scholarly journals Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies

2020 ◽  
Author(s):  
Anne L. Peters ◽  
Darren K. McGuire ◽  
Thomas Danne ◽  
Jake A. Kushner ◽  
Helena W. Rodbard ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Risk Mitigation ◽  
Pooled Analysis ◽  
Once Daily ◽  
Adjusted Incidence Rate ◽  
Beta Hydroxybutyrate ◽  
Design And Methods ◽  
Adjusted Incidence

<b>Objective: </b>To evaluate incidence and risk factors for diabetic ketoacidosis (DKA) and related adverse events (AEs) in adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin. <p><b>Research Design and Methods: </b>Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in beta-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L; patients were administered placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily. </p> <p><b>Results:</b> A total of 191 ketosis-related AEs were reported; 98 underwent adjudication. Of these, 37 (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg. No patient died from a DKA event. From a baseline BHB of ~0.13 mmol/L, sotagliflozin treatment led to a small median increase over 52 weeks (≤0.05 mmol/L at all time points). Approximately 47% and 7% of sotagliflozin-treated patients had ≥1 BHB measurement >0.6 mmol/L and >1.5 mmol/L (vs 20% and 2% of placebo-treated patients). Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus pre-implementation in both the sotagliflozin 200-mg and 400-mg groups. </p> <p><b>Conclusion:</b> In patients with type 1 diabetes, confirmed DKA incidence increased when sotagliflozin was added to insulin compared with insulin alone. A lower incidence of DKA was observed following the implementation of an enhanced risk mitigation plan, suggesting that this risk can be managed with patient education.</p>

scholarly journals Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies

2020 ◽  
Author(s):  
Anne L. Peters ◽  
Darren K. McGuire ◽  
Thomas Danne ◽  
Jake A. Kushner ◽  
Helena W. Rodbard ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Risk Mitigation ◽  
Pooled Analysis ◽  
Once Daily ◽  
Adjusted Incidence Rate ◽  
Beta Hydroxybutyrate ◽  
Design And Methods ◽  
Adjusted Incidence

<b>Objective: </b>To evaluate incidence and risk factors for diabetic ketoacidosis (DKA) and related adverse events (AEs) in adults with type 1 diabetes treated with sotagliflozin adjunctive to insulin. <p><b>Research Design and Methods: </b>Data from two identically designed, 52-week, randomized studies were pooled and analyzed for DKA, changes in beta-hydroxybutyrate (BHB), and percentage of patients with BHB >0.6 and >1.5 mmol/L; patients were administered placebo, sotagliflozin 200 mg, or sotagliflozin 400 mg once daily. </p> <p><b>Results:</b> A total of 191 ketosis-related AEs were reported; 98 underwent adjudication. Of these, 37 (36 patients) were adjudicated as DKA, with an exposure-adjusted incidence rate of 0.2, 3.1, and 4.2 events per 100 patient-years for placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg. No patient died from a DKA event. From a baseline BHB of ~0.13 mmol/L, sotagliflozin treatment led to a small median increase over 52 weeks (≤0.05 mmol/L at all time points). Approximately 47% and 7% of sotagliflozin-treated patients had ≥1 BHB measurement >0.6 mmol/L and >1.5 mmol/L (vs 20% and 2% of placebo-treated patients). Subsequent to the implementation of a risk mitigation plan, annualized DKA incidence was lower versus pre-implementation in both the sotagliflozin 200-mg and 400-mg groups. </p> <p><b>Conclusion:</b> In patients with type 1 diabetes, confirmed DKA incidence increased when sotagliflozin was added to insulin compared with insulin alone. A lower incidence of DKA was observed following the implementation of an enhanced risk mitigation plan, suggesting that this risk can be managed with patient education.</p>

scholarly journals Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies

Diabetes Care ◽  
2020 ◽  
Vol 43 (11) ◽  
pp. 2713-2720 ◽  
Author(s):  
Anne L. Peters ◽  
Darren K. McGuire ◽  
Thomas Danne ◽  
Jake A. Kushner ◽  
Helena W. Rodbard ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Pooled Analysis

scholarly journals Differentiating Diabetic Ketoacidosis and Hyperglycemic Ketosis Due to Cannabis Hyperemesis Syndrome in Adults With Type 1 Diabetes

