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Implementing Standardized Best Practices for Reducing Diabetes Foot Ulcer Risk in a Large Academic Clinic
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Abstracts / Can J Diabetes 37 (2013) S13eS84
extremity amputation and low foot examination rates. In response, the Ottawa Hospital made diabetes foot ulcer prevention a quality improvement priority. Using formal QI methods, foot ulcer risk assessment and stratification, referral processes and self management education were standardized and implemented at 15 weekly diabetes clinics attended by 11 endocrinologists, multiple rotating medical residents and 9 nurses over an 8-month period. The Registered Nurses Association of Ontario and Canadian Diabetes Association practice guidelines informed the process. QI strategies including chart audits, learning sessions, current and future state mapping, and stakeholder surveys, enabled an understanding of practice variations, user needs and concerns and environmental factors impacting care. Evidence-based clinical protocols, documents and resources were developed, tested and adjusted through a series of rapid change cycles. Performance expectations and targets were developed and shared across disciplines. Progress was measured weekly and communicated regularly. Significant improvements were achieved. More than 90% of newly referred patients receive a standardized, 5-item foot exam and risk assessment with over 30% presenting as “higher” risk for ulcers. Patients are informed of their risk factors, education is provided, referrals made for modifiable risk and charts flagged for follow up. Patients and practitioners are highly satisfied with the practice changes. We have demonstrated that even in busy, complex environments, practice can be standardized and change sustained using QI methods.
95 Meta-Analysis of Randomized Controlled Trials of Lixisenatide as Add On to Basal Insulin and/or Oral Antihyperglycemic Agents in Patients with Type 2 Diabetes Mellitus RONALD M. GOLDENBERG*, MANUEL PUIG-DOMINGO, VIVIAN FONSECA, EDWARD C. WANG, JAY LIN, MELANIE J. DAVIES, FRANCISCO JOSÉ TINAHONES, BERNARD CHARBONNEL Thornhill, ON; Barcelona, Spain; New Orleans, LA; Bridgewater, NJ; Flemington, NJ; Leicester, UK; Málaga, Spain; Nantes, France
Figure 1. A1C improvement with 1.8 mg liraglutide is marginally greater at higher baseline BMI. (a) Pooled analysis of the correlation of change in A1C from baseline vs. baseline BMI for liraglutide 1.8 mg: a crude regression line of the analysis is shown in bold (no modeling done), the model-adjusted slope is 0.011% per kg/m2. (b) Forest plots showing the estimated influence of baseline BMI on change in A1C for liraglutide 1.2 mg, 1.8 mg and placebo. Data are modeled estimates with 95% confidence intervals.
A1C reduction of 0.11%. In conclusion, there was no clinically relevant A1C improvement associated with liraglutide with higher baseline BMI (up to 45 kg/m2).
94 Implementing Standardized Best Practices for Reducing Diabetes Foot Ulcer Risk in a Large Academic Clinic JANINE C. MALCOLM*, SHARON M. BREZ, SHERYL M. IZZI, BRIGITTE SKINNER Ottawa, ON Foot ulcers are a common, often preventable complication of diabetes associated with burdens and costs. Recent reports indicate eastern Ontario has a disproportionately high incidence of lower
Aims: To evaluate the safety and efficacy of lixisenatide in combination with basal insulin oral antihyperglycemic agents in patients with type 2 diabetes mellitus (T2DM). Methods: This was a meta-analysis of 1198 patients from 3 phase III, randomized, placebo-controlled trials from the lixisenatide clinical development program (GetGoal-L, GetGoal-Duo-1 and GetGoal-L-Asia). Results: Mean baseline characteristics: age: 57.2 years; diabetes duration: 11.7 years; body mass index: 30.3 kg/m2; mean A1C was 8.2% for lixisenatide vs. 8.1% for placebo. At endpoint, mean A1C was 7.5% vs. 7.9% for lixisenatide and placebo, respectively. A significantly higher proportion of lixisenatide patients achieved A1C <7% vs. placebo (odds ratio [95% CI]: 3.7 [1.6, 8.2], p¼0.0016). Lixisenatide was more than 3 times more likely than placebo to result in A1C <7% and no weight gain (odds ratio [95% CI]: 3.4 [1.7, 6.8], p¼0.0008), more than 2.5 times more likely than placebo to result in A1C <7% and no documented symptomatic hypoglycemia (odds ratio [95% CI]: 2.7 [1.3, 5.4], p¼0.0073) and more than 2.5 times more likely to result in A1C <7% and no weight gain and no documented symptomatic hypoglycemia (odds ratio [95% CI]: 2.6 [1.5, 4.7], p¼0.0009). Conclusions: In patients with T2DM, lixisenatide in combination with basal insulin antihyperglycemic agents is significantly more effective than placebo in achieving A1C <7%, and is more than 2.5 times more likely to result in A1C <7% with no documented hypoglycemia and no weight gain. Lixisenatide is a treatment option as add on to treatment with basal insulin.
