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SGLT-2 inhibitors are the first class of drugs to target renal glucose reabsorption as a means of reducing hyperglycemia in type 2 diabetes mellitus. Developed by a faculty of renowned, international diabetes experts led by Julio Rosenstock, MD, this 2-part educational activity will provide clinicians with an interpretation of recent clinical data, and explore the potential role of SGLT-2 inhibitors in diabetes care. This continuing medical education activity is jointly sponsored by Albert Einstein College of Medicine of Yeshiva University and Haymarket Medical Education and supported by an educational grant from Bristol-Myers Squibb.
The first component of this 2-part educational activity, the clinical monograph will provide endocrinologists, cardiologists, and general practitioners who manage the care of patients with type 2 diabetes with the latest data on the SGLT-2 inhibitors.
Four international diabetes experts will further elucidate the future role of the SGLT-2 inhibitors in the T2DM treatment arsenal.
Every patient with documented type 2 diabetes mellitus (T2DM) should have a comprehensive care plan (CCP), which takes into account the patient’s unique medical history, behaviors and risk factors, ethnocultural background, and environment. The multidisciplinary team typically oversees the medical management of T2DM, including the prescription of antihyperglycemic therapy and the delivery of diabetes self-management education (DSME).
Either the physician or a registered dietitian (RD) should discuss healthful eating recommendations in plain language at diagnosis of T2DM and then periodically during follow-up office visits (Table 1). MNT involves a more detailed discussion of calories, grams, and other metrics, as well as intensive implementation of dietary recommendations aimed at optimizing glycemic control and reducing the risk for complications.
Patients should be advised that any physical activity is better than none, and that they should make every effort to increase their activity level. An exercise prescription should be developed for each patient according to both goals and limitations. Antidiabetic treatment should be promptly intensified to maintain blood glucose at individual targets. Selection of agents should be based on individual patient medical history, behaviors, and risk factors, ethnocultural background, and environment. Self-monitoring of blood glucose (SMBG) is a vital tool for day-to-day management of blood sugar in all patients using insulin and many patients not using insulin. Most patients with an initial A1C level greater than 7.5% will require combination therapy using agents with complementary mechanisms of action. Antihyperglycemic agents may be broadly categorized by whether they predominantly target FPG or PPG levels (see Table 3). The choice of whether to target FPG or PPG should be based primarily on the individual patient’s glycemic profile obtained by self-monitoring of blood glucose (SMBG). Intensification of pharmacotherapy requires glucose monitoring and medication adjustment at appropriate intervals when treatment goals are not achieved or maintained. Long-acting basal insulin is generally the initial insulin choice, and the insulin analogues glargine and detemir are strongly preferred over human NPH insulin because they have relatively peakless time-action curves and a more consistent effect from day to day, resulting in a lower risk of hypoglycemia.
Basal insulin is usually added to existing noninsulin therapy, and many antihyperglycemic agents are approved for use with insulin: DPP-4 inhibitors, glinides, GLP-1 receptor agonists (but not exenatide XR), metformin, pramlintide, sulfonylureas, and TZDs.
The risk of hypoglycemia is increased when combining insulin with sulfonylureas, glinides, DPP-4 inhibitors, and GLP-1 receptor analogues. GLP-1 receptor analogues and DPP-4 inhibitors have not been studied with prandial insulin. Using insulin with TZDs may increase the risk of weight gain, edema, and congestive heart failure. Rapid-acting insulin analogues are preferred over regular human insulin because they have a more rapid onset and offset of action and are associated with less hypoglycemia. Premixed insulin analogue therapy may be considered for patients in whom drug regimen adherence is an issue; however, these preparations lack component dosage flexibility and may increase the risk for hypoglycemia compared with basal insulin or basal-bolus insulin. This approach (ie, transitioning to insulin after noninsulin agents fail to maintain glycemic targets) is supported by the recently published results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial.
Several new classes of agents are under investigation for the treatment of T2DM, and some new agents within existing classes may represent improvements over currently available options.17 The listing in Table 4 should be considered representative and not necessarily all-inclusive. For complete descriptions of the devices and accompanying technology themselves, click on the links above.
CSII is recommended mainly for patients with type 1 diabetes mellitus (T1DM), but patients with advanced T2DM who are absolutely insulin-deficient, take 4 or more insulin injections a day, and assess their blood glucose levels 4 or more times daily are candidates for CSII. Safety—particularly the risk of hypoglycemia—should be the primary concern when choosing an antidiabetic therapy. Table 3 lists the major safety risks associated with currently available antidiabetic agents.
