T Heller

Retinal Vessel Oxygen Saturation under Flicker Light Stimulation in Patients with Nonproliferative Diabetic Retinopathy

PURPOSE We investigated the response of retinal vessel diameters and oxygen saturation to flicker light stimulation of neuronal activity in patients with diabetic retinopathy. METHODS We included 18 patients with nonproliferative diabetic retinopathy (mean age 62.2 ± 8.3 years, diabetes type 1 in 4 patients and type 2 in 14, hemoglobin A1c 7.7 ± 0.9%, duration of diabetes 24.1 ± 9.3 years) and 20 age-matched healthy controls (age 66.7 ± 10.3 years). Dual wavelength (548 and 610 nm) fundus images were taken before and during luminance flicker stimulation (12.5 Hz, modulation depth > 1:25) for 90 seconds. Diameters (central retinal arterial [CRAE] and venous [CRVE] equivalents) and oxygen saturation (SO(2)) were determined, and averaged for all arterioles and venules in an annular area centered at the optic disk. RESULTS Flicker light increased CRAE, CRVE, and venous SO(2) by 0.6 ± 6.6%, 2.7 ± 6.1%, and 2.0 ± 2.4% (P < 0.05), respectively, in the patients as well as 4.7 ± 8.4% (P < 0.05), 8.7 ± 5.2% (P < 0.05), and 4.2 ± 3.5% (P < 0.05), respectively, in the controls. The arterial SO(2) remained unchanged in both groups. The increase of the venous SO2 correlated significantly (P = 0.027) with that of the CRAE. There was a trend (P = 0.06) for lower increase of the venous SO(2) with higher body mass index. CONCLUSIONS Our results support the thesis of an impaired regulation of oxygen supply to the diabetic retina. Whereas in healthy subjects the stimulation of neuronal activity increases the vascular diameters and, subsequently, the oxygen supply, this increase is reduced in diabetic retinopathy. This may hint at the role of endothelial dysfunction in the etiology of the disease.

A retrospective study on the incidence and risk factors of severe hypoglycemia in primary care

AIMS To investigate the incidence and risk factors of severe hypoglycemia (SH) in primary care. SH was defined as hypoglycemia with coma, or the need of glucose or glucagon injection. METHODS We performed a cross-sectional retrospective study in patients with diabetes treated in primary care in Germany. We analyzed an unselected sample of participants with type 1 (n = 373) and type 2 diabetes (n = 4481) who participated in an insurance plan from the health care insurer Deutsche BKK. Data of participants with type 1 diabetes are as follows: women, n = 155 (42%); age, 49±16 years; diabetes duration, 20+13 years; BMI, 28±6 kg/m2; GHb, 7.1+1.5%; GHb≤7%, n = 263 (71%); GHb≥8.5%, n = 48 (13%). Data of participants with type 2 diabetes: women, n = 1979 (44%); age, 66±10 years; diabetes duration, 8±7 years; BMI, 30±5 kg/m2; GHb, 6.6±1.3%; GHb≤7%, n = 3747 (84%); GHb≥8.5%, n = 360 (8%); insulin therapy, n = 1175 (26%). RESULTS The incidence of SH in type 1 diabetes: 1.3% (CI: 0.4%, 3.1%) per year; type 2 diabetes with insulin therapy: 0.9% (CI: 0.5%, 1.7%); without insulin therapy: 0.3% (CI: 0.1%, 0.6%). The event rate was 0.02 SH per patient/year in type 1 diabetes and 0.01 in type 2 diabetes, respectively. Low BMI, GHb, insulin therapy and female gender were associated with an increased risk of SH. CONCLUSIONS In primary care, patients with diabetes can achieve good glycemic control with very rare events of SH. Due to low incidence, SH would have been an inappropriate parameter to evaluate the outcome quality of diabetes therapy in primary care.

Informed shared decision-making programme on the prevention of myocardial infarction in type 2 diabetes: a randomised controlled trial

Objective To evaluate an informed shared decision-making programme (ISDM-P) for people with type 2 diabetes under high fidelity conditions. Design Randomised, single-blinded trial with sham control intervention and follow-up of 6 months. Setting Single-centre diabetes clinic providing care according to the national disease management programme in Germany. Participants 154 people with type 2 diabetes without diagnosis of ischaemic heart disease or stroke. Interventions The ISDM-P is executed by diabetes educators. Core component is a patient decision aid on the prevention of myocardial infarction supplemented by a 90 min group teaching session. The structurally equivalent control intervention addresses stress issues. Main outcome measures Primary outcome was risk comprehension, including realistic expectations about benefits and harms of interventions. It was assessed by a 12-item questionnaire after the teaching session when patients set and prioritise their treatment goals. Key secondary outcome was adherence to treatment goals, operationalised as achievement of individual goals and medication uptake. ISDM-P teaching sessions were video-taped to monitor intervention fidelity. Results 72 of 77 ISDM-P and 71 of 77 control patients completed the questionnaire (score 0–12). ISDM-P patients achieved higher levels of risk comprehension, mean score 8.25 vs 2.62, difference 5.63 (95% CI 4.82 to 6.44), and realistic expectations (score 0–6), 4.51 vs 0.85, 3.67 (3.23 to 4.11). More ISDM-P patients wished to take statins, 59.2% vs 30.4%, 28.7% (12.9% to 44.5%); more prioritised blood pressure control, 51.4% vs 25.7%, and fewer intensive glucose control, 33.3% vs 60%, p=0.002. More ISDM-P patients achieved their glycated haemoglobin goals, 95.8% vs 85.7%, 10.1% (0.6% to 19.5%). Achievement of prioritised goals and medication uptake were comparable between groups. Conclusions The ISDM-P on preventive measures in type 2 diabetes was effective under high fidelity conditions. Involvement of diabetes educators may facilitate implementation of the informed shared decision-making. Trial registration number ISRCTN84636255.

