CADTH OPTIMAL THERAPY NEWSLETTER1

Since its adoption into clinical practice in the early 1980s, self-monitoring of blood glucose (SMBG) has emerged as the primary means of supporting blood glucose management outside the clinical setting. Clinical practice guidelines widely advocate its use for all people living with diabetes. But despite SMBG being common practice, there is uncertainty about its benefits — especially in patients with type 2 diabetes not using insulin. How frequently people should test has also been unclear.

In Canada, SMBG is routine among patients with type 2 diabetes not using insulin, with over 50% of the expenditure for blood glucose test strips from these patients.

As healthcare providers, you want what is best for your patients with type 2 diabetes, both clinically and economically. You want to maximize health outcomes and you don’t want your patients or the health care system to pay for interventions that won’t contribute to this goal. So, with all that in mind, you need to know the answers to the following questions:

• Should people with type 2 diabetes not using insulin be testing their blood glucose? What about those with insulin-treated type 2 diabetes?

• If yes, how often should they be testing?

This is important information when considering the best way to support

Everyone With Type 2 Diabetes Should Do It … Shouldn’t They?

good health for your patients living with diabetes and how best to use our finite health care resources.

Your Patients With Type 2 Diabetes Given the increasing prevalence of type 2 diabetes, chances are that a significant portion of your practice consists of patients in this category. They include those managing their diabetes through diet and exercise alone and those taking oral antidiabetes drugs. Should these patients be testing their blood glucose at home?

A systematic review conducted by the Canadian Agency for Drugs and Technologies in Health (CADTH) identified several randomized controlled trials (RCTs) evaluating SMBG in patients with non–insulin-treated type 2 diabetes. Pooling of results from seven RCTs demonstrated that SMBG is associated with a statistically significant, but not clinically relevant, improvement in glycemic control (difference in A1C = – 0.25%, 95% CI – 0.36%, – 0.15%). A similar effect on A1C was observed regardless of whether or not education was provided to help patients interpret and act upon SMBG results. For patients with type 2 diabetes who were not using pharmacotherapy to control their diabetes, improvements in glycemic control were less pronounced and statistically non-significant.

In summary, the clinical review demonstrates that SMBG in patients with type 2 diabetes not treated with insulin does not result in clinically significant improvement of glycemic control.

The cost-effectiveness analysis using

clinical data from the systematic

review found that SMBG, at a frequency

of around nine tests each week in

patients with type 2 diabetes not

treated with insulin, was associated

with an incremental cost of $113,643

per quality-adjusted life-year (QALY)

gained (exceeding widely cited cost-

effectiveness thresholds). The results

did not change substantially when

considering patients with greater

baseline A1C or those treated with oral

antidiabetes drugs alone.

CADTH Optimal Therapy Newsletter

Self-Monitoring of Blood Glucose

The Bottom Line

• For most adults with type 2 diabetes who are taking oral antidiabetes medication:

• Routine SMBG is not required. • Testing may be required in some

situations, but only if it helps to determine a specific course of action by the patient (see list on page 2).

• For most adults with type 2 diabetes who control their diabetes through diet alone:

• Routine SMBG is not required.

CADTH OPTIMAL THERAPY NEWSLETTER2

The Optimal Therapy Newsletter is published by:

Canadian Agency for Drugs and Technologies in Health

The Canadian Agency for Drugs and Technologies in Health (CADTH) is a national body that provides Canada’s federal, provincial and territorial health care decision makers with credible, impartial advice and evidence based information about the effectiveness and efficiency of drugs and other health technologies.

600-865 Carling Avenue Ottawa, ON Canada K1S 5S8 Tel: 613-226-2553Fax: 613-226-5392www.cadth.ca We welcome your feedback.

Please send comments to: compusfeedback@cadth.ca

The information in this document is not a substitute for clinical judgment in the care of a particular patient. CADTH is not liable for any damages arising from the use or misuse of any information contained or implied by the information in this document. The statements, conclusions and views expressed herein do not necessarily represent the view of Health Canada or any Provincial or Territorial Government. Made possible through funding from Health Canada.