Severe hypoglycemia stimulates sympathetic adrenergic discharge, causing arrhythmias or autonomic dysfunction (or both) and has long been recognized to have potential for causing mortality. In addition to increased mortality, hypoglycemia negatively affects adherence to therapy and quality of life and also contributes to morbidity. Management of hypoglycemia involves appropriate choice of antihyperglycemic therapy, tailoring of insulin treatment to minimize risks, and patient education in the recognition and treatment of acute hypoglycemia (Table 5).40 It is important to remember that the features listed in Table 5 occur along a continuum, and glycemic thresholds and symptom manifestations may vary widely among individuals. For T2DM patients, most of whom are overweight or obese, the risk of additional weight gain must be balanced against the benefits of the agent itself. Once T1DM and monogenic diabetes have been ruled out and a T2DM diagnosis has been definitively established for a child or adolescent, diet and lifestyle modification are always the first treatment choices.
Children born to women with any form of diabetes are at greater risk of developing T2DM themselves. Older adults are more likely to have an increased number of comorbid conditions (eg, frailty, dementia, depression, urinary incontinence) that can complicate their diabetes management.
Fasting is a common religious practice that can pose a challenge to diabetes management, particularly if the fast occurs over an extended time, such as Ramadan, a holy month of Islam in which all healthy adults consume no food or fluids between sunrise and sunset. The risk of these outcomes depends on the severity and complications of T2DM according to the categories in Table 7. For the management of glycemia during extended fasts, general principles and recommendations are listed below. Previous care or treatment: Patient has had multiple hospital admissions for acute exacerbation of systolic heart failure and respiratory distress secondary to fluid overload.

Impairments:Patient is lethargic and has difficulty breathing on minimal exertion (appears winded at rest).
Based on the patient's subjective and objective findings, patient's cardiopulmonary complications and co-morbidities have lead to an exacerbation of her CHF and hypokalemia in symptoms. Replace the potassium via IV, correct all the electrolyte abnormalities, and continue diuresis for fluid overload.
Deep breathing, postural drainage (precaution for pulmonary edema), percussion and vibration, strength and mobility exercises.
Due to muscle weakness and cramping, exercise is not effective during the initial state of hypokalemia. Patient is typically on bed rest by physician's order until Potassium levels have normalized. Phase 1 - Since patient is suffering from pulmonary edema secondary to acute hypoxic respiratory failure, physical therapy will assist pt on breathing exercises, postural drainage (precaution for PE), vibration and percussion. Phase 2 - Patient is classified as NYHA class 3 meaning patient has marked limitation of physical activity. Percussion and Vibration 3-5 minute per segment, perform on most congested area on first day. Strength: In-bed exercises to strengthen weakened muscles and increase blood flow throughout body.
According to the physician's recommendation, patient was treated with potassium chloride, magnesium sulfate, and lasix. Bed Mobility: Pt able to perform bed mobility transfers (rolling, sitting edge of bed, supine to side-lying to prone to side-lying and supine) in both directions independently. Transfers: Pt able to perform transfer from chair to bed and bed to chair with contact-guard assistance.
Posture: Pt's posture presents with forward-head and rounded shoulders, kyphotic posture noted. Static Stance: Pt able to stand for 25 seconds with contact-guard assistance before postural sway was noted. Ambulation: Pt able to ambulate 43 feet down the hall before becoming fatigued and HR increased by 15bpm.
Unless lab values are obtained, the presentation and diagnosis of hypokalemia can be hard to detect and differentially diagnose in some individuals.
Learn about the shoulder in this month's Physiopedia Plus learn topic with 5 chapters from textbooks such as Magee's Orthopedic Physical Assessment, 2014 & Donatelli's Physical therapy of the shoulder 2012. Emerging data strongly suggest that this novel drug class will, in the very near future, have a role to play in diabetes management. A detailed explanation of the unique mechanisms of action and the safety and tolerability profiles of this drug class will be provided, and the results of key clinical trials will be discussed.
The ultimate goal of the CCP is to reduce the risk of diabetes complications without jeopardizing patient safety. DSME is used to educate the patient on the components of therapeutic lifestyle changes, namely medical nutritional therapy (MNT) and physical activity.
These recommendations are suitable for the general population, including people without diabetes, and focus on foods that can promote health vs foods that may promote disease or complications from disease.
Recommendations should be personalized, and in general, evaluation and teaching should be conducted by an RD or knowledgeable physician. Overweight individuals with type 2 diabetes should strive for a 5% to 10% reduction in weight and should avoid weight gain. Unstructured activities include walking up or down stairs instead of using elevators, using parking spaces farther from building entrances, and the like.
