The Effect of Canagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, on Glycemic End Points Assessed by Continuous Glucose Monitoring and Patient-Reported Outcomes Among People With Type 1 Diabetes

Rodbard, Helena W.; Peters, Anne L.; Slee, April; Cao, Anjun; Traina, Shana; Alba, Maria

doi:10.2337/dc16-1353

Cited by 88 publications

(74 citation statements)

References 46 publications

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“…Today it is feasible to utilize CGM to compare treatment regimens with other interventions, other active agents, or placebo. This has been applied to rapid-acting 72,73 and long-acting 74 insulins, SGLT 2 inhibitors, 75 GLP-1 RAs, 72,76,77 and other classes 78 of medications. CGM is critical when we wish to compare GV for different forms of therapy, evaluate nocturnal patterns, frequency, severity, and duration of hypo-and hyperglycemia, and postprandial patterns.…”

Section: Impact Of Cgm On Clinical Trials Of New Therapeutic Agentsmentioning

confidence: 99%

“…It would be helpful if CE and FDA would make an unambiguous declaration that they will accept CGM data as part of the formal evaluation of new forms of therapy. The improving accuracy, ease of use, duration of use, user acceptance, reduced costs of CGM systems, and the success of studies reported to date [72][73][74][75][76][77][78] should spur increasing use of CGM in clinical trials.…”

Section: Impact Of Cgm On Clinical Trials Of New Therapeutic Agentsmentioning

confidence: 99%

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Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

Rodbard¹

2017

Diabetes Technology & Therapeutics

370

267

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Continuous Glucose Monitoring (CGM) has been demonstrated to be clinically valuable, reducing risks of hypoglycemia and hyperglycemia, glycemic variability (GV), and improving patient quality of life for a wide range of patient populations and clinical indications. Use of CGM can help reduce HbA1c and mean glucose. One CGM device, with accuracy (%MARD) of approximately 10%, has recently been approved for selfadjustment of insulin dosages (nonadjuvant use) and approved for reimbursement for therapeutic use in the United States. CGM had previously been used off-label for that purpose. CGM has been demonstrated to be clinically useful in both type 1 and type 2 diabetes for patients receiving a wide variety of treatment regimens. CGM is beneficial for people using either multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). CGM is used both in retrospective (professional, masked) and real-time (personal, unmasked) modes: both approaches can be beneficial. When CGM is used to suspend insulin infusion when hypoglycemia is detected until glucose returns to a safe level (low-glucose suspend), there are benefits beyond sensor-augmented pump (SAP), with greater reduction in the risk of hypoglycemia. Predictive low-glucose suspend provides greater benefits in this regard. Closed-loop control with insulin provides further improvement in quality of glycemic control. A hybrid closed-loop system has recently been approved by the U.S. FDA. Closed-loop control using both insulin and glucagon can reduce risk of hypoglycemia even more. CGM facilitates rigorous evaluation of new forms of therapy, characterizing pharmacodynamics, assessing frequency and severity of hypo-and hyperglycemia, and characterizing several aspects of GV.

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Section: Impact Of Cgm On Clinical Trials Of New Therapeutic Agentsmentioning

confidence: 99%

Section: Impact Of Cgm On Clinical Trials Of New Therapeutic Agentsmentioning

confidence: 99%

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

Rodbard¹

2017

Diabetes Technology & Therapeutics

370

267

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“…[5][6][7][8][9][10] Use of SGLT2 inhibitors was associated with improvements in average glucose control, reduced postprandial hyperglycemia and glycemic variability, reduced body weight, and reduced insulin dose requirements. [11][12][13] Dual SGLT1/2 inhibitor, sotagliflozin, has also demonstrated significant reductions in HbA1c, postprandial glucose, weight, and insulin doses.…”

Section: Discussionmentioning

confidence: 99%

Diabetic Ketoacidosis in a Patient with Type 1 Diabetes on Sodium-glucose Co-transporter-2 Inhibitors—a Case Report