Your Patients with Type 2 Diabetes Using InsulinIn patients with insulin-treated

type 2 diabetes, low-quality evidence

suggests that SMBG is associated with

improvements in glycemic control.

However, there was insufficient clinical

evidence to determine the optimal

frequency of testing.

The cost-effectiveness analysis indicates

that testing frequencies beyond 21 strips

per week is unlikely to provide good value

for money; and the lower the number

used per week, the more cost-effective

the practice is likely to be. It is suggested

that SMBG performed more than 14 times

per week on average would have to be

associated with a large benefit in terms of

A1C (i.e. greater than one per cent) for it

to be considered cost-effective.

Consider SMBG (or More Frequent SMBG) in the Following Patient Situations

• Multiple daily insulin injections

• Newly initiated on insulin

• History of, or at increased risk for,

hypoglycemia

• Acute illness

CADTH Optimal Therapy NewsletterSelf-Monitoring of Blood Glucose

Type 1 DiabetesThere is limited evidence but clinical experience and standards of practice suggest that for people with type 1 diabetes SMBG should be individualized to guide adjustments in insulin therapy to achieve optimal blood glucose control.

The Bottom Line

• For most adults with type 2 diabetes who require basal insulin:

• SMBG should be tailored to best guide them in achieving optimal blood glucose control. • This should require no more than 14 tests each week, on average, for most patients.

If recent recommendations on SMBG were adopted in Canada, health outcomes for those living with diabetes would not be compromised, while over $150 million annually could be redirected to other priorities. This is important when considering the best way to support good health for people with diabetes and how best to use our finite health care resources.

• Changes in insulin or other

medication dose/regimen, or

significant changes in routine

• Poorly controlled or unstable

blood glucose levels

• Pregnant or planning to

become pregnant

• Working in an occupation where

hypoglycemia poses safety concerns

There’s More to Self-Management Than Blood Glucose Readings

Self-monitoring of blood glucose is not synonymous with self-management of diabetes. Other important aspects of effective self-management of diabetes by your patients include:• Regular visits with diabetes

health team• Taking all prescribed medications

as directed• Monitoring blood pressure• Eating a healthy, nutritious diet• Exercising regularly• Maintaining a healthy weight• Ensuring good foot care• Effectively managing stress• Talking to their doctors about

A1C results• Managing cholesterol.

Total Spending in Canadian Publicly and Privately Funded Drug Plans on Blood Glucose Test Strips Exceeded

Patients with diabetes who are using insulin

Patients with diabetes who are not using insulin

$144,000,000

$188,000,000

$330 Million* in 2006

If practice changes to reflect the evidence, more than $150 million* would be freed up to be spent elsewhere. Patient health would not be affected negatively.

Disclaimer: This information is not a substitute for professional medical advice or care. CADTH is not liable for any damages resulting from the use or misuse of information contained in or implied by the information in this document.

*This estimate is based on data from eight publicly funded drug plans in Canada (British Columbia, Manitoba, Newfoundland and Labrador, Non-Insured Health Benefits, Nova Scotia, Ontario, Quebec, and Saskatchewan) plus data from 67% of privately funded drug plans that submitted data to Brogan Inc. Some patients in the dataset could not be classified by province or territory; therefore, the estimate is understated.

For project information, visit the CADTH website:www.cadth.ca/smbg

The Canadian Agency for Drugs and Technologies in Health (CADTH) is an independant not-for-profit agency that provides Canada’s federal, provincial, and territorial health care decision makers with credible, impartial advice and evidence-based information about the effectiveness and efficiency of drugs and other health technologies.

