There has been an increase in the rate of diabetes for the past decade. Different methods and approaches were conducted to reduce its effect but there are variations in results. Clinical practice is needed to improve either the quality or process of care and patient outcomes. Clinicians and clinical managers need to choose from these numerous, sometimes differing, and occasionally contradictory, guidelines which are increasing on a regular basis (Beck et al., 2012). The quality of the given guideline is also one of the factors to be kept in mind. Every effort should be made to identify existing guidelines that have been rigorously developed and to adopt or adapt them for local use. Among all these guidelines we selected two guidelines which would be critically analysed, evaluated and compared.
The first guideline for diabetes monitoring is the use of intensive insulin therapy for the management of glycemic control in hospitalized patients and the second guideline for diabetes monitoring is oral pharmacologic treatment of type 2 diabetes mellitus.
A critical analysis was done of the two chosen guidelines using the Agree 11 tool. It was mainly done to check the quality of clinical practice guidelines (Bhatt et al., 2018). The Agree 11 tool had provided a set of twenty four questions and a marking scale out of seven was given to support whether the guidelines follow the given questions or not and give a critical analysis. Data were searched from different databases like MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Central Register of Controlled Trials, Turning research into practice (Trip) database, and the National Guideline Clearinghouse. The correlation coefficients of each domain was obtained by from the formula:
Domain Score Percentage = (Obtained score – Minimum possible score) / (Maximum score – Minimum possible score) * 100
In case of the use of intensive insulin therapy for the management of glycemic control in hospitalized patients, the correlation coefficients for the six domains were observed. The domain score for scope and purpose is 94 %, for stakeholder involvement is 44 %, for rigor of development is 79 %, for clarity of presentation is 67 %, for applicability is 33 % and editorial independence is 67 %. A few of the given guidelines had scored more than five in all six AGREE 11 domains (Brouwers et al., 2016). It has received minimum percentage for its applicability and stakeholders. Since it is new and many research works are going on, there are very few applications. Due to this reason, there are very few stakeholders as well. Most of the guidelines presented easily identifiable, specific key recommendations and different options for management of type 2 diabetes mellitus.
In case of the oral pharmacologic treatment of type 2 diabetes mellitus, the correlation coefficients for the six domains were observed. The domain score for scope and purpose is 94 %, for stakeholder involvement is 44 %, for rigor of development is 79 %, for clarity of presentation is 94 %, for applicability is 29 % and editorial independence is 75 %. A few of the given guidelines had scored more than six in all six AGREE 11 domains (Seto et al., 2017). Similar to the first guideline, it has also received less score for applicability and stakeholders. Research works are going on for this guidelines and very few have been successful to generate some applications. Stakeholders have also been found but are very less in number. Most of the guidelines presented showed specific key recommendations, easily identifiable and different options for management of type 2 diabetes mellitus.
As we can see that, the score in AGREE 11 tool for the oral pharmacologic treatment of type 2 diabetes mellitus is higher than the use of intensive insulin therapy for the management of glycemic control in hospitalized patients.
The American College of Physicians (ACP) conducted the method of intensive insulin therapy to provide evidence and link between intensive insulin therapy to achieve different glycemic targets and health outcomes of patients with type 2 diabetes mellitus (Qaseem et al., 2011). The method of intensive insulin therapy for the management of glycemic control in hospitalized patients identified the data from the article and literatures published in MEDLINE, Cochrane Library and few unpublished studies from ClinicalTrials.gov between 1950 to March 2009. Each article were reviewed from the eligibility criteria of type 2 diabetes mellitus patients who were hospitalised. The observations were short-term mortality and hypoglycemia.
There were three recommendations The American College of Physicians. The first recommendation was not to use insulin therapy to control glucose level in blood among patients in non–surgical intensive care unit (SICU)/medical intensive care unit (MICU). The grading system showed the recommendation to be strong and the quality of evidence to be moderate. The second recommendation was not to use insulin therapy to normalize glucose level in blood among patients in non–surgical intensive care unit (SICU)/medical intensive care unit (MICU). The grading system showed the recommendation to be strong and the quality of evidence to be of high (Guyatt et al., 2015). The third recommendation was to target blood glucose level of 7.8 to 11.1 mmol/L (140 to 200 mg/dL) if insulin therapy can be used in SICU/MICU patients. The grading system showed the recommendation to be weak and the quality of evidence to be moderate.
The American College of Physicians also developed the method of oral pharmacological treatment of type 2 diabetes. This guideline was developed to provide evidence based on clinical recommendations on the comparative effectiveness and safety of type 2 diabetes medications (Qaseem et al., 2012). The evidences were used from reviews and literatures published between 1966 to April 2010 from different databases like MEDLINE (updated through December 2010), EMBASE, and the Cochrane Central Register of Controlled Trials on type 2 diabetes mellitus. The outcomes included all-cause mortality, cardiovascular morbidity and mortality, cerebrovascular morbidity, neuropathy, nephropathy, and retinopathy.
