When Will the Standards of Care Change?
Aug 18, 2017 22:45:39 GMT -5
saxcmann, comnkd, and 3 more like this
Post by mango on Aug 18, 2017 22:45:39 GMT -5
What is it going to take to help PWD? When will the American Diabetes Association change the Standards of Care based on common sense, logic, reason, health, and care? This frustrates me to no end.
Do we need to establish a new, alternative to the ADA to better help people with diabetes? Many PWD need help, but they can't get it: Pharma, PBMs, Insurance, the FDA, and entities like that of American Diabetes Association's Professional Practice Committee suppresses new technologies and innovations and sacrifices people's health over biasnees and greed.
There is clearly two entirely different ways of thinking going on in diabetes medical care right now, and I cannot see a natural bridge being made between the two. The ADA stands behind the Standards of Care and these official stances and guidelines and recommendations influence medical decision making and directly impact lives. These Standards of Care have proven to be a failure. I simply cannot grasp how a group of people could be so foolish. What is going on? What is wrong with the ADA? I think an alternate entity needs to be established to better care for the people in this country, and breaking the monopoly of the Standards of Care which regulate diabetes care is a good starting point, IMO.
Standards of Medical Care in Diabetes—2017: Summary of Revisions
Section 5. Prevention or Delay of Type 2 Diabetes
To help providers identify those patients who would benefit from prevention efforts, new text was added emphasizing the importance of screening for prediabetes using an assessment tool or informal assessment of risk factors and performing a diagnostic test when appropriate. To reflect new evidence showing an association between B12 deficiency and long-term metformin use, a recommendation was added to consider periodic measurement of B12 levels and supplementation as needed.
Section 8.
Pharmacologic Approaches to Glycemic Treatment
The title of this section was changed from “Approaches to Glycemic Treatment” to “Pharmacologic Approaches to Glycemic Treatment” to reinforce that the section focuses on pharmacologic therapy alone. Lifestyle management and obesity management are discussed in separate chapters.
• To reflect new evidence showing an association between B12 deficiency and long-term metformin use, a recommendation was added to consider periodic measurement of B12 levels and supplementation as needed.
Section 13. Management of Diabetes in Pregnancy
Insulin was emphasized as the treatment of choice in pregnancy based on concerns about the concentration of metformin on the fetal side of the placenta and glyburide levels in cord blood.
Based on available data, preprandial self-monitoring of blood glucose was deemphasized in the management of diabetes in pregnancy.
In the interest of simplicity, fasting and postprandial targets for pregnant women with gestational diabetes mellitus and preexisting diabetes were unified.
PHARMACOLOGIC THERAPY FOR TYPE 2 DIABETES
Recommendations
• Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacologic agent for the treatment of type 2 diabetes. Long-term use of metformin may be associated with biochemical vitamin B12 deficiency, and periodic measurement of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy.
• The use of metformin as first-line therapy was supported by findings from a large meta-analysis, with selection of second-line therapies based on patient-specific considerations (20). An ADA/European Association for the Study of Diabetes position statement (21) recommended a patient-centered approach, including assessment of efficacy, hypoglycemia risk, impact on weight, side effects, costs, and patient preferences. Renal effects may also be con- sidered when selecting glucose-lowering medications for individual patients. Life- style modifications that improve health (see Section 4 “Lifestyle Management”) should be emphasized along with any pharmacologic therapy.
• Initial Therapy
Metformin monotherapy should be started at diagnosis of type 2 diabetes unless there are contraindications. Metformin is effective and safe, is inexpensive, and may reduce risk of cardiovascular events and death (22). Metformin may be safely used in patients with estimated glomerular filtration rate (eGFR) as low as 30 mL/min/1.73 m2 (23), and the U.S. label for metformin was recently revised to reflect its safety in patients with eGFR greater than or less than 30 mL/min/1.73 m2 (24).
Patients should be advised to stop the medication in cases of nausea, vomiting, or dehydration. Metformin is associated with vitamin B12 deficiency, with a recent report from the Diabetes Prevention Program Outcomes Study (DPPOS) suggesting that periodic testing of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy (25).
