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DIABETIC FOOT ULCER (DFU) MANAGEMENT
POINT-OF-CARE TESTING (POCT)
SELF-MONITORING BLOOD GLUCOSE (SMBG)
About Us…
• Brendalynn Ens, RN, MN, CCN(c)• Background: Cardiovascular & Critical Care Nursing, Flight Nursing with
Saskatchewan Air Ambulance, Administration – CCU, ICU, Respiratory
• Current: Director, Knowledge Mobilization & Liaison Officer Team
(KMLO); CADTH – Saskatchewan
• Jennifer MacPherson, RD, MPH• Background: Clinical, community and public health nutrition, primary care
• Current: Program Officer, KMLO Team (CADTH); Ottawa, ON;
Covering SK Liaison Officer role until June 1st [email protected]
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Diabetic Foot Ulcer (DFU)
Treatment Considerations
What does the evidence say?
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Perspectives on DFU
DFUs affect an estimated 15-25% of people with
diabetes and can lead to serious complications such as
wound infection, osteomyelitis, cellulitis, and amputation.
There are many treatments available for DFUs.
Treatments range widely in their evidence-confirmed
benefits and costs and not all practices that we
commonly see are evidence-based.
2015-2016:
• CADTH reviewed 10 evidence-based guidelines on the
treatment of DFUs, specifically looking at the most
common treatment modalities for particular levels of
Wagner’s Classification of DFU.
• 5 treatments x 10 CPG chart
Source: Canadian Diabetes Association (CDA) 2013 Clinical Practice Guidelines
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Treatment Evidence
Antimicrobial Dressings (including silver)
Mixed evidence on the effectiveness of topical antimicrobials and antimicrobial dressings for treating DFUs.
Mixed evidence on the effectiveness of silver dressings and creams for promoting wound healing and preventing wound infections compared to other treatments.
No evidence-based guidelines for using antimicrobial products on non-infected DFUs.
Compression Therapy Focus on appropriateness for type of pathological condition: Compression therapy (intermittent and compressed air massage) may heal types of DFU
faster than standard care, but patient compliance may be an obstacle to realizing the benefit.
No evidence-based guidelines.
Debridement Depending on clinical appropriateness/type of callus formation, and type of debridement considered (deep vs superficial): Hydrogels and enzyme preparations (clostridial collagenase ointment) appear to be more
effective than standard wound care for DFU treatment (limited evidence). No strong evidence to support the effectiveness of sharp debridement in DFU treatment. Canadian guidelines recommend debridement as part of a broader approach to optimal DFU
treatment.
Negative pressure wound therapy (NPWT)
NPWT appears to work better than other treatments for DFU and it does not seem to increase adverse events.
NPWT seems to be more cost-effective than other treatments for DFU but this may vary by health care setting.
Offloading Devices Non-removable off-loading devices are more effective at healing DFUs than removable off-loading devices.
Cast-walkers may be the most effective removable off-loading device option for DFU treatment.
It is uncertain which devices are most effective for DFU prevention.7
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Shared with Permission:
Saskatchewan Health (2016) Lower Extremity Wound (LEW) Provincial Pathways Committee
Lori Latta, Project Manager [email protected]
Point-of-Care Testing - INR
(POCT)
What does the evidence say?
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POC INR Devices in Canada
CoaguChek XS*
CoaguChek XS Plus*
ProTime*
INRatio*
Cascade
CoaguSense
i-STAT*
Mobius (not yet officially named)
iLine device
•Approximately 350,000 Canadians are taking oral anticoagulation therapy (OAT) –mostly warfarin
•The evolution of point-of-care testing (conducted either by health care professionals or patients) instead of a traditional hospital laboratory setting is in full force!
Options for Implementing POC INR
Patient self-management (PSM)
• Patient self-tests the INR using a POC device, and self-
adjusts the dose of the anticoagulant medication based on
the results using a predetermined algorithm or protocol
Patient self-testing (PST)
• Patient self-tests the INR using a POC device and a
clinician adjusts the dose of anticoagulant medication based
on the results
Clinic-based POC INR testing
• POC testing is performed in a clinical setting such as a
physician’s office or anticoagulation clinic.