2021 ◽  
Author(s):  
Halis Kaan Akturk ◽  
Janet Snell-Bergeon ◽  
Gregory L Kinney ◽  
Anagha Champakanath ◽  
Andrew Monte ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Mixed Models ◽  
Operating Characteristic ◽  
Cannabis Use ◽  
Urine Test ◽  
Icd 10 ◽  
Design And Methods ◽  
Cannabis Hyperemesis Syndrome

<b>Objective</b> <p>To differentiate diabetic ketoacidosis (DKA) from hyperglycemic ketosis due to cannabis hyperemesis syndrome (HK-CHS) in adults with type 1 diabetes.</p> <p><b>Research Design and Methods</b></p> <p>Of 295 adults with type 1 diabetes who were seen with DKA related ICD-10 codes, 68 patients with 172 DKA events meeting the inclusion criteria were analyzed. Cannabis use was defined as positive urine test for cannabis. Linear mixed models were used to define HK-CHS (pH ≥7.4 with bicarbonate ≥ 15) and sensitivity and specificity were calculated using receiver operating characteristic (ROC).</p> <p><b>Results</b></p> <p>Cannabis users had significantly higher pH (7.42 ± 0.01 vs 7.09 ± 0.02) and bicarbonate (19.2 ± 0.61 vs 9.1 ± 0.71) (p<0.0001) compared to non-users. The area under the ROC for positive cannabis urine test predicting HK-CHS was 0.9892.</p> <p><b>Conclusions</b></p> <p>In patients who present with DKA and higher pH, especially pH ≥ 7.4, cannabis use should be considered in differential diagnosis.</p>

scholarly journals Differentiating Diabetic Ketoacidosis and Hyperglycemic Ketosis Due to Cannabis Hyperemesis Syndrome in Adults With Type 1 Diabetes

2021 ◽  
Author(s):  
Halis Kaan Akturk ◽  
Janet Snell-Bergeon ◽  
Gregory L Kinney ◽  
Anagha Champakanath ◽  
Andrew Monte ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Mixed Models ◽  
Operating Characteristic ◽  
Cannabis Use ◽  
Urine Test ◽  
Icd 10 ◽  
Design And Methods ◽  
Cannabis Hyperemesis Syndrome

<b>Objective</b> <p>To differentiate diabetic ketoacidosis (DKA) from hyperglycemic ketosis due to cannabis hyperemesis syndrome (HK-CHS) in adults with type 1 diabetes.</p> <p><b>Research Design and Methods</b></p> <p>Of 295 adults with type 1 diabetes who were seen with DKA related ICD-10 codes, 68 patients with 172 DKA events meeting the inclusion criteria were analyzed. Cannabis use was defined as positive urine test for cannabis. Linear mixed models were used to define HK-CHS (pH ≥7.4 with bicarbonate ≥ 15) and sensitivity and specificity were calculated using receiver operating characteristic (ROC).</p> <p><b>Results</b></p> <p>Cannabis users had significantly higher pH (7.42 ± 0.01 vs 7.09 ± 0.02) and bicarbonate (19.2 ± 0.61 vs 9.1 ± 0.71) (p<0.0001) compared to non-users. The area under the ROC for positive cannabis urine test predicting HK-CHS was 0.9892.</p> <p><b>Conclusions</b></p> <p>In patients who present with DKA and higher pH, especially pH ≥ 7.4, cannabis use should be considered in differential diagnosis.</p>

Cardiac troponin I concentrations in people presenting with diabetic ketoacidosis

2007 ◽  
Vol 44 (4) ◽  
pp. 391-393 ◽  
Author(s):  
J Geddes ◽  
K A Deans ◽  
A Cormack ◽  
D Motherwell ◽  
K Paterson ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Cardiac Troponin ◽  
Large Scale ◽  
Troponin I ◽  
Wide Spectrum ◽  
Cardiac Troponin I ◽  
Medical Disorders ◽  
Beta Hydroxybutyrate