In patients with metformin contraindications or intolerance, consider an initial drug from another class depicted in Fig. 8.1 under “Dual Therapy” and proceed accordingly. When A1C is equal to or greater than 9% (75 mmol/mol), consider initiating dual combination therapy (Fig. 8.1) to more expeditiously achieve the target A1C level. Insulin has the advantage of being effective where other agents may not be and should be considered as part of any combination regimen when hyperglycemia is severe, especially if symptoms are present or any catabolic features (weight loss, ketosis) are present. Consider initiating combination insulin injectable therapy (Fig. 8.2) when blood glucose is equal to or greater than 300 mg/dL (16.7 mmol/L) or A1C is $10% (86 mmol/mol) or if the patient has symptoms of hyperglycemia (i.e., polyuria or polydipsia). As the patient’s glucose toxicity resolves, the regimen may, potentially, be simplified.
• Reference #20:
Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in
Patients With Type 2 Diabetes
A Meta-analysis
Conclusions and Relevance
Among adults with type 2 diabetes, there were no significant differences in the associations between any of 9 available classes of glucose-lowering drugs (alone or in combination) and the risk of cardiovascular or all-cause mortality. Metformin was associated with lower or no significant difference in HbA1C levels compared with any other drug classes. All drugs were estimated to be effective when added to metformin. These findings are consistent with American Diabetes Association recommendations for using metformin monotherapy as initial treatment for patients with type 2 diabetes and selection of additional therapies based on patient-specific considerations.
Authors
Palmer SC1, Mavridis D2, Nicolucci A3, Johnson DW4, Tonelli M5, Craig JC6, Maggo J1, Gray V1, De Berardis G3, Ruospo M7, Natale P8, Saglimbene V8, Badve SV9, Cho Y10, Nadeau-Fredette AC11, Burke M4, Faruque L12, Lloyd A13, Ahmad N13, Liu Y13, Tiv S13, Wiebe N13, Strippoli GF14.
Author information
• 1Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand.
• 2Department of Primary Education, School of Education, University of Ioannina, University Campus, Dourouti, Ioannina, Greece3Department of Hygiene and Epidemiology, School of Health Sciences, University of Ioannina, University Campus, Dourouti, Ioannina, G.
• 3Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.
• 4Division of Medicine, Department of Renal Medicine, University of Queensland at the Princess Alexandra Hospital, Woolloongabba, Australia6Translational Research Institute, University of Queensland, Woolloongabba, Australia.
• 5Cumming School of Medicine, Health Sciences Centre, University of Calgary, Foothills Campus, Calgary, Alberta, Canada.
• 6Sydney School of Public Health, University of Sydney, Sydney, Australia.
• 7Division of Nephrology and Transplantation, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy10Diaverum Medical Scientific Office, Lund, Sweden.
• 8Diaverum Medical Scientific Office, Lund, Sweden.
• 9Division of Medicine, Department of Renal Medicine, University of Queensland at the Princess Alexandra Hospital, Woolloongabba, Australia11The George Institute for Global Health, Sydney, Australia.
• 10Division of Medicine, Department of Renal Medicine, University of Queensland at the Princess Alexandra Hospital, Woolloongabba, Australia.
• 11Nephrology Division, Department of Medicine, University of Montreal, Montreal, Quebec, Canada.
• 12Department of Medicine, Royal Alexandra Hospital, Edmonton, Alberta, Canada.
• 13Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
• 14Sydney School of Public Health, University of Sydney, Sydney, Australia10Diaverum Medical Scientific Office, Lund, Sweden15Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Standards of Medical Care in Diabetes—2017: Summary of Revisions
American Diabetes Association Standards of Medical Care in Diabetes—2017
Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in Patients With Type 2 Diabetes A Meta-analysis
• The ADA states:
• This is the support and reasoning for the ADA to conclude this should be a first-line therapy, and also a tag along therapy. This is the most foolish thing I have ever read. There was no significant results, and there is absolutely no findings to suggest it should even be a therapy at all. Are they mentally sound to even make wise decisions for themselves? We need this investigated. These people are a liability for having good health.
I am truly at a loss for words at this point. Every single time I read this stuff. I have never in my life seen so many contradictory, ignorant, biased, irresponsible and harmful medical recommendations and statements. The ADA, AACE, and the ACE all have supreme authority, they are the ones regulating people's health here based off of things that just make no sense at all.
This has to stop. No one in their right mind can tell me this is responsible behavior, sound judgment and good thinking skills.
The needless suffering needs to end.
When will the Standards of Medical Care in Diabetes change?