Mortality and its Causes in a German Cohort with Diabetes Mellitus Type 1 after 20 Years of Follow-Up: The JEVIN Trial

BACKGROUND The JEVIN trial started as a cross-sectional study in 1989/90 in Jena. After a follow-up of more than 20 years, the mortality incidence of JEVIN participants with type 1 diabetes was surveyed. METHODS 103 (78.6%) of the 131 JEVIN patients participating at baseline could be examined. 38 persons (36.9%) had deceased. All JEVIN survey data and routine examinations documented in the electronic patient record EMIL® of surviving and deceased participants were used for analyses. We compared the data of the surviving with the deceased participants (follow-up time: 2,166 person-years). RESULTS The incidence rate of death was 1.75/100 person-years. Median observation time for all patients was 23.1 years (range 0.61-26.6 years). Mean age at death was 58.5 years (34.2-78.4 years), and diabetes duration 35 years (3.5-68.5 years). Most frequent causes of death were: cardiovascular diseases (48.2%, n=13) and infections (25.9%, n=7). There were no differences in age (p=0.302), diabetes duration (p=0.371), BMI (p=0.535), blood pressure (p=0.622/0.820), gender (p=0.566), and smoking status (p=0.709) between surviving and deceased persons. The mean HbA1c of the last year before death or last visit was higher in the deceased than surviving persons (7.5% vs. 7.0%; p=0.010). 57.4% of the surviving and 87.0% of the deceased participants had nephropathy (p=0.012), 79.7% vs. 89.7% retinopathy (p=0.241) and 61.4% vs. 63.3% neuropathy (p=0.860), but only nephropathy was significantly associated with increased mortality risk (HR=4.208, CI:1.226-14.440; HR=2.360, CI:0.696-8.004; HR=0.944, CI:0.436-2.043). CONCLUSIONS In the JEVIN population with diabetes mellitus type 1 only, diabetic nephropathy was associated with higher mortality risk.

Changes in Quality of Diabetes Care and Morbidity over 20 Years in People with Type 1 Diabetes and Long Diabetes Duration: The JEVIN Trial

Background: The JEVIN trial started as a cross-sectional study in 1989/90 in Jena, a city of the former German Democratic Republic. At that time, the centralized diabetes care system was broken down and restarted 10 years later; structured treatment and teaching programs were implemented, blood glucose self-monitoring, insulin pump-systems and analogue insulin were introduced. We surveyed people with type-1-diabetes of the baseline JEVIN trial in a 20-year follow-up. Methods: 131 patients with type-1-diabetes were analyzed in 1989/90. Of the living population in 2009/10 (n=104), 83 persons were identified and 75 persons with a mean diabetes duration of 35 years were reexamined regarding HbA1c, self-monitoring, diabetes therapy, severe hypoglycemia, diabetic late complications and compared with the results of the same persons in 1989/90. Results: HbA1c decreased from 57.1 mmol/mol in 1989/90 to 52.7 mmol/mol in 2009/10 (7.4 -7.0%; p=0.049). Self-monitoring of blood glucose increased from 2 to 35 tests/week (p<0.001). 100%-use of animal insulin changed to human and analogue insulin therapy. The incidence of severe hypoglycemia increased from 0.1 to 0.16/patient-year. Retinopathy increased from 29 to 69% (p<0.001), nephropathy from 5 to 27% (p<0.001) and neuropathy from 13 to 43% (p<0.001). 17% had no diabetic late complications. Conclusions: The JEVIN trial shows a significant improve in HbA1c in the past 20 years. Severe hypoglycemia occurred rarely and 17% were still free of any diabetic late complication after 35 years of diabetes. This indicates a good quality of diabetes care in a German setting.

Snacking is Common in People with Diabetes Type 1 and Type 2 with Insulin Therapy and Is Not Associated With Metabolic Control or Quality of Life

OBJECTIVE The aim of this observational study was to analyse snacking pattern and satisfaction with snacking, and to associate snacking patterns with metabolic control and quality of life in people with diabetes type 1 and 2 on insulin therapy. METHODS In 2017, 390 people with diabetes were interviewed in a university outpatient department: 132 diabetes type 1 (56.1y, diabetes duration 24.2y, HbA1c 7.0%), 89 diabetes type 2/biphasic insulin (72.8y, diabetes duration 22.0y, HbA1c 7.1%) and 169 diabetes type 2/prandial insulin (66.7y, diabetes duration 20.5y, HbA1c 7.0%). Standardised questionnaires were used to assess eating patterns, satisfaction with snacking, treatment satisfaction and quality of life. RESULTS The far majority snacked regardless of diabetes type and type of insulin therapy (70.5% type 1, 80.9% type 2/biphasic insulin, 74.6% type 2/prandial insulin) and liked to do so or did not mind (type 1 diabetes 79.5%, type 2 diabetes/biphasic insulin 84.8%, type 2 diabetes/prandial insulin 83.5%). Snacking because of recommendations of healthcare professionals was rare (10.8% type 1 diabetes, 8.2% type 2 diabetes/biphasic insulin, 9.4% type 2 diabetes/prandial insulin). Snacking and not snacking participants did not differ in respect to HbA1c, quality of life or treatment satisfaction. CONCLUSIONS Snacking seems to be a common habit in individuals with diabetes and most of them like to snack. Snacking is not associated with better or worse metabolic control or quality of life. The decision to snack or not to snack can be left to the individual and integrated into the therapy without danger for the glycaemic control.