Degludec, a new ultra-long–acting basal insulin, is currently undergoing review by the U.S. This 6-year study, which included over 12,000 patients, compared the use of insulin glargine with standard care in patients with cardiovascular risk factors plus either prediabetes or recent-onset T2DM (mean T2DM duration at baseline: 5 years). These patients must also be motivated to achieve tighter plasma glucose control and be intellectually and physically able to undergo the rigors of insulin pump therapy initiation and maintenance.
While individual agents may have contraindications or carry increased risks for specific populations, in general, hypoglycemia and weight gain are the primary limiting factors in diabetes treatment.
American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan.
Effects of aerobic and resistance training on hemoglobin A1C levels in patients with type 2 diabetes: a randomized controlled trial. Exercise training improves glycemic control in long-standing insulin-treated type 2 diabetic patients.
Continuous low- to moderate-intensity exercise training is as effective as moderate- to high-intensity exercise training at lowering blood HbA(1c) in obese type 2 diabetes patients.
Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes.
Lower baseline glycemia reduces apparent oral agent glucose-lowering efficacy: a meta-regression analysis.
Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes.
Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Renal sodium-glucose transport: role in diabetes mellitus and potential clinical implications. The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial.
Statement by the American Association of Clinical Endocrinologists Consensus Panel on insulin pump management.

Statement by the American Association of Clinical Endocrinologists Consensus Panel on continuous glucose monitoring. Benefits of self-monitoring blood glucose in the management of new-onset type 2 diabetes mellitus: the St Carlos Study, a prospective randomized clinic-based interventional study with parallel groups. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. ROSES: role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. Restoration of normal glucose tolerance in severely obese patients after bilio-pancreatic diversion: role of insulin sensitivity and beta cell function. The Diabetes Surgery Summit consensus conference: recommendations for the evaluation and use of gastrointestinal surgery to treat type 2 diabetes mellitus.
Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities.
The targeted interventions include replacing potassium via IV and monitor for other possible electrolyte imbalances. Physical therapists should be mindful of common signs of symptoms of hypokalemia when working with patients. After proper medical intervention is incorporated, muscle strength typically returns to normal. Before ambulating patient from bed, physical therapist will continue to monitor vitals throughout treatment session.
She is comfortable at rest but less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.[7] Physical therapy should be aware of these symptoms and get the patient out of bed to work on mobility. During this time physical therapy should work with patient everyday to improve their physical limitations while monitoring vitals and fatigue levels. Progress to longer distance and stairs while monitoring O2 sats and patient's fatigue levels.
After sitting and resting for two minutes pt was able to return to her room without any complications. Physiopedia is not a substitute for professional advice or expert medical services from a qualified healthcare provider.
Thus, it is important that health care providers who treat patients with diabetes are aware of the most recent data on these agents and the implications for clinical practice. Recommendations should be personalized on the basis of a patient’s specific medical conditions, lifestyle, and behavior.
To date, metformin remains the only oral medication approved by the FDA for use in children with T2DM.
She reports that she is currently unable to ambulate and has been feeling lethargic for three days.
Pt shows reliance of use with her accessory muscles to assist with breathing and has difficulty completing her sentences. The patient's diuretics should be monitored accordingly since it may lead to unwanted side effects such as this.
Therapist should address any impairments and functional deficits patient may display during treatment session. Physical therapy will monitor O2 sats before, during, and after the treatment sessions and patient will be able to rate their fatigue level on Perceive Level of Exertion Scale.
Patients unable to maintain a healthy weight on their own should be referred to an RD or weight-loss program that has a proven success rate.
Insulin use in the prediabetic patients did reduce the incidence of T2DM (see detailed discussion in Prediabetes), but there was no difference in cardiovascular outcomes between treatment groups after 6 years. According to her family, since her discharge from the hospital one month ago her respiratory status has not returned to normal.
The goal is to make patient euvolemic, and if the patient is unable to do so with diuretics a nephrologist should be consulted for possible for hemodialysis.
Since patient presents with respiratory insufficiency, PT is encouraged to perform exercises and educate patient on breathing exercises to improve oxygen consumption and energy conservation. Within a few hours after receiving the appropriate care, the patient's levels were able to normalize and previous strength was regained. Median FPG and A1C levels were lower in the glargine group, but the incidence of hypoglycemia and weight gain were modestly increased. She also reports having a history of muscle cramping in her lower leg but currently there is none present. Upon discharge the patient will need potassium supplements in accordance with her loop diuretic therapy. Hypokalemia also affects the respiratory system and can lead to shallow breathing and tachypnea which can be distressful to the patient.[2] With education, therapy, and proper medications the symptoms of hypokalemia should improve along with respiration. She has been using 2L of oxygen via nasal cannula and just a few days ago her Lasix dose was doubled to help manage her CHF symptoms.
She reports her quality of life has significantly declined in the last month and she now requires 24 hour assistance.

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