Real-world studies have become increasingly important in providing evidence of treatment effectiveness in clinical practice. While randomized clinical trials (RCTs) are the “gold standard” for ...evaluating the safety and efficacy of new therapeutic agents, necessarily strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered in clinical practice. Real-world studies may use information from electronic health and claims databases, which provide large datasets from diverse patient populations, and/or may be observational, collecting prospective or retrospective data over a long period of time. They can therefore provide information on the long-term safety, particularly pertaining to rare events, and effectiveness of drugs in large heterogeneous populations, as well as information on utilization patterns and health and economic outcomes. This review focuses on how evidence from real-world studies can be utilized to complement data from RCTs to gain a more complete picture of the advantages and disadvantages of medications as they are used in practice.
Funding
: Sanofi US, Inc.
Surveillance du glucose en continu Harris, Stewart B; Bari, Basel; Gilbert, Jeremy
Canadian Medical Association journal (CMAJ),
03/2024, Volume:
196, Issue:
9
Journal Article
Surveillance du glucose en continu Harris, Stewart B.; Bari, Basel; Gilbert, Jeremy
Canadian Medical Association journal (CMAJ),
03/2024, Volume:
196, Issue:
9
Journal Article
Continuous glucose monitoring Harris, Stewart B; Bari, Basel; Gilbert, Jeremy
Canadian Medical Association journal (CMAJ),
11/2023, Volume:
195, Issue:
44
Journal Article
Peer reviewed
Open access
Continuous glucose monitoring (CGM) in diabetes improves outcomes and enhances patient self management. Compared with traditional fingerstick testing, CGM improves glycemic control and quality of ...life, and is now recommended for people with type 1 and type 2 diabetes using basal--bolus insulin. Use of CGM improves glycemic outcomes among people with type 2 diabetes treated with basal insulin alone in the primary care setting. It alerts users to hypo- or hyperglycemia, and promotes healthy behaviors by providing immediate data on lifestyle choices like diet and exercise. Real-time CGM automatically collects and displays glucose data, while intermittently scanned CGM requires manual scanning at least every 8 hours. Real-time CGM has a predictive alert that warns of impending hypoglycemia, an important feature for patients with frequent hypoglycemia or hypoglycemia unawareness. Choosing between systems should be based on patient needs and preferences. Reports can be easily accessed by smartphone, receiver or CGM specific software. These provide easy-to-read glycemic data to identify patterns that can enable effective therapeutic adjustments and reduce clinical inertia. Continuous glucose monitoring can be successfully implemented in primary care, and numerous resources are available to support this.
Considering the development and ongoing influence of Black
thought From 1900 to the present, people of African
descent living in the United States have drawn on homegrown and
diasporic minds to ...create a Black intellectual tradition engaged
with ideas on race, racial oppression, and the world. This volume
presents essays on the diverse thought behind the fight for racial
justice as developed by African American artists and intellectuals;
performers and protest activists; institutions and organizations;
and educators and religious leaders. By including both women's and
men's perspectives from the U.S. and the Diaspora, the essays
explore the full landscape of the Black intellectual tradition.
Throughout, contributors engage with important ideas ranging from
the consideration of gender within the tradition, to intellectual
products generated outside the intelligentsia, to the ongoing
relationship between thought and concrete effort in the quest for
liberation.
Expansive in scope and interdisciplinary in practice, The
Black Intellectual Tradition delves into the ideas that
animated a people's striving for full participation in American
life.
Contributors: Derrick P. Alridge, Keisha N. Blain, Cornelius L.
Bynum, Jeffrey Lamar Coleman, Pero Gaglo Dagbovie, Stephanie Y.
Evans, Aaron David Gresson III, Claudrena N. Harold, Leonard
Harris, Maurice J. Hobson, La TaSha B. Levy, Layli Maparyan,
Zebulon V. Miletsky, R. Baxter Miller, Edward Onaci, Venetria K.
