A Randomized Controlled Trial to Assess the Feasibility and Practicability of an Oatmeal Intervention in Individuals with Type 2 Diabetes: A Pilot Study in the Outpatient Sector.

Background/Objectives: The aim of this study was to investigate the feasibility and practicability of repeated three-day sequences of a hypocaloric oat-based nutrition intervention (OI) in insulin-treated outpatients with type 2 diabetes and severe insulin resistance. Methods: A randomized, two-armed pilot study was conducted with three months of intervention and three months follow-up with 17 participants with insulin resistance (≥1 IU/kg body weight). Group A (n = 10) performed one sequence of OI; Group B (n = 7) performed two sequences monthly. A sequence was 3 consecutive days of oat consumption with approximately 800 kcal/d. The main objective was to assess feasibility (≥70% completers) and practicability regarding performance aspects. Biomedical parameters such as HbA1 c were observed. To evaluate the state of health, a standardized questionnaire was used (EQ-5 D). Results: OI was feasible (13/17 completer participants (76.5%): 70.0% Group A, 85.7% Group B). Individually perceived practicability was reported as good by 10/16 participants (62.5%). Total insulin dosage decreased from 138 ± 35 IU at baseline to 126 ± 42 IU after OI (p = 0.04) and 127 ± 42 IU after follow-up (p = 0.05). HbA1 c was lower after OI (-0.3 ± 0.1%; p = 0.01) in all participants. Participants in Group B tended to have greater reductions in insulin (Δ-19 IU vs. Δ-4 IU; p = 0.42) and weight loss (Δ-2.8 kg vs. Δ-0.2 kg; p = 0.65) after follow-up. Severe hypoglycemia was not observed. EQ-5 D increase not significantly after follow-up (57.2 ± 24.0% vs. 64.7 ± 21.5%; p = 0.21). Conclusions: The feasibility and practicability of OI in outpatients were demonstrated. OI frequency appears to correlate with insulin reduction and weight loss. Proper insulin dose adaptation during OI is necessary. Presumably, repeated OIs are required for substantial beneficial metabolic effects.

[Evaluation of electronic medical records from general practices using the example of the diagnosis of community-acquired pneumonia: A qualitative feasibility study]. / Nutzung von Daten aus dem Praxisverwaltungssystem eines großen hausärztlichen Verbundes medizinischer Versorgungszentren am Beispiel der Diagnosestellung einer ambulant erworbenen Pneumonie ­ eine qualitative Machbarkeitsstudie.

BACKGROUND: Data collected by general practitioners (GPs) may provide potential for health services research. In this study, we investigated if clinical questions can be answered with GPs' electronic medical records (EMRs) by means of diagnosing community-acquired pneumonia (CAP). METHOD: Patients diagnosed with CAP, defined as ICD code J18.9, were identified in the fourth quarter of 2021. The data were derived from the EMR system (Medical Office®) of a central German association of 30 general practices, using three different approaches: 1. The integrated statistic tool was used to record whether patients were referred for radiological diagnostic confirmation. 2. Retrospectively, EMRs were evaluated manually by a doctor familiar with the EMR. 3. The raw data of the EMR system were extracted by automated export. The information obtained through the three types of access was compared. For each patient case, detailed comments on problems and specifics were documented and evaluated by qualitative content analysis (QCA) according to Mayring. RESULTS: In total, 164 patients diagnosed with CAP were identified. The numbers of documented radiological diagnostic confirmations varied between data approaches: While the manual evaluation of the EMRs revealed 60 referred patients, the statistics tool identified 38 of these cases. The export of the raw data identified 58 referrals to radiography after adjustment. According to QCA, there was a high variation in applied diagnostics and time of diagnosis. Referrals for radiography were made both before and after coding of the diagnosis. In case of hospitalization, X-rays were usually performed during the inpatient stay. Laboratory tests were performed as an alternative to radiography. There was also a high variation in the documentation of risk factors and diagnostic certainty. DISCUSSION: The statistics tool integrated into the EMR system is a quick way to perform simple queries but proved to be impracticable for complex questions. The EMRs provide detailed information but need to be evaluated manually. An automated data export from the raw data offers both detailed information and access to large volumes of data but requires complex preparation and appropriate IT expertise. CONCLUSION: Based on the example of diagnosed CAP in a GP setting, the use of data extracted from an EMR system seems to be feasible to answer simple clinical questions. However, it is necessary to adapt the data export, and a comparison with a small number of manually evaluated cases is useful to achieve valid results.

Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire.

OBJECTIVE: Fear of diabetes complications (FDC) is a common source of emotional distress in people with diabetes across types and treatments and may affect health outcomes. To assess FDC, the Fear of Diabetes Complications Questionnaire (FDCQ) was developed. This study evaluates the FDCQ's German version in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHOD: A German version of the FDCQ was developed and administered as part of four different studies sampling people with T1D and T2D. Measurement properties were evaluated across studies using factor analyses, reliability estimates, and associations of the measure within a network of variables. A cutoff criterion for elevated FDC was derived. A short form scale was also developed. RESULTS: High reliability and validity were supported. FDC as measured by the FDCQ was independently associated with higher diabetes distress and depressive symptoms. A cut-off score for elevated FDC was set at ≥30 in the 15-item FDCQ. Elevated FDCQ scores were detected in 36% of participants in secondary diabetes care and up to 46% of those in tertiary care. CONCLUSIONS: FDC is prevalent in people with T1D and T2D and associated with diabetes distress and depressive symptoms. The FDCQ is a reliable and valid tool for assessing FDC in research and practice. It may help identify persons in need of tailored education and care and monitor effects following treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Screening Results for Diabetic Retinopathy in Germany in a Real-world Cohort in a Metropolitan Diabetes Care Center.

BACKGROUND: Retinal screening is mandatory to prevent vision loss and blindness due to diabetic retinopathy (DR). The aim of the study was to determine retinopathy screening rates and potential barriers in a German metropolitan diabetes care center. METHODS: Between May and October 2019, 265 patients with diabetes mellitus (95% type 2 diabetes; age 62±13.2 years; diabetes duration 11.1±8.5 years, HbA1c 7.4±1.0%) were referred to an ophthalmologist (referral form with order "Fundoscopy in diabetes mellitus, findings requested," completed documentation form "General practitioner's/diabetologist's report to the ophthalmologist" and prepared documentation form "Ophthalmologist's report"). A structured interview was used to assess the level of compliance with the guidelines and to identify potential barriers to retinopathy screening in a real-world setting, including the quantification of extra payments. RESULTS: All patients were interviewed at 7.9±2.5 months after the referral for retinopathy screening had been issued. According to patient reporting, fundoscopy was performed in 191 (75%) patients. Ophthalmological reports were obtained from 119/191 (62%) patients (46% of the entire cohort). 10/119 (8%) patients had been previously diagnosed with DR and 6/119 (5%) with new-onset DR. In 158/191 (83%) of patients, the referral had been accepted by the ophthalmology practice, of which 25,1% made a co-payment of 36.2±37.6 €. DISCUSSION: Despite a high screening performance in a real-world setting, complete screening in compliance with German guidelines, including written reporting, was found in less than half of the cohort. The prevalence and incidence of DR are high. Even when referred according to the regulations, one-quarter of patients made a co-payment. Efficient solutions to current barriers can emerge with mutual time-saving information prior to examination and feedback about the implementation of findings into treatment.

Choosing an insulin injector by a structured, pharmaceutical-neutral curriculum via an informed shared decision-making process in 349 insulin-naive patients with diabetes mellitus.

