Dominic Ehrmann

The effect of a diabetes education programme (PRIMAS) for people with type 1 diabetes: Results of a randomized trial

OBJECTIVE In a randomized, multi-centre trial, the efficacy of a self-management-oriented education programme (PRIMAS) for people with type 1 diabetes was compared with an established education programme as control group (CG). Primary outcome was the effect on glycaemic control in a 6-month follow-up. Secondary outcomes were the impact on emotional aspects, self-management related aspects and hypoglycaemia problems. METHODS The study was conducted in an outpatient setting. 160 participants were randomized. Baseline characteristics in PRIMAS and CG were similar (age 45.1±13.5 vs. 45.9±13.1 years, p=.716; diabetes duration 18.8±12.3 vs. 19.8±13.4 years, p=.615; BMI 26.5±4.6 vs. 27.5±5.0kg/m(2), p=.236; HbA1c 8.3±1.1 vs. 8.1±1.0%, p=.236). RESULTS At follow-up there was a significant 0.4 percentage points greater reduction of HbA1c in PRIMAS compared to CG (Δ -0.4±1.0% vs. Δ 0.0±0.6%; p=.012). Also, diabetes-related distress (Δ -0.3±0.7 vs. -0.1±0.4, p=.032) and dissatisfaction with diabetes treatment (Δ -3.3±6.9 vs. -1.9±5.6, p=.024) decreased more in PRIMAS. Diabetes empowerment (Δ 2.6±5.9 vs. 0.8±5.1, p=.037) and diabetes self-efficacy (Δ 1.4±3.6 vs. 0.2±4.0, p=.013) increased in PRIMAS. Incidence of severe hypoglycemia, hypoglycemia awareness, diabetes knowledge, and self-care behaviour improved in both groups with no significant differences between groups. CONCLUSION PRIMAS is more effective in lowering HbA1c than a previously established education programmes and also showed superiority in reducing diabetes-related distress and increasing diabetes empowerment, diabetes self-efficacy and satisfaction with insulin therapy.

Real-time continuous glucose monitoring in adults with type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial

BACKGROUND The effectiveness of real-time continuous glucose monitoring (rtCGM) in avoidance of hypoglycaemia among high-risk individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) is unknown. We aimed to ascertain whether the incidence and severity of hypoglycaemia can be reduced through use of rtCGM in these individuals. METHODS The HypoDE study was a 6-month, multicentre, open-label, parallel, randomised controlled trial done at 12 diabetes practices in Germany. Eligible participants had type 1 diabetes and a history of impaired hypoglycaemia awareness or severe hypoglycaemia during the previous year. All participants wore a masked rtCGM system for 28 days and were then randomly assigned to 26 weeks of unmasked rtCGM (Dexcom G5 Mobile system) or to the control group (continuing with self-monitoring of blood glucose). Block randomisation with 1:1 allocation was done centrally, with the study site as the stratifying variable. Masking of participants and study sites was not possible. Control participants wore a masked rtCGM system during the follow-up phase (weeks 22-26). The primary outcome was the baseline-adjusted number of hypoglycaemic events (defined as glucose ≤3·0 mmol/L for ≥20 min) during the follow-up phase. The full dataset analysis comprised participants who wore the rtCGM system during the baseline and follow-up phases. The intention-to-treat analysis comprised all randomised participants. This trial is registered with ClinicalTrials.gov, number NCT02671968. FINDINGS Between March 4, 2016, and Jan 12, 2017, 149 participants were randomly assigned (n=74 to the control group; n=75 to the rtCGM group) and 141 completed the follow-up phase (n=66 in the control group, n=75 in the rtCGM group). The mean number of hypoglycaemic events per 28 days among participants in the rtCGM group was reduced from 10·8 (SD 10·0) to 3·5 (4·7); reductions among control participants were negligible (from 14·4 [12·4] to 13·7 [11·6]). Incidence of hypoglycaemic events decreased by 72% for participants in the rtCGM group (incidence rate ratio 0·28 [95% CI 0·20-0·39], p<0·0001). 18 serious adverse events were reported: seven in the control group, ten in the rtCGM group, and one before randomisation. No event was considered to be related to the investigational device. INTERPRETATION Usage of rtCGM reduced the number of hypoglycaemic events in individuals with type 1 diabetes treated by MDI and with impaired hypoglycaemia awareness or severe hypoglycaemia. FUNDING Dexcom Inc.

