugar profile. At quarterly visits, all patients completed quality of life questionnaires, focusing on diabetes-related distress (DDS), clinical depression (PHQ-8), and positive well-being (WHO-5).

The result: Intent-to-treat analyzes (ITT) demonstrated significant improvements in HbA1c and DDS, PHQ-8 and WHO-5 scores in both groups. After 12 months, the STG patients showed a significantly greater reduction in HbA1c values compared to the AKG patients (-1.2 % vs. -0.9 %; Δ = -0.3 %, p = 0.04 ). Further analysis of the data from the STG group showed a significant reduction in blood sugar levels in all pre- and postprandial measurements (p < 0.01) as well as a significant reduction in the mean amplitude of glycemic deviations (MAGE, p = 0.005). Quality of life assessment showed significant improvements in DDS, PHQ-8 and WHO-5 scores in both groups at 3, 6, 9 and 12 months (p < 0.001). STG patients who had a DDS score ≥ 3 (significant diabetes-related distress) or a PHQ-8 score ≥ 10 (clinical depression) at entry into the study achieved significantly greater improvements in these scores than the AKG patients (p < 0.04 or p < 0.005).

The results of the study were presented by PD Dr. Bernhard Kulzer (Diabetes Center Bad Mergentheim, FIDAM - Diabetes Research Institute) at the “Diabetes Media Dialogue” in his lecture “The G-BA decision to reimburse urine and blood sugar test strips and its consequences” from page 11 in this document before.

Sources:

Polonsky W, et al. Structured Blood Glucose Monitoring Intervention Leads To Significant Glycaemic Improvement In Poorly Controlled, Non-Insulin Treated Type 2 Diabetes: Results From The STeP Study. Diabetologia. 2010:53 [Suppl 1]; Abstract 1043, p. 417
Fisher L, et al. Structured Blood Glucose Monitoring Reduces Distress And Depression, And Enhances Well-Being in Poorly Controlled, Non-Insulin Treated Type 2 Diabetes: Results From The STeP Study. Diabetologia. 2010:53 [Suppl 1]; Abstract 1049, p. 419