Increase in the incidence of severe hypoglycaemia in people with Type 2 diabetes in spite of new drugs: analysis based on health insurance data from Germany.

AIM: To evaluate the use of new anti-hyperglycaemic agents that offer effective glycaemic control while reducing risk of hypoglycaemia, by analysing the incidence rates of severe hypoglycaemia in 2006 vs 2011 in relation to the medication. METHODS: This cross-sectional, population-based study used German health insurance data. All adults diagnosed with Type 2 diabetes mellitus (extrapolated to the German population: 6.35 million in 2006 and 7.52 million in 2011) were screened for severe hypoglycaemia. Anti-hyperglycaemic agents were identified by their Anatomical Therapeutic Chemical code, and defined daily doses of each medication were calculated. RESULTS: The severe hypoglycaemic event rate was 460 per 100,000 people/year in 2006 and 490 per 100,000 people/year in 2011. In 2006 and 2011, 10.9% and 7.3%, respectively, of all people with severe hypoglycaemia were on sulfonylureas, while 12.7% and 9.3%, respectively, were on a combination therapy of metformin and sulfonylureas. Among those with severe hypoglycaemia, there were no prescriptions of dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 receptor agonists in 2006, but in 2011, 1.55% and 0.17%, of those with severe hypoglycaemia were receiving the respective treatments. In 2006 vs 2011, human insulin was prescribed for 11.3% vs 10.3% of people with severe hypoglycaemia, while insulin analogues were prescribed for 5.4% vs 8.1%, and mixed human insulins for 19.7% vs 14.0% of patients with severe hypoglycaemia. People receiving insulin analogue therapy had a higher risk of severe hypoglycaemia than those receiving metformin, after adjusting for age, gender, nephropathy diagnosis and year of survey (odds ratio 14.6; CI 13.3-15.9). CONCLUSION: The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, despite increased use of newer anti-hyperglycaemic agents and decreased use of insulins.

Diabetes-related burden and distress in people with diabetes mellitus at primary care level in Germany.

AIMS: The importance of diabetes-related distress for the treatment of diabetes is emphasised in national and international guidelines recommending routinely screening for psychosocial problems. Data of investigations regarding diabetes-related distress on primary care are rare in Germany though most people with diabetes are treated without insulin therapy at primary care level. METHODS: Three hundred and forty-five people with diabetes mellitus type 2 (DM2, n = 336, 229 without and 107 with insulin therapy) and type 1 (DM1, n = 9) were interviewed with the PAID questionnaire in the period from 1 October 2015 to 31 December 2015 in a general practice. A PAID score ≥40 (range 0-100) was considered as high diabetes-related distress. RESULTS: The mean PAID score of all participants was 3.9 ± 7.0 (DM2 without insulin 2.7 ± 6.3, DM2 with insulin therapy 6.0 ± 8.0, DM1 6.8 ± 4.9) and far below the threshold of 40 points. Only 1.2% of all responders showed high diabetes-related distress (score ≥40). People on insulin therapy with HbA1c >7.5% and with diagnosed depression prior to the study scored significantly higher. Furthermore, there are weak correlations between the PAID score and HbA1c (r = 0.253, p < 0.001), duration of diabetes (r = 0.169, p = 0.002), insulin dosage (r = 0.283, p < 0.001) and age (r = -0.129, p = 0.016). CONCLUSIONS: Only 1.2% of our outpatients with diabetes on primary care level showed high diabetes-related distress. Higher rates in the current literature are probably due to not investigating on primary care level. Guidelines should consider this.

Principles of self-adjustment of insulin dose in people with diabetes type 2 and flexible insulin therapy.

AIMS: Structured treatment and education programmes for people with type 2 diabetes mellitus (T2DM) and flexible insulin therapy provide rules for self-adjustment of insulin dose, that are extensively trained. The aim of this cohort study was to register current principles and the frequency of self-adjustment of insulin dose and their association with metabolic control in people with T2DM. METHODS: Details of insulin dose adjustment were assessed by a structured interview in 149 people with T2DM on flexible insulin therapy (mean HbA1c 7.1%/53.8mmol/mol, age 65y, diabetes duration 19.0y, BMI 33.8kg/m(2)) in a tertiary care centre. The frequency of insulin dose adjustments was obtained from the last 28days of the patients' diaries. RESULTS: Insulin dose adjustment by adjustment rules was used by 33 people (22.1%) and by personal experience/feeling in 111 participants (74.5%). People adjusting by rules were younger (60.9±9.8 vs. 65.7±9.2, p=0.011) and did more insulin dose adjustments per 28days (50.0±31.0 vs. 33.4±23.5, p=0.016). HbA1c and incidence of hypoglycaemia were comparable. There were no differences in satisfaction of treatment, quality of life as well as current well-being between the groups. CONCLUSIONS: Only a fifth of the participants used the rule trained within the education programme to adjust their insulin dose. The majority adjusted their insulin dose by personal experience/feeling. However, people in both groups were able to adjust their insulin dose. Although people using adjustment rules adjust their insulin dose more frequently, HbA1c and the incidence of hypoglycaemia was similar compared to those using personal experience/feeling.

