Hemoglobin A1c Levels and Risk of Severe Hypoglycemia in Children and Young Adults with Type 1 Diabetes from Germany and Austria: A Trend Analysis in a Cohort of 37,539 Patients between 1995 and 2012

Karges, Beate; Rosenbauer, Joachim; Kapellen, Thomas; Wagner, Verena; Schober, Edith; Karges, Wölfram; Holl, Reinhard W.

doi:10.1371/journal.pmed.1001742

Cited by 133 publications

(162 citation statements)

References 36 publications

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“…No association between lower HbA1c and hospital admission rate for severe hypoglycemia was found, similar to other reports (9,13). These results correspond to our previous findings in young individuals with type 1 diabetes that low HbA1c no longer predicts the risk of severe hypoglycemia (8).…”

Section: European Journal Of Endocrinologysupporting

confidence: 91%

“…The Diabetes Patienten Verlaufsdokumentation (DPV) Prospective Documentation Initiative of diabetes care in Germany has prospectively followed patients with diabetes mellitus since 1995 (1,8). Analysis of anonymized data was approved by the Ethics Committee of Ulm University, Ulm, Germany.…”

Section: Methodsmentioning

confidence: 99%

“…glucose (11). HbA1c values were mathematically standardized to the DCCT reference range 4.05-6.05% using the multipleof-the-mean transformation method (8). For each patient, HbA1c values were averaged per year of follow-up.…”

Section: Methodsmentioning

confidence: 99%

“…Diabetic ketoacidosis (DKA) accounts for 13% (2,3) to 19% (4) of disease-related mortality and occurs at a rate of 1-10/100 patient-years in children and adolescents with established diabetes remaining largely constant within the last decade (1,5,6,7). In contrast, the incidence of severe hypoglycemia has decreased during the past decade and recent reports refer to rates of 16-20/100 patient-years for severe hypoglycemia (defined as requiring assistance from another person) and 2-8/100 patient-years for hypoglycemic coma (loss of consciousness or seizures) (1,7,8,9,10,11), accounting for 4-10% (2, 3, 4, 12) of diseaserelated mortality.…”

Section: Introductionmentioning

confidence: 99%

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Hospital admission for diabetic ketoacidosis or severe hypoglycemia in 31 330 young patients with type 1 diabetes

Karges

Rosenbauer

Holterhus

et al. 2015

European Journal of Endocrinology

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Objective: To investigate rates and risk factors of hospital admission for diabetic ketoacidosis (DKA) or severe hypoglycemia in young patients with established type 1 diabetes. Design: In total, 31 330 patients with type 1 diabetes (median age 12.7 years) from the Diabetes Patienten Verlaufsdokumentation (DPV) Prospective Diabetes Registry treated between 2011 and 2013 in Germany were included. Methods: Admission rates for DKA (pH !7.3 or bicarbonate !15 mmol/l) and severe hypoglycemia (requiring assistance from another person) were calculated by negative binomial regression analysis. Associations of DKA or hypoglycemia with patient and treatment characteristics were assessed by multivariable regression analysis. Results: The mean admission rate for DKA was 4.81/100 patient-years (95% CI, 4.51-5.14). The highest DKA rates were observed in patients with HbA1c R9.0% (15.83 (14.44-17.36)), age 15-20 years (6.21 (5.61-6.88)) and diabetes duration of 2-4.9 years (5.60 (5.00-6.27)). DKA rate was higher in girls than in boys (5.35 (4.88-5.86) vs 4.34 (3.95-4.77), PZ0.002), and more frequent in migrants than in non-migrants (5.65 (4.92-6.49) vs 4.57 (4.23-4.93), PZ0.008). The mean admission rate for severe hypoglycemia was 1.45/100 patient-years (1.30-1.61). Rates were higher in migrants compared to non-migrants (2.13 (1.72-2.65) vs 1.28 (1.12-1.47), P!0.001), and highest in individuals with severe hypoglycemia within the preceding year (17.69 (15.63-20.03) vs patients without preceding hypoglycemia 0.42 (0.35-0.52), P!0.001). Differences remained significant after multivariable adjustment. Conclusions: The identification of at-risk individuals for DKA (patients with high HbA1c, longer diabetes duration, adolescents, girls) and for severe hypoglycemia (patients with preceding severe hypoglycemia, migrants) may facilitate targeted diabetes counselling in order to prevent these complications.