Abstracts / Can J Diabetes 37 (2013) S13eS84
extremity amputation and low foot examination rates. In response, the Ottawa Hospital made diabetes foot ulcer prevention a quality improvement priority. Using formal QI methods, foot ulcer risk assessment and stratification, referral processes and self management education were standardized and implemented at 15 weekly diabetes clinics attended by 11 endocrinologists, multiple rotating medical residents and 9 nurses over an 8-month period. The Registered Nurses Association of Ontario and Canadian Diabetes Association practice guidelines informed the process. QI strategies including chart audits, learning sessions, current and future state mapping, and stakeholder surveys, enabled an understanding of practice variations, user needs and concerns and environmental factors impacting care. Evidence-based clinical protocols, documents and resources were developed, tested and adjusted through a series of rapid change cycles. Performance expectations and targets were developed and shared across disciplines. Progress was measured weekly and communicated regularly. Significant improvements were achieved. More than 90% of newly referred patients receive a standardized, 5-item foot exam and risk assessment with over 30% presenting as “higher” risk for ulcers. Patients are informed of their risk factors, education is provided, referrals made for modifiable risk and charts flagged for follow up. Patients and practitioners are highly satisfied with the practice changes. We have demonstrated that even in busy, complex environments, practice can be standardized and change sustained using QI methods.
95 Meta-Analysis of Randomized Controlled Trials of Lixisenatide as Add On to Basal Insulin and/or Oral Antihyperglycemic Agents in Patients with Type 2 Diabetes Mellitus RONALD M. GOLDENBERG*, MANUEL PUIG-DOMINGO, VIVIAN FONSECA, EDWARD C. WANG, JAY LIN, MELANIE J. DAVIES, FRANCISCO JOSÉ TINAHONES, BERNARD CHARBONNEL Thornhill, ON; Barcelona, Spain; New Orleans, LA; Bridgewater, NJ; Flemington, NJ; Leicester, UK; Málaga, Spain; Nantes, France
Figure 1. A1C improvement with 1.8 mg liraglutide is marginally greater at higher baseline BMI. (a) Pooled analysis of the correlation of change in A1C from baseline vs. baseline BMI for liraglutide 1.8 mg: a crude regression line of the analysis is shown in bold (no modeling done), the model-adjusted slope is 0.011% per kg/m2. (b) Forest plots showing the estimated influence of baseline BMI on change in A1C for liraglutide 1.2 mg, 1.8 mg and placebo. Data are modeled estimates with 95% confidence intervals.
A1C reduction of 0.11%. In conclusion, there was no clinically relevant A1C improvement associated with liraglutide with higher baseline BMI (up to 45 kg/m2).
94 Implementing Standardized Best Practices for Reducing Diabetes Foot Ulcer Risk in a Large Academic Clinic JANINE C. MALCOLM*, SHARON M. BREZ, SHERYL M. IZZI, BRIGITTE SKINNER Ottawa, ON Foot ulcers are a common, often preventable complication of diabetes associated with burdens and costs. Recent reports indicate eastern Ontario has a disproportionately high incidence of lower
Aims: To evaluate the safety and efficacy of lixisenatide in combination with basal insulin oral antihyperglycemic agents in patients with type 2 diabetes mellitus (T2DM). Methods: This was a meta-analysis of 1198 patients from 3 phase III, randomized, placebo-controlled trials from the lixisenatide clinical development program (GetGoal-L, GetGoal-Duo-1 and GetGoal-L-Asia). Results: Mean baseline characteristics: age: 57.2 years; diabetes duration: 11.7 years; body mass index: 30.3 kg/m2; mean A1C was 8.2% for lixisenatide vs. 8.1% for placebo. At endpoint, mean A1C was 7.5% vs. 7.9% for lixisenatide and placebo, respectively. A significantly higher proportion of lixisenatide patients achieved A1C <7% vs. placebo (odds ratio [95% CI]: 3.7 [1.6, 8.2], p¼0.0016). Lixisenatide was more than 3 times more likely than placebo to result in A1C <7% and no weight gain (odds ratio [95% CI]: 3.4 [1.7, 6.8], p¼0.0008), more than 2.5 times more likely than placebo to result in A1C <7% and no documented symptomatic hypoglycemia (odds ratio [95% CI]: 2.7 [1.3, 5.4], p¼0.0073) and more than 2.5 times more likely to result in A1C <7% and no weight gain and no documented symptomatic hypoglycemia (odds ratio [95% CI]: 2.6 [1.5, 4.7], p¼0.0009). Conclusions: In patients with T2DM, lixisenatide in combination with basal insulin antihyperglycemic agents is significantly more effective than placebo in achieving A1C <7%, and is more than 2.5 times more likely to result in A1C <7% with no documented hypoglycemia and no weight gain. Lixisenatide is a treatment option as add on to treatment with basal insulin.