Patton, James B. Stewart, and Nikki M. Taylor
Introduction: Therapeutic inertia is a major contributor to people with diabetes not achieving glycemic goals. We assessed for patients with T2D the impact of using the FreeStyle Libre system (FSL) ...vs. blood glucose monitoring (BGM) on treatment intensification.
Method: We carried out a matched retrospective cohort study using secondary private payer claims data including >30 million diabetes drug and device claims filled by over 850,000 patients with T2D >18 in Canada over 24 months. Each month, patients were classified by level of therapy progression: 1. No diabetes drug therapy; 2. Mono Oral Antihyperglycemic Agents (OHAs) ; 3. Dual OHAs; 4. Triple OHAs; 5. Quad or more OHAs; 6. Injectable GLP1-RA (±concomitant OHAs) ; 7. Basal insulin (±concomitant OHAs) ; 8. MDI insulin (±concomitant OHAs) .
Results: A total of 373,871 patients met the inclusion criteria. Across all treatment cohorts, the FSL treatment groups were found to have a statistically higher probability of treatment intensification relative to BGM:
Conclusion: Reimbursement of FSL for patients with T2D in Canada is associated with decreased time lag for glucose lowering therapy compared to those using BGM alone. These findings suggest that FSL data impact clinicians to facilitate earlier and more intensive therapy modifications and thus reduce treatment inertia.
Disclosure
S.B.Harris: Consultant; Abbott, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Sanofi, Other Relationship; Abbott, AstraZeneca, Bayer Inc., Dexcom, Eli Lilly and Company, HLS Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk, Sanofi, Research Support; Applied Therapeutics Inc., AstraZeneca, Canadian Institutes of Health Research, Juvenile Diabetes Research Foundation (JDRF) , Novo Nordisk, Sanofi, The Lawson Foundation. F.Levrat-guillen: Employee; Abbott.
Funding
Funded by Abbott Diabetes Care
Indigenous peoples in Canada experience higher rates of diabetes and worse outcomes than non-Indigenous populations in Canada. Strategies are needed to address underlying health inequities and ...improve access to quality diabetes care. As part of the national FORGE AHEAD Research Program, this study explores two primary healthcare teams' quality improvement (QI) process of developing and implementing strategies to improve the quality of diabetes care in First Nations communities in Canada.
This study utilized a community-based participatory and qualitative case study methodology. Multiple qualitative data sources were analyzed to understand: (1) how knowledge and information was used to inform the teams' QI process; (2) how the process was influenced by the context of primary care services within communities; and (3) the factors that supported or hindered their QI process.
The findings of this study demonstrate how teams drew upon multiple sources of knowledge and information to inform their QI work, the importance of strengthening relationships and building relationships with the community, the influence of organizational support and capacity, and the key factors that facilitated QI efforts.
This study contributes to the ongoing calls for research in understanding the process and factors affecting the implementation of QI strategies, particularly within Indigenous communities. The knowledge generated may help inform community action and the future development, implementation and scale-up of QI programs in Indigenous communities in Canada and globally.
Emerging evidence suggests that peripheral neuropathy begins in the early stages of diabetes pathogenesis. Our objective was to describe the prevalence of peripheral neuropathy and nerve dysfunction ...according to glucose tolerance and metabolic syndrome status and examine how these conditions are associated with neurological changes in individuals at risk for type 2 diabetes.
We studied 467 individuals in the longitudinal PROMISE (Prospective Metabolism and Islet Cell Evaluation) cohort. Peripheral neuropathy was defined by Michigan Neuropathy Screening Instrument (MNSI) scores (>2), and the severity of nerve dysfunction was measured objectively by vibration perception thresholds (VPTs) using a neurothesiometer. Metabolic syndrome was defined using the International Diabetes Federation/American Heart Association harmonized criteria.