BACKGROUND: The national guideline for diabetes type 2 claims to involve patients in their decision-making on therapy. Unfortunately, no structured, pharmaceutical-neutral curriculum is available to guide patients in this shared decision-making (SDM) process regarding the insulin injector. The aim of the study was to evaluate which injector patients chose after SDM process and the reasons for their choice. METHODS: We developed a curriculum for a SDM process to choose an insulin injector for insulin-naive patients with diabetes mellitus, which took place immediately before the start of the initial treatment with insulin. It was conducted by a physician or diabetes educator with no conflicts of interest. All available human short-acting disposable insulin injectors (A, B and C) were handed out for try-out accompanied by individual counselling. The patients selected their injector of choice and were asked immediately afterwards about the criteria for their selection. RESULTS: 349 consecutive patients (94% diabetes type 2; age 58.6 + 13.4y; HbA1c 10.4 + 2.1%) were included. Patients choose Injector A in 10.0%, B in 61.9% and C in 28.1%. Criteria for selection were: design (41.8%), general impression (23.5%), dose window (7.7%), dose selection dial (7.4%), most practical (6.6%) and other (13%). Selection of a specific injector was not associated with age, diabetes type, diabetes duration, BMI, HbA1c, presence of concomitant diseases, retinopathy, neuropathy, diabetic foot or physician/diabetes educator. DISCUSSION: Insulin-naive patients with diabetes mellitus chose their own insulin injector within a newly developed structured SDM process to meet the national guideline. Main selection criteria were design and practicability.

[Participation rate of diabetes patients in structured education programs and reasons for non-participation: A cross-sectional survey among patients with diabetes mellitus in Thuringia]. / Teilnahmerate von Diabetespatient*innen an einer strukturierten Schulung und Gründe für eine Nicht-Teilnahme: eine querschnittliche Befragung von Patient*innen mit Diabetes mellitus in Thüringen.

BACKGROUND AND AIM: Structured education programs for patients with diabetes mellitus are an important and effective component of therapy. The aim of this survey is to assess the rate of participation in education programs in selected practices in Thuringia. Furthermore, we intend to identify factors that influence participation in order to derive strategies to increase participation. METHODS: Survey of patients with diabetes in Thuringian general practices and a diabetology practice using a newly developed questionnaire regarding "patient characteristics", "diabetes characteristics", "DMP and education programs" as well as reasons for non-participation in education programs and the wishes of non-educated patients. Data were analyzed using binary logistic regression analysis and other descriptive statistics in SPSS (IBM). RESULTS: Of the 1,254 questionnaires sent out, 637 (51%) were returned. Participation rate in education programs was 68% (n=405). HbA1c > 7.5%, diabetes sequelae, DMP participation and the awareness of education programs were significantly associated with participation in education programs. Recommendation/invitation to education programs, complex treatment regimes, long diabetes duration and urban practice led to a significant increase in the odds of attending an education program. Non-educated patients subjectively mentioned lack of need for training, lack of information, logistical reasons, and lack of time as reasons for non-participation. They expressed the wish for more information and recommendations from their general practitioner, shorter duration of education programs and online offerings. DISCUSSION: The participation rate in education programs was in the range of the evaluation reports on DMP programs for diabetes. Lower participation rates in rural areas may be explained by the lower physician density and especially education program offers as well as the more difficult accessibility. The factors and reasons for non-participation underline the need for comprehensive care and the general practitioner's key role in motivating, coordinating and educating patients. CONCLUSION: General practitioners play a central role in the care of patients with diabetes, and there is a need for comprehensive care and education programs. Telemedicine and digital applications can complement DMP and education programs.

Metabolic control and hypoglycaemia in people with type 1 diabetes: insulin pump therapy vs. intensified insulin therapy in an unselected cohort in routine care.

AIMS: The aim of this study was to compare individuals with type 1 diabetes with continuous subcutaneous insulin infusion (CSII) and intensified insulin therapy (ICT) in routine care regarding metabolic control and treatment satisfaction. METHODS: Individuals with type 1 diabetes (CSII n = 74; ICT n = 163) were analysed regarding metabolic control, frequency of hypoglycaemia and treatment satisfaction (DTSQs range 0-36). RESULTS: Individuals with CSII (duration of CSII: 14.1 ± 7.2 years) were younger (51.1 ± 15.8 vs. 56.2 ± 16.2 years, p = 0.023), had longer diabetes duration (28.7 ± 12.4 vs. 24.6 ± 14.3 years, p = 0.033), lower insulin dosage (0.6 ± 0.2 vs. 0.7 ± 0.4 IU/kg, p = 0.004), used more frequently short-acting analogue insulin (90.5% vs. 48.5%, p < 0.001) and flash/continuous glucose monitoring (50.0% vs. 31.9%, p = 0.009) than people with ICT. HbA1c was similar between CSII and ICT (7.1 ± 0.8%/54.4 ± 9.1 mmol/mol vs. 7.2 ± 1.0%/55.7 ± 10.9 mmol/mol, p = 0.353). Individuals with CSII had higher frequency of non-severe hypoglycaemia per week (in people with blood glucose monitoring: 1.9 ± 1.7 vs. 1.2 ± 1.6, p = 0.014; in people with flash/continuous glucose monitoring: 3.3 ± 2.2 vs. 2.1 ± 2.0, p = 0.006). Prevalence of polyneuropathy (18.9% vs. 38.0%, p = 0.004) and systolic blood pressure (138.0 ± 16.4 vs. 143.9 ± 17.1 mmHg, p = 0.014) was lower in CSII. Satisfaction with diabetes treatment (26.7 ± 7.3 vs. 26.0 ± 6.8, p = 0.600) did not differ between CSII and ICT. CONCLUSIONS: CSII and ICT yielded comparable metabolic control and treatment satisfaction but CSII was associated with higher incidence of non-severe hypoglycaemia and lower insulin dosage.