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Section: European Journal Of Endocrinologysupporting

confidence: 91%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Hospital admission for diabetic ketoacidosis or severe hypoglycemia in 31 330 young patients with type 1 diabetes

Karges

Rosenbauer

Holterhus

et al. 2015

European Journal of Endocrinology

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“…However, a number of more recent studies have not confirmed the strong association between optimization of glycemic control and an increase in risk of SH in children, adolescents, and adults. [18][19][20][21][22][23][24] Nevertheless, CGM might be a technical solution assisting the achievement of both treatment goals. It is of interest to note that in a recent publication no indication was found that CGM usage reduces SH, fear of hypoglycemia, hypoglycemia awareness, or even biochemical hypoglycemia.…”

Section: Risk Of Hypoglycemic Events In Patients With Type 1 Diabetesmentioning

confidence: 99%

HypoDE

Heinemann

Deiss

Hermanns

et al. 2015

J Diabetes Sci Technol

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The evidence for continuous glucose monitoring (CGM) to improve HbA1c without increasing the risk of hypoglycemic events has been established. Yet, after more than a decade of availability, the evidence for usage of CGM to reduce the risk of hypoglycemic events (especially of severe hypoglycemic events [SH]) from a number of studies remains under debate.1-6 However, in many of these studies first generations CGM systems were used; the analytical performance, reliability, and usability of these systems were considerably worse than more recent CGM system generations. Although real-time CGM per se (that mean CGM only, without communicating with an insulin pump; subsequently the term CGM will be used in this sense) has been shown to reduce the amount of time a user spends at low glucose, it has not demonstrated to be effective in reducing such low glucose events in general and nocturnal events during sleep. [5][6][7][8] In most studies performed to date, CGM systems were used by patients with type 1 diabetes that utilize continuous subcutaneous insulin infusion therapy (CSII) by means of insulin pumps, there is less data on patients using multiple daily injection (MDI) therapy by means of syringes or pens AbstractSystems for continuous glucose monitoring (CGM) have been available for a number of years, and numerous clinical studies have been performed with them. Interestingly, in many of these studies patients with an increased risk of hypoglycemic events were excluded. In addition, in most studies subjects were using a pump for insulin delivery. Therefore our knowledge about the benefit of CGM in patients employing multiple daily injections (MDI) of insulin is limited, especially when it comes to a reduction in the risk of low glucose events in high-risk individuals. We are planning to run a 26-week randomized controlled study in Germany (HypoDE, Hypoglycemia in Deutschland) that is focused on evaluating if such a reduction can be observed in patients on MDI with an increased risk of low glucose events. In all, 160 patients will participate in the study, randomized into the intervention group and control group. Ideally one would study if the frequency of severe hypoglycemic events is different between both groups. However, this would require such a large sample size and study duration, so for pragmatic reasons we will use low glucose levels <55 mg/dl (measured by CGM) for at least 20 minutes as a risk marker for severe hypoglycemic events. The results from the HypoDE study shall help determine the advantage of using CGM in subjects with type 1 diabetes with an increased risk of low glucose events treated with MDI.

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Association of Insulin Pump Therapy vs Insulin Injection Therapy With Severe Hypoglycemia, Ketoacidosis, and Glycemic Control Among Children, Adolescents, and Young Adults With Type 1 Diabetes

Karges

Schwandt

Heidtmann

et al. 2017

JAMA

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371

247

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Among young patients with type 1 diabetes, insulin pump therapy, compared with insulin injection therapy, was associated with lower risks of severe hypoglycemia and diabetic ketoacidosis and with better glycemic control during the most recent year of therapy. These findings provide evidence for improved clinical outcomes associated with insulin pump therapy compared with injection therapy in children, adolescents, and young adults with type 1 diabetes.

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Hemoglobin A1c Levels and Risk of Severe Hypoglycemia in Children and Young Adults with Type 1 Diabetes from Germany and Austria: A Trend Analysis in a Cohort of 37,539 Patients between 1995 and 2012

Abstract: In a cohort study, Beate Karges and colleagues find that the association between low hemoglobin A1C and severe hypoglycemia in children and young adults with type 1 diabetes has decreased over the period between 1995 and 2012. Please see later in the article for the Editors' Summary

Cited by 133 publications

References 36 publications

Hospital admission for diabetic ketoacidosis or severe hypoglycemia in 31 330 young patients with type 1 diabetes

Hospital admission for diabetic ketoacidosis or severe hypoglycemia in 31 330 young patients with type 1 diabetes

HypoDE

Association of Insulin Pump Therapy vs Insulin Injection Therapy With Severe Hypoglycemia, Ketoacidosis, and Glycemic Control Among Children, Adolescents, and Young Adults With Type 1 Diabetes

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