The American College of Physicians came up with three recommendations. The first recommendation was inclusion of oral pharmacological therapies by clinicians for those who suffered from type 2 diabetes mellitus with changes in lifestyles including diet, exercise, and weight loss. The grading system showed the recommendation to be strong and the quality of evidence to be high. The second recommendation was prescribing monotherapy by clinicians with metformin for initial pharmacologic therapy to treat most patients with type 2 diabetes. The grading system showed the recommendation to be strong and the quality of evidence to be high. The third recommendation was the addition of a second agent to metformin in order to treat patients with persistent hyperglycemia when modification in lifestyle and metformin with monotherapy fail to control hyperglycemia. The grading system showed the recommendation to be strong and the quality of evidence to be high.
After comparing these two guidelines, it was found that the grading system showed that all three recommendations for oral pharmacological treatment of type 2 diabetes to be strong and quality of evidence to be high. While in case of intensive insulin therapy, the grading system showed that two of the given recommendations were strong and the other one is weak and the quality of evidence was high, moderate and weak for each of them.
In case of intensive insulin therapy and oral pharmacological treatment, the target audiences were internists, family physicians, hospitalists and clinicians for both. The interventions were adults with inpatient hyperglycemia and adults with type 2 diabetes respectively (Holmer et al., 2013). The outcome of intensive insulin therapy showed only mortality while oral pharmacological treatment showed all cause mortality, hemoglobin A1c levels, cardiovascular morbidity, mortality, weight, cerebrovascular morbidity, plasma lipid levels, neuropathy, nephropathy, retinopathy and the adverse effects.
Clinical considerations for guidelines intensive insulin therapy refers to
Patients with hyperglycemia
Patients who are critically ill and have high rate of mortality
Prevention of hyperglycemia was an important intervention and agreed by clinicians
Range of level of glucose is not accurate. Few studies showed that intensive insulin therapy improves mortality but patients receiving intensive insulin therapy showed no change in mortality and increased risk for hyperglycemia.
Clinical considerations for guidelines intensive insulin therapy refers to
Proper management of type 2 diabetes with therapies of both pharmacological and non pharmacological
Provides education to patients about treatment of hyperglycemia and reducing the cardiovascular and other risk factors and evaluating the data obtained
Non pharmacological therapies including modifications in diet, exercise regularly and loss of weight
Approaches for pharmacological therapy for management of type 2 diabetes when non pharmacological therapies fail
Metformin monotherapy reduces glycemic levels more than other monotherapies, as well as in combination therapy with a second agent. It reduces body weight and plasma lipid profile
Combination therapy can reduces hemoglobin A1c levels and has some effects
Comparing the clinical considerations, in case of intensive insulin therapy, it deals with more of hyperglycemia rather than diabetes. The considerations are also not conclusive and intensive insulin therapy showed no change in mortality rate but resulted in increase of the level of hyperglycemia. On the other hand in case of oral pharmacological treatment, it shows both pharmacological and non pharmacological approaches (Lenzer et al., 2013). It also initially focuses on non pharmacological approaches and when it fails, then it moves to pharmacological approaches.
The information provided from the reviews and literature in intensive insulin therapy shows limited results. It mainly focuses on hyperglycemia rather than type 2 diabetes and the evidence provided were also inconclusive. The outcome only provides information on mortality. It is also not able to provide the accurate range of level of glucose. It also provides with few studies where intensive insulin therapy reduces rate of mortality but in most cases, patients receiving intensive insulin therapy shows no change in rate of mortality and also increased the risk of hyperglycemia.
The information provided from the reviews and literature in oral pharmacological treatment shows information to an extent. It focuses on both pharmacological approaches as well as non pharmacological approaches. The outcomes are provided on a larger extent included all-cause mortality, cardiovascular morbidity and mortality, cerebrovascular morbidity, neuropathy, nephropathy, and retinopathy. It works on providing non pharmacological treatment to people suffering from type 2 diabetes like exercise, modification in diet and weight loss. If non pharmacological treatment fails then it focuses on the use of pharmacological treatment. It also gives an idea about metformin monotherapy which reduces glycemic levels more than other monotherapies, as well as in combination therapy with a second agent.
Conclusion
In comparing the two guidelines of clinical practice between intensive insulin therapy and oral pharmacological treatment in context to AGREE 11 and the guidelines, it has been found that oral pharmacological treatment has been better than intensive insulin therapy. Intensive insulin therapy provides limited results and inconclusive evidences. It mainly deals with hyperglycemia rather than type 2 diabetes. It is unable to provide the accurate level of glucose in blood. It only provides the outcome of mortality. It also provides with few studies where intensive insulin therapy reduces rate of mortality but in most cases, patients receiving intensive insulin therapy shows no change in rate of mortality and also increased the risk of hyperglycemia. Thus showing no conclusive evidence. On the other hand, oral pharmacological treatment shows evidences that are strong and of high quality but the information provided is to an extent. It focuses on both pharmacological approaches as well as non pharmacological approaches. The outcomes are provided on a larger extent included all-cause mortality, cardiovascular morbidity and mortality, cerebrovascular morbidity, neuropathy, nephropathy, and retinopathy. It initially focuses on non pharmacological approaches and when it fails, then it moves to pharmacological approaches. The evidences provided are much better than compared to intensive insulin therapy.
References
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