Priya¹,

Bhambri²

2017

US Endocrinology

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W e describe a case of a 26-year-old female with long-standing type 1 diabetes (T1D), on multiple subcutaneous insulin injections, who had been taking empagliflozin for the past year. She was detected to have severe diabetic ketoacidosis (DKA) with relatively lower blood glucose values during hospitalisation for dengue fever. The factors that precipitated the DKA are discussed, along with the unique challenges in the management of her metabolic status. While sodium-glucose co-transporter-2 (SGLT2) inhibitors have several potential benefits as adjunctive add-on therapy to insulin in T1D, the evidence is limited to short-term studies. However, their off-label use is increasing and there have been concerns related to increased risk of diabetic ketoacidosis. At present, SGLT2 inhibitors are not approved for use in T1D, and the risks should be discussed at length with the patient. KeywordsType 1 diabetes, diabetic ketoacidosis, euglycaemic diabetic ketoacidosis, sodium-glucose co-transporter-2 (SGLT2) inhibitors, empagliflozin Disclosure: Gagan Priya and Vishal Bhambri have nothing to declare in relation to this article. No funding was received in the publication of this article.Compliance with Ethics: All procedures were followed in accordance with the responsible committee on human experimentation and with the Helsinki Declaration of 1975 and subsequent revisions, and informed consent was received from the patient involved in this case study.Authorship: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published.Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. We report a case of diabetic ketoacidosis in a 26-year-old female with long-standing type 1 diabetes (T1D) who was on multiple subcutaneous insulin injections and empagliflozin. Informed consent was taken from the patient for the publication of this report. Case reportA 26-year-old female, a postgraduate student, with long-standing T1D since the age of 10 presented to the emergency department on the evening of July 2017 with a history of fever for 4 days and a petechial rash over the trunk and upper arms for 2 days. She complained of malaise and loss of appetite but there was no history of rigors or chills, dysuria, diarrhea, vomiting, abdominal discomfort or respiratory difficulty. At presentation, she was conscious and well-oriented and had a fever (temperature 99.8°F), her vitals were stable and she had no hypotension. She had a petechial rash on the upper body and an extensive genital and inguinal mycotic infection, but the rest of the systemic examination was otherwise normal.For her diabetes, she had been taking multiple subcutaneous insulin injections for severa...

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“…The use of these drugs appears to be increasing in young people with T1D despite not being approved 1,[27][28][29][30] . This case illustrates the risk of using these promising drugs when long-term safety studies are lacking.…”

Section: Discussionmentioning

confidence: 99%

Cetosis normoglicémica en adolescente con diabetes tipo 1 recibiendo insulina y dapaglifozina: Reporte de un caso

Ramírez

Román

2017

Rev. chil. pediatr.

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Introduction: Dapagliflozin, an insulin-independent sodium-glucose cotransporter 2 inhibitor (SGLT2-I) induces glycosuria and reduces hyperglycemia in adults with type 2 diabetes. Objective: To present an "euglycemic" diabetic ketosis in an adolescent with type 1 diabetes (T1D) receiving dapagliflozin, to alert about the risk of a drug not approved in children nor in T1D. Case report: A 17 years old adolescent with T1D during 9 years, was started on dapagliflozin 10 mg/day to reduce insulin dose and weight. During 11 months on treatment, capillary ketones were undetectable and she exhibited a reduction in body mass index 23.9 to 21.1 kg/m 2 , basal insulin 40 to 17 U, glycated hemoglobin 8.3 to 7.5%, capillary glucose 175 to 161 mg/dl and glucose variability (standard deviation) 85 to 77. Suddenly nausea and vomits appeared. The patient was on an insulin pump and well calibrated continuous glucose monitoring, showing stable glucose levels under 200 mg/dl, and an insulin bolus was delivered. Vomiting without hyperglycemia persisted; three hours later, she was severely dehydrated and fainting, with ketones 4.6 nmol/l and glucose 224 mg/dl. She received IV saline fluids, ondansetron, carbohydrates and several insulin boluses. Hydration and general condition improved soon, however despite several insulin doses, ketosis continued for 24 hours. It is remarkable that the pump was working well and the cannula was not changed. After the ketosis was resolved, she continued using the same cannula with good metabolic control. Conclusion: Euglycemic ketosis is a life-threatening condition that must be suspected.

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The Effect of Canagliflozin, a Sodium Glucose Cotransporter 2 Inhibitor, on Glycemic End Points Assessed by Continuous Glucose Monitoring and Patient-Reported Outcomes Among People With Type 1 Diabetes

Cited by 88 publications

References 46 publications

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes

Diabetic Ketoacidosis in a Patient with Type 1 Diabetes on Sodium-glucose Co-transporter-2 Inhibitors—a Case Report

Cetosis normoglicémica en adolescente con diabetes tipo 1 recibiendo insulina y dapaglifozina: Reporte de un caso

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