Diabetes related distress is high in inpatients with diabetes.

OBJECTIVE: The aim of the present study was to assess diabetes-related distress in inpatients and its association with metabolic control in people with diabetes type 1 (DM1) and type 2 (DM2). RESEARCH DESIGN AND METHODS: In a cross-sectional study, 107 inpatients with DM1 (age 45.9 years, diabetes duration 18.7 years, HbA1c 8.4%/67.8 mmol/mol) and 109 with DM2 (age 62.0 years, diabetes duration 16.2 years, HbA1c 8.9%/74.3 mmol/mol) from a University department for endocrinology and metabolic diseases (Germany) were included over 2 years. Diabetes-related distress was assessed with the PAID questionnaire (range 0-100, higher scores imply higher diabetes-related distress, cut-off ≥ 40). The PAID questionnaire was completed by 214 of 216 participants. RESULTS: Fifty-one of 214 individuals (23.8%) showed high distress (PAID score ≥ 40). The mean PAID score was 28.1 ± 17.5 in all participants with no difference between DM1 and DM2 (28.1 ± 17.4 vs. 26.2 ± 16.9, p = 0.532). Individuals with DM2 on insulin scored higher than patients without insulin (27.8 ± 17.6 vs. 18.7 ± 8.5, p = 0.004). Additionally, people with DM1 treated with a system for continuous glucose monitoring (n = 50, 33.1 ± 18.8) scored higher than participants without such system (n = 32, 20.6 ± 13.3, p = 0.001). HbA1c was not correlated with the PAID score in both, DM1 (r = 0.040, p = 0.684) and DM2 (r = - 0.024, p = 0.804). Participants with DM2 and severe hypoglycaemia/last 12 months scored higher than people without (PAID score 43.0 ± 20.4 vs. 25.1 ± 16.5, p = 0.026). Frequency of non-severe hypoglycaemia was not associated with the PAID score in DM1 and DM2. CONCLUSIONS: Patients with diabetes treated in hospital for problems with diabetes suffer frequently from diabetes-related distress (~ 24%) regardless of diabetes type.

Reduction of Severe Hypoglycaemia in People with Type 2 Diabetes after a Structured Inpatient Intervention.

OBJECTIVE: The aim of this longitudinal study was to assess outcomes before and one year after participation in a structured inpatient intervention including participation in an education programme for people with type 2 diabetes. METHODS: In 2014, 81 individuals, who were admitted to optimise insulin therapy, participated in a structured inpatient intervention and were invited to participate in a follow-up visit after one year. RESULTS: Seventy participants (46.9% female, age 68.3 y, diabetes duration 17.9 y, HbA1c 9.7%/82.5 mmol/mol) were followed-up after 1.2 y (3 died by non-diabetic causes, 8 declined/were not available). HbA1c decreased by 1.1% (p<0.001) without change of insulin dose (79.7 vs. 79.3 IU, n.s.) or BMI (33.6 vs. 33.8 kg/m2, n.s.). 5 people admitted because of severe hypoglycaemia (one person with 5 episodes and 4 with one episode in the year prior to participation) did not experience another event in the evaluation period, nor did anyone in the rest of the cohort (frequency of severe hypoglycaemia 0.12 events/year before and 0.0 after intervention). CONCLUSIONS: In people admitted for optimising insulin therapy or severe hypoglycaemia, metabolic control improved substantially and frequency of severe hypoglycaemia was significantly reduced after participation in a structured inpatient intervention. Reasons could be motivational and better adapted eating habits, tailoring individual therapy solutions and deescalating diabetes therapy in people after severe hypoglycaemia.