The prevalence of peripheral neuropathy was 29%, 49%, and 50% for normal glycemia, prediabetes, and new-onset diabetes, respectively (P < 0.001 for trend). The mean VPT was 6.5 V for normal glycemia, 7.9 V for prediabetes, and 7.6 V for new-onset diabetes (P = 0.024 for trend). Prediabetes was associated with higher MNSI scores (P = 0.01) and VPTs (P = 0.004) versus normal glycemia, independent of known risk factors. Additionally, progression of glucose intolerance over 3 years predicted a higher risk of peripheral neuropathy (P = 0.007) and nerve dysfunction (P = 0.002). Metabolic syndrome was not independently associated with MNSI scores or VPTs.
In individuals with multiple risk factors for diabetes, prediabetes was associated with similar risks of peripheral neuropathy and severity of nerve dysfunction as new-onset diabetes. Prediabetes, but not metabolic syndrome, was independently associated with both the presence of peripheral neuropathy and the severity of nerve dysfunction.
Background
Up to one‐third of Canadians are estimated to be living with prediabetes or diabetes. A retrospective study using Canadian private drug claims data was conducted to investigate whether ...flash glucose monitoring using the FreeStyle Libre system (FSL) among people with type 2 diabetes mellitus (T2DM) in Canada can be associated with changes in treatment intensification when compared with blood glucose monitoring (BGM) alone.
Materials and Methods
Using a Canadian national private drug claims database comprising approximately 50% coverage of insured individuals in Canada, cohorts of people with T2DM using FSL or BGM were identified algorithmically based on treatment history and followed over a 24‐month study period, tracking their progression in diabetes treatment therapy. The Andersen‐Gill model for recurrent time‐to‐event data was used to evaluate whether the rate of treatment progression differs between the FSL and BGM treatment cohorts. The survival function was used to calculate comparative treatment progression probabilities between the cohorts.
Results
In total, 373 871 people with T2DM met the inclusion criteria. Across treatment (FSL) and control (BGM) groups, people using FSL had a higher probability of treatment progression compared with BGM alone, with a relative risk ranging between 1.86 and 2.81 (p < .001). A higher probability of treatment progression was independent of the diabetes treatment at the enrolment date (index date) or the patient status, and independent of whether patients were treatment naïve or on established diabetes therapy. Assessment of the ending treatment relative to the starting therapy indicated that dynamic treatment changes were most evident for patients in the FSL cohort and that the FSL cohort had a much greater portion of patients who ended with insulin treatment (when they started with non‐insulin treatment) compared with the BGM cohort.
Conclusions
People with T2DM using FSL had a greater probability for treatment progression compared with BGM alone, irrespective of the starting therapy, which may suggest that FSL can be used to support escalation of diabetes therapy to improve therapeutic inertia in T2DM.
Achieving target glycaemic control is essential in people with diabetes to minimize the risk of long‐term complications, and many people with type 2 diabetes will ultimately require basal insulin ...(BI) therapy to achieve their individualized glycaemic targets. Usually, the first 12 weeks following initiation of BI therapy represents the period when the greatest dose increases and glycaemic reductions occur. Effective glycaemic control combined with minimizing the risk of hypoglycaemia is important to enable the achievement of glycaemic control in the longer term. However, substantial therapeutic inertia exists in clinical practice, both in initiation and up‐titration of BI, owing to patient‐, physician‐ and healthcare system‐related barriers, including fear of hypoglycaemia and the perception of a burdensome regimen. The more prolonged duration of action, reduced glycaemic variability and lower risk of hypoglycaemia seen with second‐generation versus first‐generation BI analogues may help alleviate patients’ and physicians’ concerns and facilitate titration. In turn, optimal BI titration and subsequent metabolic benefits may help improve therapy adherence and self‐management. This review details the clinical implications of prompt titration of BI to achieve early glycaemic control, and the importance of minimizing hypoglycaemia risk within the initial titration period. Facilitation of patients’ self‐management of BI is also addressed.
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