Depression is linked to hyperglycaemia via suboptimal diabetes self-management: A cross-sectional mediation analysis

OBJECTIVE To analyse if the association between depressive symptoms and hyperglycaemia is mediated by diabetes self-management. METHODS 430 people with diabetes (57.7% type 1, 42.3% type 2) were cross-sectionally assessed using validated self-report scales for depressive symptoms (Center for Epidemiologic Studies Depression Scale (CES-D)) and diabetes self-management (Diabetes Self-Management Questionnaire (DSMQ)); HbA1c was analysed simultaneously in a central laboratory. Structural equation modelling was used to test if the association between depressive symptoms and hyperglycaemia (HbA1c) was mediated by suboptimal self-management in people with type 1 and type 2 diabetes. RESULTS The hypothesised model of depressive symptoms, diabetes self-management and hyperglycaemia fit the data well for both diabetes types (SRMR≤0.04, TLI≥0.99, CFI>0.99, RMSEA≤0.02 for both models). In both the type 1 and type 2 diabetes group, higher depressive symptoms were associated with lower self-management (P<0.001) and lower self-management was associated with higher HbA1c (P<0.001). Results indicated that the association between depressive symptoms and hyperglycaemia was significantly mediated by suboptimal diabetes self-management in both type 1 and type 2 diabetes patients (P<0.001). Significant direct associations between depressive symptoms and hyperglycaemia, not mediated by self-management, could not be observed. CONCLUSIONS This study provides good evidence supporting that depression is linked to hyperglycaemia via suboptimal diabetes self-management in both major diabetes types.

Assessing Diabetes Self-Management with the Diabetes Self-Management Questionnaire (DSMQ) Can Help Analyse Behavioural Problems Related to Reduced Glycaemic Control

Aim To appraise the Diabetes Self-Management Questionnaire (DSMQ)’s measurement of diabetes self-management as a statistical predictor of glycaemic control relative to the widely used SDSCA. Methods 248 patients with type 1 diabetes and 182 patients with type 2 diabetes were cross-sectionally assessed using the two self-report measures of diabetes self-management DSMQ and SDSCA; the scales were used as competing predictors of HbA1c. We developed a structural equation model of self-management as measured by the DSMQ and analysed the amount of variation explained in HbA1c; an analogue model was developed for the SDSCA. Results The structural equation models of self-management and glycaemic control showed very good fit to the data. The DSMQ’s measurement of self-management showed associations with HbA1c of –0.53 for type 1 and –0.46 for type 2 diabetes (both P < 0.001), explaining 21% and 28% of variation in glycaemic control, respectively. The SDSCA’s measurement showed associations with HbA1c of –0.14 (P = 0.030) for type 1 and –0.31 (P = 0.003) for type 2 diabetes, explaining 2% and 10% of glycaemic variation. Predictive power for glycaemic control was significantly higher for the DSMQ (P < 0.001). Conclusions This study supports the DSMQ as the preferred tool when analysing self-reported behavioural problems related to reduced glycaemic control. The scale may be useful for clinical assessments of patients with suboptimal diabetes outcomes or research on factors affecting associations between self-management behaviours and glycaemic control.

Reduction of diabetes-related distress predicts improved depressive symptoms: A secondary analysis of the DIAMOS study