Association Between Glycaemic Control and the Intake of Thiazide Diuretics, Beta Blockers and Levothyroxine in People Without Diabetes.

OBJECTIVE: The pharmacological additional information for many medications includes warnings stating that the blood sugar control may be worsened by the intake of certain drugs. However a quantification of the effects is missing. This may result in confusion for patients as well as for their physicians. The aim of this study was to assess a potential association between medication (beta blockers, thiazides, levothyroxine) and HbA1c in people without diabetes. METHODS: In this cross-sectional study we analysed data from 2 921 people (7 699 visits) without diabetes (age 46.6 y; 69.1% women; BMI 27.6±6.4 kg/m²; HbA1c 5.2%) who had at least one HbA1c determination and a complete documentation of their drug intake. An oral glucose tolerance test was not performed. The participants were divided in 8 groups (no regular drug intake, levothyroxine alone, beta blockers alone, thiazides alone, combination 2 of 3, combination of all 3). Patients with known distorting influences of the HbA1c were excluded. RESULTS: People with no regular drug intake had an HbA1c of 5.4% [35.8 mmol/mol]. The HbA1c of the group that took all 3 drugs in combination was 5.6% [38.2 mmol/mol]. A multiple linear mixed model showed an increase in HbA1c for thiazides (ß=0.0558, p=0.025) and a decrease for combination of levothyroxine and thiazide (ß=-0.0765, p=0.010). CONCLUSION: Thiazides and the combination of levothyroxine and thiazides were associated with slight changes in HbA1c. In this study there was no association between the intake of beta blockers and HbA1c. At least for people without diabetes these effects seem to be of minor importance.

Association between Flash Glucose Monitoring and Metabolic Control as well as Treatment Satisfaction in Outpatients With Diabetes Type 1.

OBJECTIVE: The aim of this study was to follow-up people with diabetes type 1 and Flash Glucose Monitoring (FGM) regarding metabolic control and treatment satisfaction. METHODS: 40 people with diabetes type 1 and FGM use of ≥6 months were included in the study (female 55%, age 50.9 y, diabetes duration 21.9 y, HbA1c 7.4%, 57.6 mmol/mol, insulin pump therapy 32.5%). The number of scans per day and time/frequency of hypoglycaemia (interstitial glucose value ≤3.9 mmol/l) was recorded from 28 days of the glucose readings. Change of treatment satisfaction was assessed with the DTSQc questionnaire at follow-up (range-18 to+18). RESULTS: Mean time of follow-up was 1.0±0.4 y. At follow-up, all participants scanned interstitial glucose 11.9±7.7 times/day. Number of self-monitoring of blood glucose decreased from 6.7±4.2 (baseline) to 0.9±1.8 (follow-up) per day (p<0.001). In individuals with baseline HbA1c ≤7.5%, HbA1c increased (from 6.6±0.7% to 7.0±0.4%, p=0.020). On the contrary, in people with HbA1c>7.5%, HbA1c decreased (from 8.2±0.7% to 7.8±0.7%, p=0.001). In all participants, there were no differences regarding insulin dosage (33.8±12.9 vs. 34.6±13.9 IU/day, p=0.679) and number of insulin injections/day (3.9±2.3 vs. 4.0±2.6, p=0.813) between baseline and follow-up. Frequency of symptomatic hypoglycaemia was at baseline 0.3±0.3 events/day and 0.48±0.36 events/day (recognised, symptomatic events) at follow-up, respectively. In addition, 0.26±0.21 unrecognised hypoglycaemic events/day occurred at follow-up. Treatment satisfaction increased by+12.6 points. CONCLUSIONS: FGM was associated with an enormous increase in treatment satisfaction and slightly improved metabolic control in people with baseline HbA1c>7.5%. The number of capillary glucose measurements decreased significantly.

