Dataset Information

HbA1c and hypoglycaemia in intensively treated type 2 diabetes: a retrospective cohort study in primary care.

ABSTRACT:

Objective

To establish whether low HbA1c is associated with clinical hypoglycaemia among people with type 2 diabetes prescribed insulins or sulphonylureas.

Design

Retrospective cohort study using routine electronic GP health records collected between January 2013 and December 2015.

Setting

Three east London Clinical Commissioning Groups.

Participants

Two cohorts of adults with type 2 diabetes prescribed either (i) insulins with or without other oral antidiabetic medication (n = 6788, 36.4%) or (ii) sulphonylureas with or without other oral antidiabetic medications excluding insulins (n = 11,840, 63.6%).

Main outcome measures

First clinically recorded hypoglycaemia and all-cause mortality. Hazard ratios (HR) adjusting for age, ethnicity, renal function and comorbidities were calculated using Cox regression models.

Results

Compared with an HbA1c of 53-63 mmol/mol, the adjusted HR of hypoglycaemia in those with a low HbA1c, below 53 mmol/mol, in the insulin and sulphonylurea cohorts were 1.26 (95% CI, 0.97 to 1.62) and 1.54 (95% CI, 1.27 to 1.87), respectively. Adjusted HRs of all-cause mortality from low HbA1c in the insulin and sulphonylurea cohorts were 1.54 (95% CI, 1.15 to 2.07) and 1.42 (95% CI, 1.11 to 1.81), respectively. Increasing age and renal impairment were also associated with increased hypoglycaemic risk in both cohorts.

Conclusions

HbA1c below 53 mmol/mol was associated with episodes of clinical hypoglycaemia among people with type 2 diabetes prescribed sulphonylureas, and all-cause mortality in those prescribed insulins and sulphonylureas. These findings support the need for reviewing glycaemic targets and the intensities of treatment in those with low HbA1c prescribed insulins or sulphonylureas to reduce the risk of hypoglycaemia.

SUBMITTER: Malawana M

PROVIDER: S-EPMC6041855 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

HbA1c and hypoglycaemia in intensively treated type 2 diabetes: a retrospective cohort study in primary care.

Malawana Manil M Kerry Sally S Mathur Rohini R Robson John J

JRSM open 20180706 7

<h4>Objective</h4>To establish whether low HbA1c is associated with clinical hypoglycaemia among people with type 2 diabetes prescribed insulins or sulphonylureas.<h4>Design</h4>Retrospective cohort study using routine electronic GP health records collected between January 2013 and December 2015.<h4>Setting</h4>Three east London Clinical Commissioning Groups.<h4>Participants</h4>Two cohorts of adults with type 2 diabetes prescribed either (i) insulins with or without other oral antidiabetic medi ...[more]

PMID: 30013791

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Project description:PurposePeople with type 2 diabetes (T2D) have a doubled morbidity and mortality risk compared with persons with normal glucose tolerance. Despite treatment, clinical targets for cardiovascular risk factors are not achieved. The Hoorn Diabetes Care System cohort (DCS) is a prospective cohort representing a comprehensive dataset on the natural course of T2D, with repeated clinical measures and outcomes. In this paper, we describe the design of the DCS cohort.ParticipantsThe DCS consists of persons with T2D in primary care from the West-Friesland region of the Netherlands. Enrolment in the cohort started in 1998 and this prospective dynamic cohort currently holds 12 673 persons with T2D.Findings to dateClinical measures are collected annually, with a high internal validity due to the centrally organised standardised examinations. Microvascular complications are assessed by measuring kidney function, and screening feet and eyes. Information on cardiovascular disease is obtained by 1) self-report, 2) electrocardiography and 3) electronic patient records. In subgroups of the cohort, biobanking and additional measurements were performed to obtain information on, for example, lifestyle, depression and genomics. Finally, the DCS cohort is linked to national cancer and all-cause mortality registers. A selection of published findings from the DCS includes identification of subgroups with distinct development of haemoglobin A1c, blood pressure and retinopathy, and their predictors; validation of a prediction model for personalised retinopathy screening; the assessment of the role of genetics in development and treatment of T2D, providing options for personalised medicine.Future plansWe will continue with the inclusion of persons with newly diagnosed T2D, follow-up of persons in the cohort and linkage to morbidity and mortality registries. Currently, we are involved in (inter)national projects on, among others, biomarkers and prediction models for T2D and complications and we are interested in collaborations with external researchers.Trial registrationISRCTN26257579.

