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result(s) for
"Dungan, Kathleen"
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Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial
by
Forst, Thomas
,
Povedano, Santiago Tofé
,
Atisso, Charles
in
Analysis of Variance
,
Biological and medical sciences
,
Blood Glucose - metabolism
2014
Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes.
We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m2 or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide (1·8 mg). Randomisation was done according to a computer-generated random sequence with an interactive voice response system. Participants and investigators were not masked to treatment allocation. The primary outcome was non-inferiority (margin 0·4%) of dulaglutide compared with liraglutide for change in HbA1c (least-squares mean change from baseline) at 26 weeks. Safety data were collected for a further 4 weeks' follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01624259.
We randomly assigned 599 patients to receive once-weekly dulaglutide (299 patients) or once-daily liraglutide (300 patients). 269 participants in each group completed treatment at week 26. Least-squares mean reduction in HbA1c was −1·42% (SE 0·05) in the dulaglutide group and −1·36% (0·05) in the liraglutide group. Mean treatment difference in HbA1c was −0·06% (95% CI −0·19 to 0·07, pnon-inferiority<0·0001) between the two groups. The most common gastrointestinal adverse events were nausea (61 [20%] in dulaglutide group vs 54 [18%] in liraglutide group), diarrhoea (36 [12%] vs 36 [12%]), dyspepsia (24 [8%] vs 18 [6%]), and vomiting (21 [7%] vs 25 [8%]), with similar rates of study or study drug discontinuation because of adverse events between the two groups (18 [6%] in each group). The hypoglycaemia rate was 0·34 (SE 1·44) and 0·52 (3·01) events per patient per year, respectively, and no severe hypoglycaemia was reported.
Once-weekly dulaglutide is non-inferior to once-daily liraglutide for least-squares mean reduction in HbA1c, with a similar safety and tolerability profile.
Eli Lilly and Company.
Journal Article
Stress hyperglycaemia
by
Dungan, Kathleen M
,
Braithwaite, Susan S
,
Preiser, Jean-Charles
in
Acute Disease
,
Biological and medical sciences
,
Blood Glucose - metabolism
2009
Results of randomised controlled trials of tight glycaemic control in hospital inpatients might vary with population and disease state. Individualised therapy for different hospital inpatient populations and identification of patients at risk of hyperglycaemia might be needed. One risk factor that has received much attention is the presence of pre-existing diabetes. So-called stress hyperglycaemia is usually defined as hyperglycaemia resolving spontaneously after dissipation of acute illness. The term generally refers to patients without known diabetes, although patients with diabetes might also develop stress hyperglycaemia—a fact overlooked in many studies comparing hospital inpatients with or without diabetes. Investigators of several studies have suggested that patients with stress hyperglycaemia are at higher risk of adverse consequences than are those with pre-existing diabetes. We describe classification of stress hyperglycaemia, mechanisms of harm, and management strategies.
Journal Article
Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study
by
May, Casey C
,
Jones, Laureen
,
Smetana, Keaton S
in
Analysis
,
Blood sugar
,
Blood sugar monitoring
2021
Abstract
Context
The coronavirus disease 2019 (COVID-19) pandemic has created a need for remote blood glucose (BG) monitoring in the intensive care unit (ICU).
Objective
To evaluate feasibility and patient safety of a hybrid monitoring strategy of point-of-care (POC) BG plus continuous glucose monitor (CGM) in the ICU.
Design
Retrospective analysis.
Setting
ICU of an academic medical center.
Patients
Patients with COVID-19 on IV insulin.
Intervention
After meeting initial validation criteria, CGM was used for IV insulin titration and POC BG was performed every 6 hours or as needed.
Main Outcome Measures
Outcomes included frequency of POC BG, workflow, safety, and accuracy measures.
Results
The study included 19 patients, 18 with CGM data, mean age 58 years, 89% on mechanical ventilation, 37% on vasopressors, and 42% on dialysis. The median time to CGM validation was 137 minutes (interquartile range [IQR] 114-206). During IV insulin, the median number of POC values was 7 (IQR 6-16) on day 1, and declined slightly thereafter (71% reduction compared with standard of 24/day). The median number of CGM values used nonadjunctively to titrate IV insulin was 11.5 (IQR 0, 15) on day 1 and increased thereafter. Time in range 70 to 180 mg/dL was 64 ± 23% on day 1 and 72 ± 16% on days 2 through 7, whereas time <70 mg/dL was 1.5 ± 4.1% on day 1 and <1% on days 2 through 7.
Conclusions
This study provides data to support that CGM using a hybrid protocol is feasible, accurate, safe, and has potential to reduce nursing and staff workload.