Successful Treatment with Bedtime Basal Insulin Added to Metformin without Weight Gain or Hypoglycaemia over Three Years.

The aim of this observational study was to follow-up patients with bedtime basal insulin (NPH insulin) added to metformin. In 285 patients with type 2 diabetes, a therapy with bedtime basal insulin added to metformin was started due to failure to achieve a glycaemic goal. Up until July 2019, 272 patients (95.4%) were followed-up (59.5 y, 92.6 kg, diabetes duration 6.6 y, HbA1c 8.4%/68.6 mmol/mol). HbA1c decreased by -1.2% and bodyweight by -1.7 kg after a duration of 31.7 ± 29.1 (range 2-133) months. Severe hypoglycaemia did not occur. In 144/272 patients (52.9%), the therapeutic goal for HbA1c was achieved over 32.7 months. In 69/272 patients (25.4%), the HbA1c target was achieved over 25.0 months (afterwards, therapy with basal insulin was discontinued because HbA1c was under target). In 36/272 patients (13.2%), the HbA1c goal was achieved until the submission of this manuscript (mean duration of treatment 57.4 ± 28.2 (range 13-121) months). Over 90% of patients with type 2 diabetes and failure of metformin reached their HbA1c goal with additional basal insulin at bedtime over several years in association with a reduction of bodyweight and without any event of severe hypoglycaemia.

Adequate Structured Inpatient Diabetes Intervention in People With Type 1 Diabetes Improves Metabolic Control and Frequency of Hypoglycaemia.

OBJECTIVE: Several studies evaluated inpatient diabetes teaching and treatment programmes (DTTP) in diabetes type 1 (DM1) many years ago, but in these studies insulin treatment was not yet intensified before the DTTP. Today, most patients are already on intensified insulin treatment before entering a DTTP. The aim of this trial was to evaluate the outcome one year after participation in an inpatient intervention including a DTTP in a longitudinal study. METHODS: 109 patients participated in an inpatient intervention in 2014. All individuals were invited to participate in an outpatient follow-up visit after one year. RESULTS: Ninety participants (52.2% female, age 48.0 y, diabetes duration 19.1 y, 31.1% CSII, HbA1c 7.9% / 63.3 mmol/mol) were followed-up after 1.2±0.3 y [1 died, 18 declined / were not available]. 83 / 90 individuals participated to optimise diabetes therapy, 7 / 90 had newly-diagnosed DM1. In the optimisation group, HbA1c decreased by 0.4% (p=0.009) without change of insulin dose (54 IU/day before and after) or BMI (26 kg/m2 before and after). In people with baseline HbA1c ≥7.5% (n=26 / 83), HbA1c decreased by 0.9%. The frequency of severe hypoglycaemia decreased from 0.22 to 0.05 events / year (p=0.045). In people with frequent non severe hypoglycaemia (n=8), events decreased from 4.5±2.0 to 2.8±0.9 / week (p=0.358). Systolic (-6.5 mmHg, p=0.035) and diastolic (-3.4 mmHg, p=0.003) blood pressure improved without change of number of antihypertensive medication (1.9±2.1 vs. 1.8±2.0, p=0.288). CONCLUSIONS: In people with DM1, metabolic control improved after the inpatient intervention without increasing insulin dosage or BMI. The inpatient intervention remains effective to substantially improve metabolic control under the present circumstances of care.

Overestimation of Risk and Increased Fear of Long-term Complications of Diabetes in People with Type 1 and 2 Diabetes.