Objective Depressive symptoms in people with diabetes are associated with increased risk of adverse outcomes. Although successful psychosocial treatment options are available, little is known about factors that facilitate treatment response for depression in diabetes. This prospective study aims to examine the impact of known risk factors on improvement of depressive symptoms with a special interest in the role of diabetes-related distress. Methods 181 people with diabetes participated in a randomized controlled trial. Diabetes-related distress was assessed using the Problem Areas In Diabetes (PAID) scale; depressive symptoms were assessed using the Center for Epidemiologic Studies Depression (CES-D) scale. Multiple logistic and linear regression analyses were used to assess associations between risk factors for depression (independent variables) and improvement of depressive symptoms (dependent variable). Reliable change indices were established as criteria of meaningful reductions in diabetes distress and depressive symptoms. Results A reliable reduction of diabetes-related distress (15.43 points in the PAID) was significantly associated with fourfold increased odds for reliable improvement of depressive symptoms (OR = 4.25, 95% CI: 2.05–8.79; P<0.001). This result was corroborated using continuous measures of diabetes distress and depressive symptoms, showing that greater reduction of diabetes-related distress independently predicted greater improvement in depressive symptoms (ß = -0.40; P<0.001). Higher age had a positive (Odds Ratio = 2.04, 95% CI: 1.21–3.43; P<0.01) and type 2 diabetes had a negative effect on the meaningful reduction of depressive symptoms (Odds Ratio = 0.12, 95% CI: 0.04–0.35; P<0.001). Conclusions The reduction of diabetes distress is a statistical predictor of improvement of depressive symptoms. Diabetes patients with comorbid depressive symptomatology might benefit from treatments to reduce diabetes-related distress.

Reduction of depressive symptoms predicts improved glycaemic control: Secondary results from the DIAMOS study

AIMS Evidence from randomised trials analysing effects of depression treatment on glycaemic control in group comparisons is inconsistent. The aim of this study was to test if the reduction of depressive symptoms would explain improved glycaemic control irrespective of treatment groups. METHODS The DIAMOS study tested effects of cognitive-behavioural therapy (CBT) versus usual care on depressive symptoms in a 12-month prospective trial; HbA1c was a secondary outcome. Since the results suggested superiority of CBT for improving depressive symptoms, but not HbA1c, we conducted this secondary analysis to test if reduction of depressive symptoms could explain improved glycaemic control when assessed irrespective of treatment group affiliation. Reduction of depressive symptoms was assessed using baseline-to-follow-up changes in the Center for Epidemiologic Studies Depression Scale (CES-D). We used multiple regression analyses, adjusting for baseline HbA1c and depression, group affiliation and covariates, to assess associations between reduction of depressive symptoms and follow-up HbA1c. RESULTS 181 participants provided eligible data. Depressive symptoms decreased between baseline and follow-up by averagely -5.1±11.8 CES-D points. Greater reduction of depressive symptoms predicted greater improvement of HbA1c at follow-up, while adjusting for baseline HbA1c and covariates (Beta=-0.24, P=0.004). Additionally, patients with greater reduction of depressive symptoms were more likely to reach in-target HbA1c (<7.5%) at follow-up (adjusted OR=1.04, 95% CI 1.01-1.08, P=0.023). CONCLUSIONS The findings suggest that reduction of depressive symptoms can explain improved glycaemic control. Behavioural treatments might aim to improve both affective and glycaemic outcomes.

Comparison of the Efficacy of a Diabetes Education Programme for Type 1 Diabetes (PRIMAS) in a Randomised Controlled Trial Setting and the Effectiveness in a Routine Care Setting: Results of a Comparative Effectiveness Study.

Background The effectiveness of an intervention in clinical practice is often reduced compared to the efficacy demonstrated in a randomised controlled trial (RCT). In this comparative effectiveness study, the RCT-proven efficacy of a diabetes education programme for type 1 diabetic patients (PRIMAS) was compared to the effectiveness observed in an implementation trial (IT) under routine care conditions. Methods 75 patients with type 1 diabetes received PRIMAS through an RCT, whereas 179 patients were observed in an implementation trial. Baseline characteristics and treatment outcomes at the 6-month follow-up (improvement of HbA1c, hypoglycaemia problems, and diabetes-related distress) were compared. Results At baseline, the type 1 diabetic patients in the RCT had a significant longer diabetes duration (18.7±12.3 vs. 13.8±12.7 yrs., p = .005), lower self-efficacy scores (21.9±4.7 vs. 23.7±6.1, p = .02) and a greater number of diabetes complications (0.8±1.3 vs. 0.4±0.9, p = .02). After 6 months, PRIMAS achieved comparable effects under RCT and implementation trial conditions, as demonstrated by improvement in HbA1c (-0.36%±1.1 vs. -0.37±1.2; Δ -0.01, 95% CI -0.33 to 0.31) and hypoglycaemia unawareness (-0.5±1.4 vs. -0.3±1.4; Δ 0.18, 95% CI -0.21 to 0.57). The likelihood of clinical improvement did not depend on the trial setting (RCT vs. IT: OR 1.18, 95% CI 0.60 to 2.33). The participants with worse glycaemic control (OR 1.40, 95% CI 1.02 to 1.92), hypoglycaemia problems (OR 2.13, 95% CI 1.53 to 2.97) or elevated diabetes distress (OR 1.40, 95% CI 1.03 to 1.89) had a better chance of clinical improvement. Conclusions The effectiveness of PRIMAS under routine care conditions was comparable to the efficacy demonstrated in the RCT. Clinical improvement was independent of the setting in which PRIMAS was evaluated. The PRIMAS education programme for type 1 diabetes can be delivered under conditions of routine care without a loss of effectiveness, compared to its original evaluation in an RCT.