Glucose Homeostasis:
Homeostatic Disruptor:
Do we need to establish a new, alternative to the ADA to better help people with diabetes? Many PWD need help, but they can't get it: Pharma, PBMs, Insurance, the FDA, and entities like that of American Diabetes Association's Professional Practice Committee suppresses new technologies and innovations and sacrifices people's health over biasnees and greed.
There is clearly two entirely different ways of thinking going on in diabetes medical care right now, and I cannot see a natural bridge being made between the two. The ADA stands behind the Standards of Care and these official stances and guidelines and recommendations influence medical decision making and directly impact lives. These Standards of Care have proven to be a failure. I simply cannot grasp how a group of people could be so foolish. What is going on? What is wrong with the ADA? I think an alternate entity needs to be established to better care for the people in this country, and breaking the monopoly of the Standards of Care which regulate diabetes care is a good starting point, IMO.
Standards of Medical Care in Diabetes—2017: Summary of Revisions
Section 5. Prevention or Delay of Type 2 Diabetes
To help providers identify those patients who would benefit from prevention efforts, new text was added emphasizing the importance of screening for prediabetes using an assessment tool or informal assessment of risk factors and performing a diagnostic test when appropriate. To reflect new evidence showing an association between B12 deficiency and long-term metformin use, a recommendation was added to consider periodic measurement of B12 levels and supplementation as needed.
Section 8.
Pharmacologic Approaches to Glycemic Treatment
The title of this section was changed from “Approaches to Glycemic Treatment” to “Pharmacologic Approaches to Glycemic Treatment” to reinforce that the section focuses on pharmacologic therapy alone. Lifestyle management and obesity management are discussed in separate chapters.
• To reflect new evidence showing an association between B12 deficiency and long-term metformin use, a recommendation was added to consider periodic measurement of B12 levels and supplementation as needed.
Section 13. Management of Diabetes in Pregnancy
Insulin was emphasized as the treatment of choice in pregnancy based on concerns about the concentration of metformin on the fetal side of the placenta and glyburide levels in cord blood.
Based on available data, preprandial self-monitoring of blood glucose was deemphasized in the management of diabetes in pregnancy.
In the interest of simplicity, fasting and postprandial targets for pregnant women with gestational diabetes mellitus and preexisting diabetes were unified.
PHARMACOLOGIC THERAPY FOR TYPE 2 DIABETES
Recommendations
• Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacologic agent for the treatment of type 2 diabetes. Long-term use of metformin may be associated with biochemical vitamin B12 deficiency, and periodic measurement of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy.
• The use of metformin as first-line therapy was supported by findings from a large meta-analysis, with selection of second-line therapies based on patient-specific considerations (20). An ADA/European Association for the Study of Diabetes position statement (21) recommended a patient-centered approach, including assessment of efficacy, hypoglycemia risk, impact on weight, side effects, costs, and patient preferences. Renal effects may also be con- sidered when selecting glucose-lowering medications for individual patients. Life- style modifications that improve health (see Section 4 “Lifestyle Management”) should be emphasized along with any pharmacologic therapy.
• Initial Therapy
Metformin monotherapy should be started at diagnosis of type 2 diabetes unless there are contraindications. Metformin is effective and safe, is inexpensive, and may reduce risk of cardiovascular events and death (22). Metformin may be safely used in patients with estimated glomerular filtration rate (eGFR) as low as 30 mL/min/1.73 m2 (23), and the U.S. label for metformin was recently revised to reflect its safety in patients with eGFR greater than or less than 30 mL/min/1.73 m2 (24).
Patients should be advised to stop the medication in cases of nausea, vomiting, or dehydration. Metformin is associated with vitamin B12 deficiency, with a recent report from the Diabetes Prevention Program Outcomes Study (DPPOS) suggesting that periodic testing of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy (25).
In patients with metformin contraindications or intolerance, consider an initial drug from another class depicted in Fig. 8.1 under “Dual Therapy” and proceed accordingly. When A1C is equal to or greater than 9% (75 mmol/mol), consider initiating dual combination therapy (Fig. 8.1) to more expeditiously achieve the target A1C level. Insulin has the advantage of being effective where other agents may not be and should be considered as part of any combination regimen when hyperglycemia is severe, especially if symptoms are present or any catabolic features (weight loss, ketosis) are present. Consider initiating combination insulin injectable therapy (Fig. 8.2) when blood glucose is equal to or greater than 300 mg/dL (16.7 mmol/L) or A1C is $10% (86 mmol/mol) or if the patient has symptoms of hyperglycemia (i.e., polyuria or polydipsia). As the patient’s glucose toxicity resolves, the regimen may, potentially, be simplified.