Project description:BackgroundClinical trials have demonstrated that initiating oral anti-diabetic drugs (OADs) significantly reduce glycated hemoglobin (HbA1c) levels. However, variability in lifestyle modifications and OAD adherence impact on their actual effect on glycemic control. Furthermore, evidence on dose adjustments and discontinuation of OAD on HbA1c is lacking. This study aims to use real-world data to determine the effect of OAD initiation, up-titration, down-titration, and discontinuation on HbA1c levels, among Asian patients managed in primary care.MethodsA retrospective cohort study over a 5-year period, from Jan 2015 to Dec 2019 was conducted on a cohort of multi-ethnic adult Asian patients with clinical diagnosis of type 2 diabetes mellitus (T2DM) managed by a network of primary care clinics in Singapore. Nine OADs from five different classes (biguanides, sulphonyurea, dipeptidyl peptidase-4 [DPP-4] inhibitors, sodium-glucose cotransporter-2 [SGLT-2] inhibitors, and alpha-glucosidase inhibitors) were evaluated. Patients were grouped into "No OAD", "Non-titrators," and "Titrators" cohorts based on prescribing patterns. For the "Titrators" cohort, the various OAD titrations were identified. Subsequently, a descriptive analysis of HbA1c values before and after each titration was performed to compute a mean difference for each unique titration identified.ResultsAmong the cohort of 57,910 patients, 43,338 of them had at least one OAD titration, with a total of 76,990 pairs of HbA1c values associated with an OAD titration. There were a total of 206 unique OAD titrations. Overall, initiation of OADs resulted in a reduction of HbA1c by 3 to 12 mmol/mol (0.3 to 1.1%), respectively. These results were slightly lower than those reported in clinical trials of 6 to 14 mmol/mol (0.5 to 1.25%). The change of HbA1c levels due to up-titration, down-titration, and discontinuation were -1 to -8 mmol/mol (-0.1 to -0.7%), +1 to 7 mmol/mol (+0.1 to +0.6%), and +2 to 11 mmol/mol (+0.2 to +1.0%), respectively. The HbA1c lowering effect of initiating newer OADs, namely DPP-4 inhibitors and SGLT-2 inhibitors was 8 to 11 mmol/mol (0.7 to 0.9%) and 7 to 11 mmol/mol (0.6 to 1.0%), respectively.ConclusionThe real-world data on Asians with T2DM in this study show that the magnitudes of OAD initiation and dose titration are marginally lower than the results from clinical trials. During shared decision-making in selecting treatment options, the results enable physicians to communicate realistic expectation of the effect of oral medications on the glycemic control of their patients in primary care.

Project description:BackgroundThe current study investigates the incidence, aetiology, and outcome of hypoglycaemia of patients without diabetes in the EMS.MethodsThe study was a retrospective cohort study that utilized electronic EMS patient record system (population of one million). All patients encountered by EMS with plasma glucose ≤3.9 mmol/l from 2009 to 2015 were included in the study and hospital records were screened manually to detect possible reasons for hypoglycaemia. Data from the governmental health insurance agency for all residents in Finland was used to reveal the diabetes status of the patients. Survival of the patients was followed from Population register centre up to six years. Serious hypoglycaemia was defined as plasma glucose ≤3.0 mmol/l.ResultsFrom EMS cases with a plasma glucose measurement a total of 5467 hypoglycaemic patients without diabetes were encountered by EMS during the study period with an incidence of 1082 (CI95% 1019-1148) per 100,000 inhabitants per year, corresponding 41.6%, (CI95% 40.8-42.3) of all hypoglycaemic patients. Of those patients, 3856 [71.6%, (CI95% 70.4-72.8)] were transported to hospital and 910 [23.2%, (CI95% 22.0-24.6)] had serious hypoglycaemia. The three main diagnosis groups that appeared in the subsequent hospital treatment associated with hypoglycaemia in all transported cases without diabetes as well with serious hypoglycaemia cases were: alcohol abuse [41.2%, (CI95% 39.7-42.8) and 42.2%, (CI95% 39.0-45.4)], hypothermia [17.2%, (CI95% 16.0-18.4) and 27.4%, (CI95% 24.6-30.4)], and malnutrition [16.9%, (CI95% 15.8-18.1) and 25.1%, (CI95% 22.4-28.0)]. Mortality ranged from 0.6-65.4% depending of admission reason and increased significantly at long-term. Non-Diabetics survival was less than with diabetics, when serious hypoglycaemia was present.DiscussionThe most common possible hypoglycaemia related aetiological causes encountered in the EMS, alcohol abuse, hypothermia, and malnutrition, although frequent are often relatively benign conditions. These possible causes of hypoglycaemia can often be treated at scene or need only short hospital admissions. Hence they are not so prevalent in hospital studies.ConclusionsHypoglycaemia without diabetes is commonly observed among the hypoglycaemic EMS cases. Main causes for it are alcohol abuse, hypothermia, and malnutrition. Mortality correlated with age, higher priority dispatch codes, and plasma glucose rate in multivariate logistic regression analysis. Some of the etiological subgroups carry a markedly high mortality rate.