WHEN CONSIDERING SELF-MONITORING OF BLOOD GLUCOSEMY PATIENT BOTTOM LINE *

Person with type 1 and type 2 diabetes using basal-bolus insulin regimens

Adult with type 2 diabetes using basal insulin

Adult with type 2 diabetes managed on oral antidiabetes drugs

Adult with type 2 diabetes controlled by diet alone

Self-monitoring of blood glucose should be individualized to guide adjustments in insulin therapy to achieve optimal blood glucose control

Self-monitoring of blood glucose should be individualized, but testing of up to 14 times per week should be sufficient for most patients at most times

Routine self-monitoring of blood glucose is not required. Periodic testing in selected patients (e.g. those with unstable glucose levels, acute illness, pharmacotherapy changes, risk of hypoglycemia with insulin secretagogues like glyburide) should be linked to specific patient actions (e.g., prevention or treatment of hypoglycemia, self-directed dosage adjustment).

Routine self-monitoring of blood glucose is not required.

These recommendations, which include clinical and cost-effectiveness evidence, should be taken into account along with each patient’s unique situation when recommending self-monitoring of blood glucose. The evidence shows that patient health will not be affected in a negative way.

Disclaimer: This information is not a substitute for professional medical advice or care. CADTH is not liable for any damages resulting from the use or misuse of information contained in or implied by the information in this document.

For more project information, visit the CADTH website:www.cadth.ca/smbg

*

Canadian Agency forDrugs and Technologies

in Health

Agence canadienne des médicaments et des technologies de la santé

Children with type 2 diabetesGestational diabetesType 1 or type 2 diabetes during pregnancy Canada’s First Nations populationWorkers where hypoglycemia may pose an occupational risk Patients with a history of hypoglycemia, newly initiated on insulin, experiencing acute illness, undergoing changes in insulin dose/regimen or significant changes in routine, or poorly controlled or unstable blood glucose levels.

Macrovascular and microvascular complicationsPatient quality of life and self-management Death.

Project HighlightsDecember 2009

This brochure provides highlights of the clinical and economic evidence from the work of the Canadian

Agency for Drugs and Technologies in Health (CADTH) on the self-monitoring of blood glucose. It focuses on

the optimal use of test strips that measure blood glucose by those living with diabetes in Canada.

For additional information, please contact the CADTH Liaison Officer for your jurisdiction.

Contact information and detailed reports and tools are available at www.cadth.ca.

The CADTH clinical and economic analyses revealed areas where further research on the value of self-monitoring of blood glucose is required:

For Research Funding Agencies,Researchers, and Others

For Policy-Makers and Managers

The information in these Project Highlights is not a substitute for clinical judgment in the care of a particular patient. CADTH is not liable for any damages arising from the use or misuse of any information contained in or implied by the information in this document.

CADTH is a national body that provides federal, provincial, and territorial health care decision makers with credible, impartial advice and evidence-based information

about the effectiveness and efficiency of drugs and other health technologies

The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any provincial or territorial government.

Made possible through funding from Health Canada. Copyright © 2009 CADTH.

Instead of limiting the results to the effect on A1C levels, researchers evaluating the effectiveness of SMBG are encouraged to report on clinically important outcomes, including:

toFrom Evidence

Improved HealthOutcomes

For patients with type 2 diabetes, not using insulin:

The systematic review of clinical evidence shows a modest improvement in glycemic control that translates into a small reduction in longer-term diabetes complications.

The cost-effectiveness analysis shows that routine use of blood glucose test strips for SMBG by these patients (at least one test strip each day, on average) is associated with a cost of $113,643 per QALY gained, compared to no SMBG.

A reduction in the price of blood glucose test strips would improve the cost-effectiveness of SMBG.

Self-monitoring of blood glucose (SMBG) has unclear benefits in patients with type 2 diabetes who do not use insulin.

Expenditure on blood glucose test strips is significant.

Blood glucose test strips are among the top five classes regarding total expenditure, with costs in some publicly funded provincial drug plans exceeding those for all oral antidiabetes drugs combined.

Over 50% of spending on blood glucose test strips is for patients who are not using insulin.

Decisions regarding the prescribing and reimbursement of blood glucose test strips require consideration of both clinical and cost-effectiveness information.