How Much Accuracy of Interstitial Glucose Measurement Is Enough? Is There a Need for New Evidence?

This analytical comment discusses what standards are needed for the evaluation of the accuracy of glucose measurement systems continuously measuring glucose in the interstitial fluid. Since accuracy standards for continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) systems are currently based on modeling studies or consensus of experts, we raised the question whether non-inferiority trials evaluating the safety and efficacy of CGM/FGM measurements compared to capillary blood glucose measurement with point-of-care devices could help to establish clarity about the needed accuracy standards of CGM/FGM. Such trials could also support the replacement of capillary blood glucose measurements by modern CGM/FGM systems.

Development of a New Tool to Assess Bolus Calculation and Carbohydrate Estimation

BACKGROUND Carbohydrate estimation and bolus calculation are two important skills for handling intensive insulin therapy and effectively using bolus calculators. Structured assessment of both skills is lacking. A new tool for the assessment of skills in carbohydrate estimation and bolus calculation was developed and evaluated. MATERIALS AND METHODS A new assessment tool (SMART) was developed that included 10 items for bolus calculation and 12 items for carbohydrate estimation. In total, 411 patients on intensive insulin treatment were recruited. Different parameters of glycemic control were used as validity criteria. RESULTS The SMART tool achieved good reliability for the assessment of bolus calculation (Cronbachs α = 0.78) and sufficient reliability for the assessment of carbohydrate estimation (Cronbachs α = 0.67). A good bolus calculation skill was significantly associated with lower glycated hemoglobin values (r = -0.27), lower mean blood glucose levels (r = -0.29), and higher fluctuation of blood glucose control (r = -0.43). A good carbohydrate estimation skill was significantly associated with a lower frequency of severe hyperglycemia (r = -0.27) and a higher frequency of euglycemia (r = 0.26). CONCLUSIONS SMART is a reliable and valid tool for the assessment of both skills. Bolus calculation as well as carbohydrate estimation was associated with glycemic control. With the help of SMART, important skills for the management of intensive insulin therapy can be assessed separately. Thus, in clinical practice patients in need of assistance from a bolus calculator can be identified.

Adherence Over Time: The Course of Adherence to Customized Diabetic Insoles as Objectively Assessed by a Temperature Sensor

Background: Temperature sensors are an objective way to assess adherence to diabetic footwear. Good adherence is essential for the prevention of diabetic foot problems. Little is known about the long-term course of adherence in patients at risk for diabetic foot problems. Method: A temperature sensor was incorporated into the specialized footwear of patients with type 2 diabetes after their first plantar ulceration. Kaplan-Meier curve was used to analyze when patients started to become nonadherent (not wearing the footwear for two straight weeks). Gender effects on adherence were also analyzed. Results: 26 patients with a mean observation time of 133.5 days could be analyzed. Mean wearing time of diabetic footwear was 4.2 ± 3.6 h/day (Mdn = 3.4 h/day; interquartile range = 0.5-7.0 h/day) and on 51% of the days patients did not wear their footwear at all. Kaplan-Meier curve revealed that the mean time of adherence was 27.5 weeks. Men achieved a mean time of adherence of 30.5 weeks, while women only achieved 14 weeks. However, due to the small sample size, this difference was not statistically significant. Conclusions: Temperature sensors revealed a low long-term adherence to diabetic footwear. Women seemed to be at a higher risk for earlier nonadherent behavior. Adherence to diabetic footwear should be closely monitored and tailored intervention strategies should be developed.