OBJECTIVE: The quality report of the disease management programmes of North Rhine Westphalia 2016 showed prevalences for long-term complications (neuropathy, nephropathy, retinopathy) of less than 30% for people with diabetes type 1 (DM1) and type 2 (DM2). The aim of this study was to assess risk expectations and fear regarding long-term complications of diabetes in people with DM1 and DM2. METHODS: We assessed risk expectations and fear regarding diabetes complications in people with DM1 (n=110) and DM2 (n=143 without insulin, n=249 with insulin) visiting an University outpatient department of metabolic diseases. Fear of long-term complications was measured with the "Fear of Complications Questionnaire (FCQ)" (range 0-45 points, scores ≥30 suggest elevated fear). Participants were asked to estimate general and personal risks of long-term complications 10 years after developing diabetes in %. RESULTS: Elevated fear of complications (FCQ scores ≥30) was observed in 34.5, 25.9, and 43.0% of those with DM1, DM2 without insulin and DM2 with insulin, respectively. Participants estimated a mean general risk of diabetes-related complications after 10 years amounting to 45.9±15.8% (DM1), 49.7±15.4% (DM2 without insulin), and 52.5±16.4% (DM2 with insulin) and personal risk with 52.5±24.4% (DM1), 45.8±22.7% (DM2 without insulin), and 54.1±23.4% (DM2 with insulin), respectively. Higher risk expectations were associated with higher fear of complications (p<0.001). CONCLUSION: Risk estimations regarding long-term complications were exaggerated in people with DM1 and DM2. About one third of the participants reported elevated fear of complications. Participants' risk expectations and fear regarding diabetes complications appear excessive compared to population-based prevalence rates.

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.

Expectations and fear of diabetes-related long-term complications in people with type 2 diabetes at primary care level.

AIMS: The quality report of patients enrolled in the disease management programmes of North Rhine Westphalia 2016 showed prevalence of long-term complications in diabetes type 2: neuropathy 24.2%, nephropathy 12.5%, retinopathy 8.2%. The aim of this study was to assess expectations and fear of diabetes-related long-term complications in people with diabetes type 2. METHODS: We assessed expectations and fear of diabetes-related complications in 104 people with diabetes type 2 (age 67.0J, diabetes duration 6.6J, HbA1c 6.6%/48.6 mmol/mol, neuropathy 20.2%, nephropathy 11.5%, retinopathy 1.9%) in an outpatient healthcare centre at primary care level. Fear of diabetes-related complications was assessed using the "Fear of Complications Questionnaire" (FCQ) with a range of 0-45 points (≥ 30 means clinically meaningful fear, higher scores imply higher level of fear). Furthermore, study participants estimated general and personal risk of suffering from diabetes-related long-term complications after 10 years of diabetes duration on a scale of 0-100%. RESULTS: Mean FCQ score was 22.9 ± 11.5. 34/104 participants (32.7%) scored ≥ 30 points and thus had great fear. Participants estimated general risk of suffering from diabetes-related complications after 10 years of diabetes duration on 55.1% and personal risk on 46.0%. Risk of diabetes-related complications scoring highest was impaired circulation of lower limb (62.1%), eye complications (57.3%) and kidney complications (54.7%). CONCLUSION: Prevalence of diabetes-related long-term complications was overestimated in people with diabetes type 2. Approximately one third of the participants showed even great fear. Patient expectation and fear about diabetes-associated complications did not correspondent with data on clinical reality.

Informed shared decision-making programme for patients with type 2 diabetes in primary care: cluster randomised controlled trial.

OBJECTIVE: To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. DESIGN: Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data. SETTING: 22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes. PARTICIPANTS: 279 of 363 eligible patients without myocardial infarction or stroke. INTERVENTIONS: The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors. RESULTS: ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%. CONCLUSIONS: The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER: ISRCTN77300204; Results.

No selection, but higher satisfaction of people participating in the disease management programme diabetes type 2 in Germany.

AIMS: We analysed metabolic control, complications and satisfaction in people with and without DMP participation. METHODS: We retrospectively analysed the German data of the GUIDANCE study. The general practices included (n = 38) were selected from the physicians' register of the Thuringian Association of Statutory Health Insurance Physicians. Half of the practices (n = 19) participated in the DMP "Diabetes mellitus type 2". RESULTS: Nine hundred and fifty-nine people were included in the analysis. Of these, 541 (56.4%) were enrolled in the DMP and 418 (43.6%) not. There was no difference between the two groups (DMP vs. no DMP) regarding age (67.8 vs. 67.6y), gender (female 50.6 vs. 52.2%), diabetes duration (9.8 vs. 9.5y), BMI (31.3 vs. 30.7 kg/m2), HbA1c (7.2 vs. 7.2%), systolic blood pressure (139 vs. 140 mm Hg) or antihypertensive drug (89.5 vs. 88.8%). More DMP participants had regular screening of diabetic late complications: retinopathy 84.7 versus 69.9% (p < 0.001); polyneuropathy 93.0 versus 52.6% (p < 0.001). Chronic kidney disease was more frequent in DMP participants (15.0 vs. 9.3%, p = 0.005). Treatment satisfaction was higher in participants enrolled in the DMP (31.1 vs. 30.0; p = 0.002). CONCLUSIONS: DMP participants do not exhibit positive selection. Process quality and treatment satisfaction are higher in DMP participants.