• Reference #20:
Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in
Patients With Type 2 Diabetes
A Meta-analysis
Conclusions and Relevance
Among adults with type 2 diabetes, there were no significant differences in the associations between any of 9 available classes of glucose-lowering drugs (alone or in combination) and the risk of cardiovascular or all-cause mortality. Metformin was associated with lower or no significant difference in HbA1C levels compared with any other drug classes. All drugs were estimated to be effective when added to metformin. These findings are consistent with American Diabetes Association recommendations for using metformin monotherapy as initial treatment for patients with type 2 diabetes and selection of additional therapies based on patient-specific considerations.
Authors
Palmer SC1, Mavridis D2, Nicolucci A3, Johnson DW4, Tonelli M5, Craig JC6, Maggo J1, Gray V1, De Berardis G3, Ruospo M7, Natale P8, Saglimbene V8, Badve SV9, Cho Y10, Nadeau-Fredette AC11, Burke M4, Faruque L12, Lloyd A13, Ahmad N13, Liu Y13, Tiv S13, Wiebe N13, Strippoli GF14.
Author information
• 1Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand.
• 2Department of Primary Education, School of Education, University of Ioannina, University Campus, Dourouti, Ioannina, Greece3Department of Hygiene and Epidemiology, School of Health Sciences, University of Ioannina, University Campus, Dourouti, Ioannina, G.
• 3Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.
• 4Division of Medicine, Department of Renal Medicine, University of Queensland at the Princess Alexandra Hospital, Woolloongabba, Australia6Translational Research Institute, University of Queensland, Woolloongabba, Australia.
• 5Cumming School of Medicine, Health Sciences Centre, University of Calgary, Foothills Campus, Calgary, Alberta, Canada.
• 6Sydney School of Public Health, University of Sydney, Sydney, Australia.
• 7Division of Nephrology and Transplantation, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy10Diaverum Medical Scientific Office, Lund, Sweden.
• 8Diaverum Medical Scientific Office, Lund, Sweden.
• 9Division of Medicine, Department of Renal Medicine, University of Queensland at the Princess Alexandra Hospital, Woolloongabba, Australia11The George Institute for Global Health, Sydney, Australia.
• 10Division of Medicine, Department of Renal Medicine, University of Queensland at the Princess Alexandra Hospital, Woolloongabba, Australia.
• 11Nephrology Division, Department of Medicine, University of Montreal, Montreal, Quebec, Canada.
• 12Department of Medicine, Royal Alexandra Hospital, Edmonton, Alberta, Canada.
• 13Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
• 14Sydney School of Public Health, University of Sydney, Sydney, Australia10Diaverum Medical Scientific Office, Lund, Sweden15Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Standards of Medical Care in Diabetes—2017: Summary of Revisions
American Diabetes Association Standards of Medical Care in Diabetes—2017
Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in Patients With Type 2 Diabetes A Meta-analysis
• The ADA states:
The use of metformin as first-line therapy was supported by findings from a large meta-analysis, with selection of second-line therapies based on patient-specific considerations (20).
Results
A total of 301 clinical trials (1 417 367 patient-months) were included; 177 trials (56 598 patients) of drugs given as monotherapy; 109 trials (53 030 patients) of drugs added to metformin (dual therapy); and 29 trials (10 598 patients) of drugs added to metformin and sulfonylurea (triple therapy). There were no significant differences in associations between any drug class as monotherapy, dual therapy, or triple therapy with odds of cardiovascular or all-cause mortality. Compared with metformin, sulfonylurea (standardized mean difference [SMD], 0.18 [95% CI, 0.01 to 0.34]), thiazolidinedione (SMD, 0.16 [95% CI, 0.00 to 0.31]), DPP-4 inhibitor (SMD, 0.33 [95% CI, 0.13 to 0.52]), and α-glucosidase inhibitor (SMD, 0.35 [95% CI, 0.12 to 0.58]) monotherapy were associated with higher HbA1C levels. Sulfonylurea (odds ratio [OR], 3.13 [95% CI, 2.39 to 4.12]; risk difference [RD], 10% [95% CI, 7% to 13%]) and basal insulin (OR, 17.9 [95% CI, 1.97 to 162]; RD, 10% [95% CI, 0.08% to 20%]) were associated with greatest odds of hypoglycemia. When added to metformin, drugs were associated with similar HbA1C levels, while SGLT-2 inhibitors offered the lowest odds of hypoglycemia (OR, 0.12 [95% CI, 0.08 to 0.18]; RD, −22% [−27% to −18%]). When added to metformin and sulfonylurea, GLP-1 receptor agonists were associated with the lowest odds of hypoglycemia (OR, 0.60 [95% CI, 0.39 to 0.94]; RD, −10% [95% CI, −18% to −2%]).