Journal Article
Implementation of Continuous Glucose Monitoring in Critical Care: A Scoping Review
2023
Purpose of ReviewThe aim of this review is to identify the implementation approaches, strategies, and outcomes for continuous glucose monitoring (CGM) in the intensive care unit (ICU). Medline and Web of Science databases were searched to report relevant literature published between September 12, 2016 and September 12, 2021. Implementation outcomes and strategies, defined by the Expert Recommendations for Implementing Change (ERIC) project, were extracted.Recent FindingsOf the 324 titles reviewed, 16 articles were included in the review. While no studies were identified as implementation research, 14 of 16 identified implementation strategies that aligned with ERIC definitions. Included studies described a multi-disciplinary approach. Clinical outcomes included Mean Absolute Relative Difference (MARD), ranging from 7.5 to 15.3%, and 33–71% reduction in frequency of point-of-care (POC) blood glucose monitoring (BGM) using hybrid protocols.SummaryThis scoping review provides valuable insight into the process of CGM implementation in the ICU. Continued research should include implementation outcomes to inform widespread utilization.
Journal Article
1,5-anhydroglucitol (GlycoMark™) as a marker of short-term glycemic control and glycemic excursions
1,5-anhydroglucitol (1,5-AG) is a validated marker of short-term glycemic control. It is a metabolically inert polyol that competes with glucose for reabsorption in the kidneys. Otherwise stable levels of 1,5-AG are rapidly depleted as blood glucose levels exceed the renal threshold for glucosuria. 1,5-AG more accurately predicts rapid changes in glycemia than hemoglobin A1C (A1C) or fructosamine. It is also more tightly associated with glucose fluctuations and postprandial glucose. Thus, 1,5-AG may offer complementary information to A1C. This review will summarize the limitations of current methods of assessing glycemic control, assess the data to support 1,5-AG as a glycemic marker and highlight the scenarios by which 1,5-AG may fill the gap in assessing glycemic control.
Journal Article
Effect of beta blocker use and type on hypoglycemia risk among hospitalized insulin requiring patients
by
Dungan, Kathleen
,
Long, Clarine
,
Merrill, Jennifer
in
Adrenergic beta-Antagonists - administration & dosage
,
Adrenergic beta-Antagonists - adverse effects
,
Aged
2019
Background
Although beta blockers could increase the risk of hypoglycemia, the difference between subtypes on hypoglycemia and mortality have not been studied. This study sought to determine the relationship between type of beta blocker and incidence of hypoglycemia and mortality in hospitalized patients.
Methods
We retrospectively identified non-critically ill hospitalized insulin requiring patients who were undergoing bedside glucose monitoring and received either carvedilol or a selective beta blocker (metoprolol or atenolol). Patients receiving other beta blockers were excluded. Hypoglycemia was defined as any glucose < 3.9 mmol/L within 24 h of admission (Hypo
1day
) or throughout hospitalization (Hypo
T
) and any glucose < 2.2 mmol/L throughout hospitalization (Hypo
severe
).
Results
There were 1020 patients on carvedilol, 886 on selective beta blockers, and 10,216 on no beta blocker at admission. After controlling for other variables, the odds of Hypo
1day,
Hypo
T
and Hypo
severe
were higher for carvedilol and selective beta blocker recipients than non-recipients, but only in basal insulin nonusers. The odds of Hypo
1day
(odds ratio [OR] 1.99, 95% confidence interval [CI] 1.28, 3.09, p = 0.0002) and Hypo
T
(OR 1.38, 95% CI 1.02, 1.86, p = 0.03) but not Hypo
severe
(OR 1.90, 95% CI 0.90, 4.02, p = 0.09) were greater for selective beta blocker vs. carvedilol recipients in basal insulin nonusers. Hypo
1day
, Hypo
T
, and Hypo
severe
were all associated with increased mortality in adjusted models among non-beta blocker and selective beta blocker recipients, but not among carvedilol recipients.
Conclusions
Beta blocker use is associated with increased odds of hypoglycemia among hospitalized patients not requiring basal insulin, and odds are greater for selective beta blockers than for carvedilol. The odds of hypoglycemia-associated mortality are increased with selective beta blocker use or nonusers but not in carvedilol users, warranting further study.
Journal Article
Real-World Implications of Hybrid Close Loop (Hcl) Insulin Delivery System
by
Dungan, Kathleenbn M.
,
Zappe, Janet
,
Faulds, Eileen R.
in
Blood Glucose
,
Clinical trials
,
Diabetes Mellitus, Type 1
2019
Clinical trial data demonstrates improved glycemic control with hybrid close loop (HCL) insulin delivery systems, yet limited real-world data exists. Data from the inaugural cohort of patients initiating a HCL system (Medtronic MiniMed
670G, Medtronic Canada, Brampton, ON) at a university medical center was used to examine real-world utilization and glycemic control following a standardized implementation process.
Data from 34 adult patients with type 1 diabetes were obtained from pump downloads at 4 time points: (
) previous insulin pump, (
) HCL in manual-mode, (
) 2 weeks after HCL auto-mode transition, and (
) 6 to 12 weeks after initiation of HCL. In-person training by certified diabetes educators was performed across 3 sessions with phone and electronic messaging following auto-mode start.
Mean self-monitored blood glucose (SMBG) per day increased from 5.15 baseline to 6.49 at 6 to 12 weeks (
<.05) with 3.26 sensor calibrations per day. Time-in-auto-mode was 79.3% at 2 weeks and 72.3% at final follow-up, with 82% of patients spending >50% of time in auto-mode. There were 8.2 auto-mode exits over the final 14-day download. Time-in-target was 67.3% in manual-mode, 73.4% at 2 weeks (
= .09), and 71.7% by 6 to 12 weeks (
= .06). Hemoglobin A1c (HbA1c) decreased by 0.51% (
= .02), while total daily dose and % basal did not change. Patients with HbA1c <7.0% (53 mmol/mol) at baseline spent more time-in-target than those with HbA1c ≥7.0% (53 mmol/mol; 78.0% versus 67.5%) despite spending less time-in-auto-mode (66.5% versus 74.8%).
These data illustrate real-world implementation of HCL technology using a structured education program within a major medical center. Overall benefit may vary based on baseline characteristics such as HbA1c.
= certified diabetes educator;
= hemoglobin A1c;
= hybrid closed loop;
= self-monitored blood glucose.
Journal Article
Prevalence, predictors, and outcomes of steroid-induced hyperglycemia in hospitalized patients with hematologic malignancies
by
Alwan, Dhuha
,
Healy, Sara J
,
Nagaraja, Haikady N
in
Bone marrow
,
Bone marrow transplantation
,
Chemotherapy
2017
PurposeTo determine prevalence, predictors, and outcomes of steroid-induced hyperglycemia in hospitalized patients with hematologic malignanciesMethodsWe performed retrospective analysis of patients who were hospitalized on any of the four hematology services or bone marrow transplant service and who received systemic steroids during a 2-month period. Mean glucoses for days 1–4 and maximum glucose were calculated and the total daily steroid dose was converted to equivalent dose of dexamethasone. Hyperglycemia was defined as any glucose >9.917 mmol/l during days 1–4. We examined associations between variables using Spearman's correlations and multivariable linear regressionResults168 patients were included in the analysis. Mean age was 57.1 ± 14.4 years with 59% males and 90% Caucasians. The prevalence of hyperglycemia was 39%. Eight patients received intravenous insulin. In patients without diabetes, steroid dose equivalent to >12 mg dexamethasone and longer acting steroids caused greater degree of hyperglycemia compared to a dose <12 mg. Maximum glucose was a predictor of hospital length of stay among patients without diabetes (but not those with diabetes), and with acute leukemia or stem cell transplant (but not other hematologic malignancies). There were no significant differences in in mortality or other outcomes between the groups with and without hyperglycemiaConclusionsHyperglycemia is common in patients with hematologic malignancies, which require frequent corticosteroids. Higher steroid dose and long-acting steroids caused a greater degree of hyperglycemia. Maximum glucose was a predictor of length of stay but this was only significant for patients without diabetes, those with acute hematologic malignancy or stem cell transplant.
Journal Article
Risk of pancreatic cancer associated with GLP-1 receptor agonist therapy
2026
The use of glucagon-like peptide-1 receptor agonists (GLP-1RAs) is increasingly common due to dramatic improvement in clinical outcomes of metabolic conditions. In this narrative review we introduce the preclinical data related to this receptor pathway and pancreatic ductal adenocarcinoma. Then, we summarize clinical data from postmarketting surveillance, randomized controlled trials, and observational studies. Lastly, we present considerations to accurately interpret these data and outline key knowledge gaps for further investigation.
Journal Article
A Medicaid-Funded Statewide Diabetes Quality Improvement Collaborative: Ohio 2020‒2022
by
Konstan, Michael W.
,
Adams, Kelly McCutcheon
,
Uddin, Shah Jalal
in
Care plans
,
Clinical outcomes
,
Collaboration
2023
We used a collective impact model to form a statewide diabetes quality improvement collaborative to improve diabetes outcomes and advance diabetes health equity. Between 2020 and 2022, in collaboration with the Ohio Department of Medicaid, Medicaid Managed Care Plans, and Ohio’s seven medical schools, we recruited 20 primary care practices across the state. The percentage of patients with hemoglobin A1c greater than 9% improved from 25% to 20% over two years. Applying our model more broadly could accelerate improvement in diabetes outcomes. (Am J Public Health. 2023;113(12):1254–1257. https://doi.org/10.2105/AJPH.2023.307410 )
Journal Article