Source: Saskatchewan Disease Control lab (SDCL), Ministry of Health, Regina, SK (2015)
Potential Impacts of POC TestingCost Impacts vs. Potential BenefitsBenefits Cost Impacts
Clinical Implementation
turnaround time
decision-making, intervention, risk stratification
perioperative complications
specimen volume needed
Rapid recognition of critical physiologic changes
Improve therapeutic management
in pre-analytical errors (handling, transcription, and
transportation of patient samples)
dependence on prophylactic treatment decisions
risk of infections from blood draws
Variable cost per test for POCT than centralized labs
accuracy may lead to duplicative testing
Charge capture and billing is difficult
Reimbursement may not adequately cover POCT
Resource utilization (potential)
Maintenance
Need to stock test cartridges and related reagents
Periodic quality control and device calibration
Complying with JCAHO and CLIA regulations
Operational Labor and training
Hospital Admissions; ICU and/or hospital stays
efficiency
satisfaction
operating times
need for nurse-intense post-operative care
patient waiting in emergency department
need for outpatient clinic visits
need for follow up physician office visits
safety (needle sticks, handling)
Training for staff
Workload for nurses, unless POCT is assumed by others
Operator proficiency testing
Documentation of quality control and calibrations
IT and connectivity
IT connectivity and integration (lab, billing, EMR…)
Wireless networking for handheld point of care testing
analyzers
CADTH Research: Bottom Line
• POC INR testing with any currently available POC INR
device is an accurate alternative to lab INR testing.
• Mean difference in INR values between POC INR and lab was within
0.5 units the majority of the time – but may increase at high INRs
• Patient self-management (POC INR testing + dose
adjustment) is the most cost-effective option, when feasible.
• Patient self-testing with health care provider dose
adjustment may be an option when lab INR testing is
difficult.
• Clinic-based POC INR testing requires careful consideration
of context and costs.
POC INR Costing Tool ― a tool for decision-makers who are considering the
implementation of POC INR technology. The tool helps estimate the total costs
of patient self-management, patient self-testing, or clinic-based POC INR testing
by allowing users to enter setting-specific information regarding case load,
practice patterns, and costs.
Point-of-Care INR Testing ― a newsletter article summarizing CADTH's work on
POC INR testing for patients taking warfarin or other vitamin K antagonists.
Point-of-Care INR Testing Compared with Lab INR Testing: What Does the
Evidence Say? Tool ― an at-a-glance tool that outlines the different ways POC
INR testing can be used to monitor INR compared with standard laboratory
testing.
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POC INR: More Info
Self-Monitoring of Blood Glucose
(SMBG) for Type II Diabetes
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CADTH Project on Blood Glucose
Monitoring Using Test Strips
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SMBGSelf-monitoring of blood glucose
Systematic Review
Included studies:
RCTs, observational
studies (cohort,
case-control, time
series)
• Patient problem or population:
patients with type 1, type 2, and
gestational diabetes
• Intervention: SMBG
• Comparison: no SMBG & ∆ frequency
of SMBG
• Outcome: effect on A1C,
health-related quality of life, patient
satisfaction, long-term complications,
or mortality
Summary of Meta-Analysis Results: SMBG vs.
no SMBG in adults with T2DM not using insulin
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Clinical Effectiveness — Results and
Interpretation
• SMBG associated with modest improvements in glycemic control among non-insulin T2DM patients.
• Sparse and inconsistent evidence to suggest that SMBG offers benefits in terms of:
health-related quality of life
patient satisfaction
long-term complications or
mortality.
CADTH. Optimal Therapy Report – COMPUS. 2009;3(2).
Cost Effectiveness — Results and
Interpretation
CADTH. Optimal Therapy Report – COMPUS. 2009;3(3).QALY = quality-adjusted life year
• Daily use of SMBG in patients with type 2 diabetes not using insulin is associated with an incremental cost of $113,643 per QALY gained.
Interpretation: does not represent an efficient use of finite health care resources
• Periodic use (one to two test strips per week) may be cost-effective.
• Reducing price of test strips would significantly improve cost-effectiveness.
What does CADTH
recommend?
Adults With Type 2 Diabetes Who Do Not Use
Antidiabetes Drugs
Routine use of blood glucose test strips for
SMBG is not recommended for most adults with type
2 diabetes who do not use diabetes pharmacotherapy.
Adults With Type 2 Diabetes Using Oral
Antidiabetes Drugs
Periodic testing may be beneficial for patients:
• using insulin secretagogues (e.g., sulfonylurea)
• at risk of hypoglycemia
• experiencing acute illness
• undergoing changes in pharmacotherapy or significant changes in routine
• with poorly controlled or unstable glucose levels
• who are pregnant or trying to get pregnant
Routine use of blood glucose test strips for
SMBG is not recommended for most adults with
type 2 diabetes using oral antidiabetes drugs.
Saskatchewan Drug Plan Formulary; Pharmacy Information Bulletin # 595 October 2015.
What Are the Other Opportunities??
• Give patients options to alter how often they self-test—in some cases,
saving time for patients and providers by reducing the frequency
• More focus on other aspects of diabetes self-management:
Blood pressure
Weight management
Healthy diet
Physical activity
Foot care
Dental and eye care
Quitting smoking
Mental health
Questions? Comments?
Jennifer MacPherson
Program Officer, SK Liaison Officer (until June 1st)
Brendalynn Ens, RN, MN, CCN(c)
Director, Knowledge Mobilization & Liaison Officer Program