Total Spending on Blood Glucose Test Strips in Canadian Publicly and Privately Funded Drug Plans Exceeded $330 Million* in 2006Patients with diabetes who are using insulin

Patients with diabetes who are not using insulin

$144,000,000

$188,000,000

*This estimate is based on data from eight publicly funded drug plans in Canada (British Columbia, Manitoba, Newfoundland and Labrador, Non-Insured Health Benefits, Nova Scotia, Ontario, Quebec, and Saskatchewan) plus data from 67% of privately funded drugs plans that submitted data to Brogan Inc. Some patients in the dataset could not be classified by province or territory; therefore, the estimate is understated.

“This represents the first Canadian economic analysis that explores the impact of the price of test strips on cost-effectiveness of SMBG.”

— CADTH SMBG Cost-Effectiveness Report

Results from this research will lead to improved clinical practice and better outcomes for patients with diabetes.

For more information, please visit the CADTH web site:

www.cadth.ca

Self-Monitoring of Blood Glucose ― The Issue:

Self-Monitoring of Blood Glucose — The Conclusions

Blood Glucose Test Strips

SMBG:Self-Monitoring of Blood Glucose.

QALY:Quality-adjusted life-year — a health outcome measure that combines both quantity and quality of life.

Why focus on blood glucose test strips?

Important Terms:

Test strips are used to measure how much glucose there is in the blood of people who have diabetes. Knowing the level of glucose in the blood can help patients monitor how well their management of their diabetes is working. It also guides patients and their health care professionals in making any necessary changes to the patient’s diabetes treatment.

BUT despite self-monitoring of blood glucose (SMBG) being common practice, there is controversy about its benefits for patients with type 2 diabetes not using insulin. How frequently people should test has also been unclear.

AND the cost of test strips to patients and the health care system is significant. When looking at the amount spent on all the different kinds of drugs available, test strips fall into the top five classes in which the Canadian health care system spends the most. In fact, in some provinces, the cost of blood glucose test strips is greater than the cost of all the pills (medications that can be taken by mouth) used to treat diabetes combined.

When decisions about the prescribing, use, and reimbursement of blood glucose test strips are being made, careful consideration of both clinical and cost-effectiveness information is important for answering the following questions:

• Who should be testing their blood glucose? • How often should they be testing?

This is important information when considering the best way to support good health for people living with diabetes and how best to use our finite health care resources.

For Health Care Practitioners? 41For most adults with type 2 diabetes who are using insulin: SMBG should be tailored to best guide them in achieving optimal blood glucose control. This should require no more than 14 tests, on average, each week for most patients.

2“There is routine use of blood glucose test strips among patients with type 2 diabetes who are not using insulin.” — CADTH SMBG Gap Analysis and Key Message Report

For most adults with type 2 diabetes who are taking medication by mouth to control their diabetes: Routine SMBG is not required.

Periodic testing may be required in some situations, but only if it helps to determine a specific course of action by the patient.

There’s More to Self-Management of Diabetes than Blood Glucose Readings

3Over 50% of the expenditure for blood glucose test strips is on patients with type 2 diabetes not using insulin.

For most adults with type 2 diabetes who control their diabetes through diet alone: Routine SMBG is not required.

For people with type 1 or type 2 diabetes using insulin: SMBG should be tailored to best guide them in fine-tuning their insulin therapy to achieve optimal blood glucose control.

If these recommendations became the practice across Canada, health outcomes for those living with diabetes would not be compromised while over $150 million annually could be redirected to other priorities.

Self-monitoring of blood glucose is not synonymous with self-management of diabetes. Other important aspects of effective self-management of diabetes include:

• Visiting your diabetes health team regularly• Taking all prescribed medications as directed• Monitoring blood pressure• Eating a healthy, nutritious diet• Exercising regularly• Maintaining a healthy weight• Ensuring good foot care• Effectively managing stress• Talking to your doctor about A1C results• Managing cholesterol.

Most people with type 2 diabetes do not have to test as often as they do now.