Background: Elevated troponin concentrations may be observed in a wide spectrum of medical disorders in people without evidence of overt ischaemic heart disease. The prospective relationship between serum cardiac troponin I (cTnI) and diabetic ketoacidosis (DKA) has not been examined in adults. Methods: Forty patients (14 male and 26 female) with type 1 diabetes were recruited. cTnI, creatine kinase (CK), cystatin C and beta-hydroxybutyrate were measured on admission and at 24, 48 and 72 h post-admission. Daily electrocardiographs were also performed. Results: Four out of forty subjects presenting with DKA had an increase in cTnI (median (SD) 0.06 (0.31) μg/L). One of the subjects had multiple possible reasons for the elevated cTnI concentration. However, the other three subjects had no obvious precipitating factors. This cohort underwent echocardiography and thallium-201 scintigraphy, which revealed no abnormalities. Conclusions: Minor troponin elevations appear to occur in a small number of subjects with type 1 diabetes presenting with DKA. The clinical relevance of this at this stage remains unknown and further large-scale studies are suggested.

scholarly journals Differences in physiological responses to cardio-pulmonary exercise testing in adults with type 1 diabetes and controls without type 1 diabetes – a pooled analysis

2020 ◽  
Author(s):  
Max L. Eckstein ◽  
Juliano Boufleur Farinha ◽  
Olivia McCarthy ◽  
Daniel J. West ◽  
Jane E. Yardley ◽  
...  
Keyword(s):  
Heart Rate ◽  
Type 1 Diabetes ◽  
Oxygen Uptake ◽  
Physiological Responses ◽  
Peak Oxygen Uptake ◽  
Pooled Analysis ◽  
Cycle Ergometer ◽  
Recent Onset ◽  
Design And Methods

<b>OBJECTIVE</b> <p>To investigate physiological responses to cardio-pulmonary exercise (CPX) testing in adults with type 1 diabetes compared to age-, sex- and body mass index- (BMI) matched controls without type 1 diabetes.</p> <p><b>RESEARCH DESIGN AND METHODS</b></p> <p>We compared results from CPX tests on a cycle ergometer in individuals with type 1 diabetes and controls without type 1 diabetes. Parameters were peak and threshold variables of oxygen uptake, heart rate and power output. Differences between groups were investigated via restricted maximum likelihood modelling and post-hoc tests. Differences between groups were explained by stepwise linear regressions (p<0.05). </p> <p><b>RESULTS</b></p> <p>Among 303 individuals with type 1 diabetes (age 33 [22; 43] years, 93 females, BMI 23.6 [22; 26] kg/m<sup>2</sup>, HbA<sub>1c</sub> 6.9 [6.2; 7.7]%; 52 [44; 61] mmol/mol), peak oxygen uptake (32.55 [26.49; 38.72] vs. 42.67 ± 10.44) (mL/kg/min), peak heart rate (179 [170; 187] vs. 184 [175; 191]) (bpm) and peak power (216 [171; 253] vs. 245 [200; 300]) (Watt) were lower in comparison to 308 controls without type 1 diabetes (all p<0.001). Individuals with type 1 diabetes displayed an impaired degree and direction of the heart rate to performance curve compared against controls without type 1 diabetes (0.07 [-0.75; 1.09] vs. 0.66 [-0.28; 1.45] (p<0.001)). None of the exercise physiological responses were associated with HbA<sub>1c</sub> in individuals with type 1 diabetes.</p> <p><b>CONCLUSIONS</b></p> <p>Individuals with type 1 diabetes show altered responses to CPX testing, which cannot be explained by HbA<sub>1c</sub>. Intriguingly, the participants in our cohort consisted of people with recent-onset type 1 diabetes, heart rate dynamics were altered during CPX testing. </p>

Sign in / Sign up

Export Citation Format

Share Document