Diabetes-Related Burden and Distress is Low in People with Diabetes at Outpatient Tertiary Care Level.

OBJECTIVE: The importance of diabetes-related distress (DRD) for the treatment of diabetes is emphasized in national and international guidelines recommending routinely screening for psychosocial problems. To detect DRD, the PAID (Problem Area In Diabetes) questionnaire provides a valid and reliable instrument. RESEARCH DESIGN AND METHODS: 783 patients with diabetes mellitus type 1 (DM1, n=191, age 54.5 y, diabetes duration 22.5 y, HbA1c 7.2% (55 mmol/mol)) and type 2 (DM2, n=592, age 66.6 y, diabetes duration 15.6 y, HbA1c 7.0% (60.1 mmol/mol)) were interviewed with the PAID and WHO-5 questionnaire in a University outpatient department for endocrinology and metabolic diseases in 2012. A PAID score≥40 (range 0-100) was considered as high DRD. RESULTS: The mean PAID score was 17.1±15.1 in all participants. Only 8.9% of all responders showed high DRD (score≥40). The PAID score neither differed in people with DM1 and DM2, nor between participants with DM2 with or without insulin therapy. Females achieved significantly higher scores than men (19.0±16.6 vs. 15.6±13.7, p=0.003). A strong negative correlation existed between the PAID score and the WHO-5 Well-being Index (r=- 0.482, p<0.001). A 10 points higher WHO-5 Well-being Index was associated with 15.9 points lower PAID score in people with DM1 (p<0.001), and 9.2 points lower PAID score in DM2 (p<0.001), respectively. One percent higher HbA1c was associated with an increase of diabetes-related distress by 2.5 points in people with DM1 and by 2.0 points in people with DM2. CONCLUSIONS: Less than 10% of our outpatients with diabetes showed high diabetes-related distress.

Metabolic control and hypoglycaemia in people with type 2 diabetes on conventional or intensified insulin therapy: a 22 year retrospective single centre survey.

BACKGROUND: Multiple insulin injection therapy can easily be adapted to the patient's needs. Therefore, it is supposed that more intensive insulin therapy is associated with better metabolic control and less hypoglycaemia compared with a conventional insulin strategy in patients with type 2 diabetes. METHODS: HbA1c and incidence of non-severe and severe hypoglycaemia were analysed with regard to the strategy of insulin therapy [multiple insulin injection therapy with preprandial insulin with or without basal insulin or conventional insulin therapy with twice-daily premix insulin] from 20 943 visits of 1417 people treated with insulin with type 2 diabetes in a university outpatient department for endocrinology and metabolic diseases over a period of 22 years. RESULTS: Multiple insulin injection therapy was used in 13 896 (66.4%) of all 20 942 visits. Compared with conventional insulin therapy, these patients were younger (62.0 vs 68.7 years; p < 0.001), had a slightly longer diabetes duration (16.5 vs 15.8 years; p < 0.001) and higher body mass index (32.8 vs 30.9 kg/m(2) ; p < 0.001), a higher insulin dose (76.4 vs 46.5 IU/day; p < 0.001), more frequent blood glucose monitorings/week (24.2 vs 14.8; p < 0.001), a slightly lower HbA1c [7.7 (61.2) vs 7.9% (62.9 mmol/mol); p < 0.001] but more non-severe hypoglycaemic incidences per week (0.3 vs 0.2; p = 0.01). Episodes of severe hypoglycaemia were rare and comparable (0.01/patient/year) with both insulin therapy strategies. CONCLUSIONS: Multiple insulin injection therapy and conventional insulin therapy yielded comparable metabolic control with HbA1c below 8% (63.9 mmol/mol), but multiple insulin injection therapy is associated with higher body mass index and higher incidence of non-severe hypoglycaemia. Copyright © 2016 John Wiley & Sons, Ltd.