A total of 301 clinical trials (1 417 367 patient-months) were included; 177 trials (56 598 patients) of drugs given as monotherapy; 109 trials (53 030 patients) of drugs added to metformin (dual therapy); and 29 trials (10 598 patients) of drugs added to metformin and sulfonylurea (triple therapy). There were no significant differences in associations between any drug class as monotherapy, dual therapy, or triple therapy with odds of cardiovascular or all-cause mortality. Compared with metformin, sulfonylurea (standardized mean difference [SMD], 0.18 [95% CI, 0.01 to 0.34]), thiazolidinedione (SMD, 0.16 [95% CI, 0.00 to 0.31]), DPP-4 inhibitor (SMD, 0.33 [95% CI, 0.13 to 0.52]), and α-glucosidase inhibitor (SMD, 0.35 [95% CI, 0.12 to 0.58]) monotherapy were associated with higher HbA1C levels. Sulfonylurea (odds ratio [OR], 3.13 [95% CI, 2.39 to 4.12]; risk difference [RD], 10% [95% CI, 7% to 13%]) and basal insulin (OR, 17.9 [95% CI, 1.97 to 162]; RD, 10% [95% CI, 0.08% to 20%]) were associated with greatest odds of hypoglycemia. When added to metformin, drugs were associated with similar HbA1C levels, while SGLT-2 inhibitors offered the lowest odds of hypoglycemia (OR, 0.12 [95% CI, 0.08 to 0.18]; RD, −22% [−27% to −18%]). When added to metformin and sulfonylurea, GLP-1 receptor agonists were associated with the lowest odds of hypoglycemia (OR, 0.60 [95% CI, 0.39 to 0.94]; RD, −10% [95% CI, −18% to −2%]).
Conclusions and Relevance
Among adults with type 2 diabetes, there were no significant differences in the associations between any of 9 available classes of glucose-lowering drugs (alone or in combination) and the risk of cardiovascular or all-cause mortality. Metformin was associated with lower or no significant difference in HbA1C levels compared with any other drug classes. All drugs were estimated to be effective when added to metformin. These findings are consistent with American Diabetes Association recommendations for using metformin monotherapy as initial treatment for patients with type 2 diabetes and selection of additional therapies based on patient-specific considerations.
Among adults with type 2 diabetes, there were no significant differences in the associations between any of 9 available classes of glucose-lowering drugs (alone or in combination) and the risk of cardiovascular or all-cause mortality. Metformin was associated with lower or no significant difference in HbA1C levels compared with any other drug classes. All drugs were estimated to be effective when added to metformin. These findings are consistent with American Diabetes Association recommendations for using metformin monotherapy as initial treatment for patients with type 2 diabetes and selection of additional therapies based on patient-specific considerations.
Key Points
Question
What are the most effective medical treatments for type 2 diabetes?
Findings
In this systematic review with network meta-analysis, risks of cardiovascular and all-cause mortality were not different between any glucose-lowering drugs alone or in combination. Metformin was associated with lower or similar HbA1C levels compared with all other drugs given as monotherapy. All drugs were estimated to be effective when added to metformin.
Question
What are the most effective medical treatments for type 2 diabetes?
Findings
In this systematic review with network meta-analysis, risks of cardiovascular and all-cause mortality were not different between any glucose-lowering drugs alone or in combination. Metformin was associated with lower or similar HbA1C levels compared with all other drugs given as monotherapy. All drugs were estimated to be effective when added to metformin.
I am truly at a loss for words at this point. Every single time I read this stuff. I have never in my life seen so many contradictory, ignorant, biased, irresponsible and harmful medical recommendations and statements. The ADA, AACE, and the ACE all have supreme authority, they are the ones regulating people's health here based off of things that just make no sense at all.
This has to stop. No one in their right mind can tell me this is responsible behavior, sound judgment and good thinking skills.
The needless suffering needs to end.
When will the Standards of Medical Care in Diabetes change?
Glucose Homeostasis:
Homeostatic Disruptor:
