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Mitigation of hypoglycemia during Ramadan using the flash glucose monitoring system following dose adjustment of insulin and sulphonylurea in patients taking multiple glucose-lowering therapies (The PROFAST-IT Study).
Elhadd, T, Bashir, M, Baager, KA, Ali, HA, Almohannadi, DHS, Dabbous, Z, Malik, RA, Abou-Samra, AB, ,
Diabetes research and clinical practice. 2021;:108589
Abstract
BACKGROUND AND HYPOTHESIS Patients with type-2 diabetes mellitus (T2DM) on multiple glucose-lowering therapies who fast during Ramadan are at increased risk of hypoglycemia. We have assessed the utility of the flash glucose monitoring system after adjusting the dose of insulin and sulphonylureas to mitigate the risk of hypoglycemia in patients with T2DM who fast during Ramadan. PATIENTS AND METHODS Patients with T2DM on either basal insulin or a sulphonylurea and at least 2 other glucose-lowering agents received structured education and adjustment of insulin or sulphonylurea dose according to the PROFAST Ramadan protocol. Glucose variability and episodes of hypoglycemia were assessed using the flash glucose monitoring system (Free Style Libre) before and during Ramadan. RESULTS A total of 33 patients with T2DM (on sulphonylurea (SU+) (n = 21), on basal insulin (BI+) (n = 12) aged 50.8 ± 1.6 years with a diabetes duration of 13.1 ± 6.5 years were studied. The average sensor glucose was 154 ± 34 mg/dl (8.5 ± 1.88 mmol/l) with 65.2% in the target range before Ramadan and the average sensor glucose was 156 ± 36 mg/dl (8.6 ± 2.0 mmol/l) with 67.1% in the target range during Ramadan. The incidence of hypoglycemia in the whole group (2.9 v 2.9) and in the SU+ (3.7 vs 3.0) and BI+ (1.7 vs 2.9) groups and eHbA1c (P = 0.56, P = 0.93), average glucose (P = 0.56, P = 0.92) and time within range (P = 0.63, P = 0.73) did not change in the SU+ and BI+ groups, respectively, before and during Ramadan. CONCLUSION Structured education with adjustment of the dose of glucose lowering medication alongside use of the FGMS can effectively mitigate the increased risk of hypoglycemia in patients with T2DM on multiple glucose-lowering therapies who fast during Ramadan.
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Management of glucose profile throughout strict COVID-19 lockdown by patients with type 1 diabetes prone to hypoglycaemia using sensor-augmented pump.
Viñals, C, Mesa, A, Roca, D, Vidal, M, Pueyo, I, Conget, I, Giménez, M
Acta diabetologica. 2021;(3):383-388
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AIMS: Spain has been one of the worst affected countries by the COVID-19 pandemic. A very strict lockdown at home was imposed with a tough restriction of mobility. We aimed to evaluate the impact of this exceptional scenario on glucose profile of patients with type 1 diabetes (T1D) prone to hypoglycaemia using sensor-augmented pump (SAP). METHODS Patients with T1D prone to hypoglycaemia using SAP (640G Medtronic-Minimed®) for at least 6 months under the funding of a National Health Service were included in an observational, retrospective study. Data were collected in two periods: pre-lockdown (PL), February 23rd-March 7th and within lockdown (WL), April 1st to 14th 2020. The primary outcome was the difference in the proportion of time in target glucose range of 70-180 mg/dL (TIR). Additional glucometric data and total daily insulin were also analysed. RESULTS Fifty-nine patients were included: 33 women, age 46.17 ± 13.0 years and disease duration of 30.2 ± 12.0 years. TIR 70-180 mg/dL (67.6 ± 11.8 vs. 69.8 ± 12.0%), time > 180 (28.1 ± 13.6 vs. 25.5 ± 13.1%), time > 250 (6.9 ± 6.1 vs. 5.1 ± 4.8) and estimated HbA1c (6.94 ± 0.8 vs. 6.75 ± 0.7%) significantly improved (PL vs. WL, respectively, p < 0.05). Time in hypoglycaemia, coefficient of variation, sensor usage and total daily insulin dose remained unchanged. CONCLUSIONS Lockdown conditions imposed by the COVID-19 pandemic may be managed successfully in terms of glycaemia control by population with DT1 prone to hypoglycaemia using SAP. The strict daily routine at home could probably explain the improvement in the time in glycemic target without increasing the time hypoglycaemia.
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Severe hypoglycaemia and absolute risk of cause-specific mortality in individuals with type 2 diabetes: a UK primary care observational study.
Zaccardi, F, Ling, S, Lawson, C, Davies, MJ, Khunti, K
Diabetologia. 2020;(10):2129-2139
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AIMS/HYPOTHESIS Several pathophysiological mechanisms would suggest a causal link between hypoglycaemia and cardiovascular death; conversely, current knowledge would not support a causal relationship with other causes of death. To clarify the nature and the magnitude of the association between hypoglycaemia and death, we investigated the 5 year mortality risks for cardiovascular disease, cancer and other causes in individuals with type 2 diabetes admitted to hospital for a severe hypoglycaemic episode. METHODS We defined in the UK Clinical Practice Research Datalink database a prevalent cohort of adults with type 2 diabetes diagnosed between 1 January 1998 and 1 January 2011 (index date), with available linkage to the Office for National Statistics (ONS) and the Hospital Episode Statistics (HES). A hospital admission reporting hypoglycaemia as the underlying cause was identified before the index date in the HES; date and underlying cause of death were obtained from the ONS. We quantified the 5 year risk of cause-specific death in people with and without admission to hospital for severe hypoglycaemia, adjusting for potential confounders and accounting for competing risk. RESULTS Of the 74,610 subjects included in the cohort, 388 (0.5%) were admitted at least once for a severe hypoglycaemic episode; subjects admitted were older, with higher HbA1c and a greater prevalence of multimorbidity. During a median follow-up of 7.1 years, 236 (60.8%) and 18,539 (25.0%) deaths occurred in subjects with and without a previous severe hypoglycaemia, respectively. Non-cardiovascular causes accounted for 71% of all deaths in both subjects with and without hypoglycaemia. In a 60-year-old person with severe hypoglycaemia, the 5 year absolute risk of death, adjusted for age, sex, ethnicity, systolic blood pressure, total cholesterol, HbA1c, BMI, eGFR, smoking status, alcohol consumption and deprivation (Townsend score), was 6.6%, 1.1% and 13.1% for cardiovascular, cancer and other causes, respectively, while the 5 year absolute risk difference compared with a subject without severe hypoglycaemia was 4.7% (95% CI 1.0, 8.3) for cardiovascular, -1.4% (-4.1, 1.4) for cancer and 11.1% (6.1, 16.1) for other causes of death. Results were consistent in models further adjusted for medications and comorbidities (myocardial infarction, stroke, peripheral artery disease, heart failure, atrial fibrillation, cancer), with sulfonylurea and insulin associated with increased mortality rates (from cause-specific hazard ratio of 1.06 [95% CI 0.99, 1.14] for cancer death with use of sulfonylurea to 1.42 [1.29, 1.56] for cardiovascular death with use of insulin). Results were robust to missing data. CONCLUSIONS/INTERPRETATION The results of this study indicate severe hypoglycaemia as a marker of, rather than causally linked to, an increased risk of long-term mortality. Regardless of the nature of the association, a severe hypoglycaemic episode represents a strong negative prognostic factor in patients with type 2 diabetes. Graphical abstract.
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The impact of strict COVID-19 lockdown in Spain on glycemic profiles in patients with type 1 Diabetes prone to hypoglycemia using standalone continuous glucose monitoring.
Mesa, A, Viñals, C, Pueyo, I, Roca, D, Vidal, M, Giménez, M, Conget, I
Diabetes research and clinical practice. 2020;:108354
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AIMS: Spain has been one of the worst affected countries by the COVID-19 pandemic. A very strict lockdown at home was imposed with a tough restriction of mobility. We aimed to evaluate the impact of this exceptional scenario on glucose profile of patients with T1D prone to hypoglycemia using standalone continuous glucose monitoring. METHODS Patients with T1D prone to hypoglycemia using multiple daily injections and either a Dexcom G5® or a Free Style Libre® CGM systems for at least 6 months under the funding of National Health Service were included in an observational, retrospective study. Data were collected in two periods: pre-lockdown (PL), February 23rd-March 7th and within lockdown (WL), April 1st-14th 2020. The primary outcome was the difference in the proportion of time in target glucose range of 70-180 mg/dL (TIR). Additional glucometric data were also analysed. RESULTS 92 patients were included: 40 women, age 42.8 ± 3.9 years, disease duration of 23.1 ± 12.6 years. Seventeen patients used Dexcom G5® and 75 Free Style Libre®. TIR 70-180 mg/dL (59.3 ± 16.2 vs 62.6 ± 15.2%), time > 180 (34.4 ± 18.0 vs 30.7 ± 16.9%), >250 (11.1 ± 10.6 vs 9.2 ± 9.7%) and Glucose Management Indicator (7.2 ± 0.8 vs 7.0 ± 0.8%) significantly improved (PL vs WL, respectively, p < 0.05). Time in hypoglycemia remained unchanged. CONCLUSIONS Lockdown conditions imposed by the COVID-19 pandemic may be managed successfully in terms of glycemic control by population with T1D prone to hypoglycemia using CGM. The strict daily routine at home could probably explain the improvement in the time in glycemic target without increasing the time in hypoglycemia.
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Glycemic profile assessment during betamethasone administration in women with gestational diabetes mellitus.
Kakoulidis, I, Ilias, I, Linardi, A, Milionis, C, Michou, A, Koukkou, E
Diabetes & metabolic syndrome. 2019;(1):214-215
Abstract
AIM: Betamethasone's effect on glucose homeostasis in the presence of gestational diabetes has not been adequately investigated. MATERIALS-METHODS We assessed the glycemic profile of 99 women with gestational diabetes (52 on insulin, 47 on medical nutrition therapy) who were given betamethasone during hospitalization for at risk pregnancies. RESULTS In insulin-treated women the increase in total daily insulin dose significantly linked to betamethasone dose (p = 0.014). In women on diet, the need for insulin was positively related to betamethasone dose, age and gestational age >34th week (all p < 0.05). CONCLUSION Parsimonious betamethasone use might still be beneficial with a milder effect on glycemia.
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Assessment of the effectiveness of long-term insulin pump therapy using a combined goal of HbA1c decrease and absence of severe hypoglycemia.
Quirós, C, Viñals, C, Giménez, M, Roca, D, Conget, I
Endocrinologia, diabetes y nutricion. 2019;(9):534-539
Abstract
OBJECTIVE Less than one third of patients with type 1 diabetes mellitus (T1DM) achieve the cut-off value proposed as good metabolic control by most guidelines, HbA1c<7%. However, HbA1c reductions and prevention of severe hypoglycemia (SH) have shown clinically relevant benefits. The study objective therefore was to assess the effectiveness of continuous subcutaneous insulin infusion (CSII) therapy at 5 years of follow-up in a cohort of patients attending a specialized unit using HbA1c reduction and abscence of SH as combined goals. METHODS A retrospective, observational study on 178 patients with T1DM who started CSII treatment at Hospital Clinic of Barcelona between 2003 and 2008. HbA1c levels at baseline and after 5 years of treatment with CSII and presence or absence of SH were recorded. The combined variables calculated included: a) HbA1c reduction by≥0.5 points and absence of SH in the last 2 years; b) HbA1c at 5 years<7.5% and no SH in the last 2 years; c) HbA1c<8.5% and no HG in the last 2 years, and d) HbA1c reduction by≥0.5 points and/or HbA1c<7.5% at 5 years with no SH in the last 2 years of follow-up. RESULTS Twenty-seven of the 178 patients were excluded due to loss to follow-up or CSII discontinuation. A total of 151 patients (aged 37.4±10.5 years, 64% women, diabetes duration of 19.2±10.7 years) were therefore analyzed. The 2 main reasons for starting CSII were suboptimal metabolic control (60.9%) and severe hypoglycemia/hypoglycemia unawareness (28.5%). HbA1c levels in the total cohort and in patients with suboptimal metabolic control were 8.0±1.2 and 8.4±1.1% at CSII start and 7.8±1.2 and 8.0±1.3% at 5 years of treatment (P=.104 and P=.016) respectively. In the overall cohort, 55.5% of patients achieved at 5 years the combined goal of HbA1c<7.5% and/or HbA1c reductions≥0.5% without SH. CONCLUSIONS After 5 years of CSII therapy, more than half of the patients achieved the combined goal of significant HbA1c reduction and absence of SH. The use of combined goals offers the opportunity to assess the effectiveness of T1DM treatment from a clinically more meaningful point of view.
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Impact of Insulin Degludec in Hospitalized Patients With and Without Type 2 Diabetes Requiring Parenteral/Enteral Nutrition: An Observational Study.
Fatati, G, Di Donato, A, Grandone, I, Menicocci, P, Mirri, E, Prosperini, G, Scardapane, M, Rossi, MC, Palazzi, M
Advances in therapy. 2018;(6):809-816
Abstract
INTRODUCTION Hyperglycemia in inpatients is a major problem, especially when nutritional support is required. This study aims to assess the impact of treatment with insulin degludec (IDeg) on mean blood glucose (BG) and glycemic variability in noncritical hospitalized patients with and without type 2 diabetes (T2DM) receiving enteral and/or parenteral nutrition (EN, PN). METHODS Mean BG and glycemic variability from admission up to 7 days of hospitalization were evaluated in consecutive cases with and without T2DM. Percentage of coefficient of variation (CV) for glucose was used to express glycemic variability. RESULTS Overall, 26 patients (13 with and 13 without T2DM) were admitted to the hospital for any cause. Subjects were 65.4% men and they were mainly elderly (mean age 66.3 ± 13.4 years). PN was administered in 88.5% of patients and EN in 19.2%. At admission, mean HbA1c level was 5.9 ± 0.7% in patients without diabetes and 9.1 ± 2.5% in patients with T2DM. During hospitalization, mean daily BG levels changed from 151 ± 47.3 mg/dl (day 1) to 157 ± 66.7 mg/dl (day 7) in patients without diabetes and from 210 ± 66.5 mg/dl to 192 ± 48.6 mg/dl in patients with T2DM. CV decreased from 14% (day 1) to 11% (day 7) in patients without diabetes and from 20% (day 1) to 9% (day 7) in patients with T2DM. No symptomatic or severe hypoglycemia occurred. CONCLUSIONS Despite the small sample size and the lack of control group, this study represents the first proof-of-concept that IDeg in hospitalized patients with or without T2DM who require nutritional support has the potential to maintain stable levels of BG and reduce glycemic variability. FUNDING Novo Nordisk S.p.A. grant.
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Clinical characteristics of type 2 diabetes patients with discordance between HbA1c and fasting plasma glucose in the real world: An analysis of the ORBIT study.
Shu, H, Lu, J, Zhang, P, Zhu, D, Li, X, Ji, J, Zhao, F, Ji, L
Diabetes/metabolism research and reviews. 2018;(4):e2977
Abstract
BACKGROUND We aimed to determine the clinical characteristics of type 2 diabetes patients on basal insulin therapy with inadequate glucose control due to discordance between glycated haemoglobin (HbA1c ) and fasting plasma glucose (FPG) in the real world. METHODS This was a retrospective analysis of data from the ORBIT study in China. Clinical characteristics of patients with discordance between HbA1c and FPG at baseline and at the end of 6 months of follow-up were analysed using multinomial logistic regression in 4 study groups divided by HbA1c and FPG. RESULTS Overall, of 6721 patients initiated on basal insulin, 853 achieved HbA1c < 7% but FPG ≥ 7 mmol/L (group 2), while 997 had FPG < 7 mmol/L but HbA1c ≥ 7% (group 3) at the end of follow-up. Patients in group 3 had a longer duration of type 2 diabetes compared with those in group 2 (7.22 ± 5.30 vs 6.00 ± 4.80 y, P < .05). Patients on glargine (32.90%) or detemir (36.88%) treatment accounted for a higher proportion of patients with both HbA1c and FPG controlled than those on neutral protamine Hagedorn therapy (23.45%; P < .05). Per the multinomial logistic analysis, higher frequency of self-monitoring of blood glucose (SMBG) and use of glargine or detemir therapy were significantly inversely associated with risk of discordance between HbA1c and FPG, while dose of insulin was a risk factor for discordance at the end of follow-up (all P < .05). CONCLUSIONS Patients treated with insulin analogues (glargine or detemir), instead of neutral protamine Hagedorn, and with more frequent SMBG are more likely to exhibit concordance between HbA1c and FPG.
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HbA1c response after insulin initiation in patients with type 2 diabetes mellitus in real life practice: Identifying distinct subgroups.
Sidorenkov, G, van Boven, JFM, Hoekstra, T, Nijpels, G, Hoogenberg, K, Denig, P
Diabetes, obesity & metabolism. 2018;(8):1957-1964
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AIMS: To identify subgroups of patients with type 2 diabetes mellitus (T2DM) following distinct trajectories of HbA1c after insulin initiation and explore underlying differences in clinical characteristics. MATERIALS AND METHODS A cohort study was conducted in patients with T2DM initiating insulin in 2007-2013 with a follow-up of 2 to 4 years. Data were collected from the Groningen Initiative to Analyze Type 2 Diabetes Treatment (GIANTT) database. The primary outcome was subgroups with different trajectories of HbA1c patterns after insulin initiation, as identified by latent class growth modeling. Differences between subgroups were tested using one-way ANOVA, Kruskal-Wallis or chi-square tests, where appropriate. RESULTS From 1459 patients, three subgroups with distinct HbA1c patterns were identified. Group 1 (8%) initially showed a moderate decrease followed by an increase in HbA1c 2 years later, despite receiving more comedication. Group 2 (84%) showed a stable decrease. Group 3 (8%) had a high initial level of HbA1c and a rapid decline within the first year, followed by a slow increase thereafter. Group 1 patients were on average 6-7 years younger than patients in groups 2 and 3 and were more likely to receive sulfonylureas than Group 3 patients. Group 3 patients had a shorter diabetes duration and were less well-controlled for HbA1c, systolic blood pressure and LDL-cholesterol at insulin initiation. CONCLUSIONS Most patients showed a stable HbA1c response, but one out of six patients showed either a poor response, or a rapid initial response only after insulin initiation. Response patterns were associated with age, diabetes duration and risk-factor controls at the time of insulin initiation.
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Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study.
Charleer, S, Mathieu, C, Nobels, F, De Block, C, Radermecker, RP, Hermans, MP, Taes, Y, Vercammen, C, T'Sjoen, G, Crenier, L, et al
The Journal of clinical endocrinology and metabolism. 2018;(3):1224-1232
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CONTEXT Randomized controlled trials evaluating real-time continuous glucose monitoring (RT-CGM) patients with type 1 diabetes (T1D) show improved glycemic control, but limited data are available on real-world use. OBJECTIVE To assess impact of RT-CGM in real-world settings on glycemic control, hospital admissions, work absenteeism, and quality of life (QOL). DESIGN Prospective, observational, multicenter, cohort study. PARTICIPANTS A total of 515 adults with T1D on continuous subcutaneous insulin infusion (CSII) therapy starting in the Belgian RT-CGM reimbursement program. INTERVENTION Initiation of RT-CGM reimbursement. MAIN OUTCOME MEASURE Hemoglobin A1c (HbA1c) evolution from baseline to 12 months. RESULTS Between September 1, 2014, and December 31, 2016, 515 adults entered the reimbursement system. Over this period, 417 (81%) patients used RT-CGM for at least 12 months. Baseline HbA1c was 7.7 ± 0.9% (61 ± 9.8 mmol/mol) and decreased to 7.4 ± 0.8% (57 ± 8.7 mmol/mol) at 12 months (P < 0.0001). Subjects who started RT-CGM because of insufficient glycemic control showed stronger decrease in HbA1c at 4, 8, and 12 months compared with patients who started because of hypoglycemia or pregnancy. In the year preceding reimbursement, 16% of patients were hospitalized for severe hypoglycemia or ketoacidosis in contrast to 4% (P < 0.0005) the following year, with decrease in admission days from 54 to 18 per 100 patient years (P < 0.0005). In the same period, work absenteeism decreased and QOL improved significantly, with strong decline in fear of hypoglycemia. CONCLUSION Sensor-augmented pump therapy in patients with T1D followed in specialized centers improves HbA1c, fear of hypoglycemia, and QOL, whereas work absenteeism and admissions for acute diabetes complications decreased.