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Project description:ObjectiveTo assess the risks of amputation, blindness, severe kidney failure, hyperglycaemia, and hypoglycaemia in patients with type 2 diabetes associated with prescribed diabetes drugs, particularly newer agents including gliptins or glitazones (thiazolidinediones).DesignOpen cohort study in primary care.Setting1243 practices contributing data to the QResearch database in England.Participants469,688 patients with type 2 diabetes aged 25-84 years between 1 April 2007 and 31 January 2015.ExposuresHypoglycaemic agents (glitazones, gliptins, metformin, sulphonylureas, insulin, and other) alone and in combination.Main outcome measuresFirst recorded diagnoses of amputation, blindness, severe kidney failure, hyperglycaemia, and hypoglycaemia recorded on patients' primary care, mortality, or hospital records. Cox models estimated hazard ratios for diabetes treatments adjusting for potential confounders.Results21,308 (4.5%) and 32,533 (6.9%) patients received prescriptions for glitazones and gliptins during follow-up, respectively. Compared with non-use, glitazones were associated with a decreased risk of blindness (adjusted hazard ratio 0.71, 95% confidence interval 0.57 to 0.89; rate 14.4 per 10,000 person years of exposure) and an increased risk of hypoglycaemia (1.22, 1.10 to 1.37; 65.1); gliptins were associated with a decreased risk of hypoglycaemia (0.86, 0.77 to 0.96; 45.8). Although the numbers of patients prescribed gliptin monotherapy or glitazones monotherapy were relatively low, there were significantly increased risks of severe kidney failure compared with metformin monotherapy (adjusted hazard ratio 2.55, 95% confidence interval 1.13 to 5.74). We found significantly lower risks of hyperglycaemia among patients prescribed dual therapy involving metformin with either gliptins (0.78, 0.62 to 0.97) or glitazones (0.60, 0.45 to 0.80) compared with metformin monotherapy. Patients prescribed triple therapy with metformin, sulphonylureas, and either gliptins (adjusted hazard ratio 5.07, 95% confidence interval 4.28 to 6.00) or glitazones (6.32, 5.35 to 7.45) had significantly higher risks of hypoglycaemia than those prescribed metformin monotherapy, but these risks were similar to those involving dual therapy with metformin and sulphonylureas (6.03, 5.47 to 6.63). Patients prescribed triple therapy with metformin, sulphonylureas, and glitazones had a significantly reduced risk of blindness compared with metformin monotherapy (0.67, 0.48 to 0.94).ConclusionsWe have found lower risks of hyperglycaemia among patients prescribed dual therapy involving metformin with either gliptins or glitazones compared with metformin alone. Compared with metformin monotherapy, triple therapy with metformin, sulphonylureas, and either gliptins or glitazones was associated with an increased risk of hypoglycaemia, which was similar to the risk for dual therapy with metformin and sulphonylureas. Compared with metformin monotherapy, triple therapy with metformin, sulphonylureas, and glitazones was associated with a reduced risk of blindness. These results, while subject to residual confounding, could have implications for the prescribing of hypoglycaemic drugs.

Dataset Information

HbA1c and hypoglycaemia in intensively treated type 2 diabetes: a retrospective cohort study in primary care.

Objective

Design

Setting

Participants

Main outcome measures

Results

Conclusions

Publications

HbA1c and hypoglycaemia in intensively treated type 2 diabetes: a retrospective cohort study in primary care.

Similar Datasets

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