Substantial improvement in HbA1c following a treatment and teaching programme for people with type 2 diabetes on conventional insulin therapy in an in- and outpatient setting.

AIMS: The aim of the study was to assess the efficacy of a patient education programme (DTTP) for the optimisation of conventional insulin therapy in patients with type 2 diabetes in an in- and outpatient setting. METHODS: The study was designed as a prospective, longitudinal trial. Thirty-three people with diabetes (females 54.5%, age 61.0 years, diabetes duration 12.7 years, HbA1c 9.3%) from ten general practices in Thuringia (outpatient group) participated in a DTTP for conventional insulin therapy. Thirty-three individuals-matched pairs-(female 72.7%, age 63.2 years, diabetes duration 13.6 years, HbA1c 9.7%) who were hospitalised for the optimisation of conventional insulin therapy participated in the same DTTP during their hospitalisation. All individuals were invited to participate in an outpatient follow-up visit 12 months after participation in the DTTP. RESULTS: All participants were re-examined after 1.0 ± 0.2 years. HbA1c improved in both groups equally by 1.2% in the outpatient group and 1.3% in the inpatient group. Insulin dosage increased marginally within the outpatient group (+ 0.09 units/kg/day, p = 0.023) and remained stable within the inpatients. Blood glucose self-monitoring increased significantly in both groups without inter-group difference (+ 7.9 vs. + 6.4 tests per week). CONCLUSION: Participation in an out- or inpatient DTTP improved substantially HbA1c levels in people with type 2 diabetes on conventional insulin treatment. Probably, the improved adjustment of the eating behaviour to the insulin therapy was the reason for improved metabolic control. Guidelines should recommend "refresher" programmes when metabolic control deteriorates before an intensification of blood glucose-lowering treatment.

Reduction of HbA1c and diabetes-related distress after intervention in a diabetes day care clinic in people with type 2 diabetes but not with type 1 diabetes.

OBJECTIVE: The aim of this prospective, longitudinal study was to assess diabetes-related distress in people with diabetes mellitus type 1 (DM1) and type 2 (DM2) treated for diabetes-related problems and to evaluate, whether distress by diabetes are reduced after intervention in a diabetes day care clinic (DDC). METHODS: Diabetes-related burden was assessed with the "Problem Area In Diabetes" (PAID) questionnaire before (T0), directly after (T1) and 6 months after intervention (T2) in the DDC in 72 people (18 DM1, 54 DM2) admitted with a diabetes-specific problem to a DDC in a University department for metabolic diseases. A PAID score of ≥40 was considered as high diabetes-related distress. RESULTS: The PAID score in people with DM1 was not significantly different between T0, T1 and T2. Furthermore, neither HbA1c nor insulin dose did change at T2. In participants with DM2, the PAID score decreased significantly from T0 to T1 (18.4±15.9 vs. 15.4+± 13.0, p=0.042) and preserved the benefit at T2 (15.0±13.3). In addition, there was a significant reduction in HbA1c (-1.2%, p<0.001) and body weight (-1.3 kg, p=0.038) between T0 and T2. Insulin dose per day was 15.0 IU/day lower at T1 (p=0.006) and 9.0 IU/day lower at T2 (p=0.212) in comparison to T0. CONCLUSIONS: Diabetes-related distress was reduced after a problem-oriented intervention in a DDC in people with DM2 but not with DM1. Although, all participants at tertiary care level had serious diabetes-specific problems before intervention, mean PAID score was far under the threshold of 40 points thus distress was low.