Effectiveness of educational and behavioural interventions for reducing fear of hypoglycaemia among adults with type 1 diabetes: Systematic review and meta-analyses.

AIMS: To summarize and critically appraise evidence regarding the effectiveness of educational and/or behavioural interventions in reducing fear of hypoglycaemia among adults with type 1 diabetes. METHODS: Systematic searches of medical and psychology databases were conducted. Risk-of-bias was assessed using the Joanna Briggs Institute Critical Appraisal Tools. Data were synthesized using random-effects meta-analyses for randomized controlled trials (RCTs) and narrative synthesis for observational studies. RESULTS: Five RCTs (N = 682) and seven observational studies (N = 1519) met the inclusion criteria, reporting on behavioural, structured education and cognitive-behavioural therapy (CBT) interventions. Most studies assessed fear of hypoglycaemia using the Hypoglycaemia Fear Survey Worry (HFS-W) and Behaviour (HFS-B) subscales. Mean fear of hypoglycaemia at baseline was relatively low across studies. Meta-analyses showed a significant effect of interventions on HFS-W (SMD = -0.17, p = 0.032) but not on HFS-B scores (SMD = -0.34, p = 0.113). Across RCTs, Blood Glucose Awareness Training (BGAT) had the largest effect on HFS-W and HFS-B scores, and one CBT-based program was as effective as BGAT in reducing HFS-B scores. Observational studies showed that Dose Adjustment for Normal Eating (DAFNE) was associated with significant fear of hypoglycaemia reductions. CONCLUSIONS: Current evidence suggests that educational and behavioural interventions can reduce fear of hypoglycaemia. However, no study to date has examined these interventions among people with high fear of hypoglycaemia.

RT-CGM in adults with type 1 diabetes improves both glycaemic and patient-reported outcomes, but independent of each other.

AIMS: To examine in adults with type 1 diabetes (a) the effect of initiation of real-time continuous glucose monitoring (RT-CGM) on glycaemic and patient-reported outcomes (PROs), and (b) factors related to clinically relevant improvements and sustained device use. METHODS: 60 persons initiating RT-CGM completed questionnaires at device start and six months later. Demographics and clinical characteristics including (dis)continuation up until July 31st 2018 were obtained from medical records. RESULTS: After six months, 54 adults were still using RT-CGM. Short-term discontinuation (10%) was mainly related to end of pregnancy (wish). Longer-term discontinuation in those with an initial non-pregnancy indication was related to changes in the medical condition and behavioural/psychological reasons. After six months, HbA1c, diabetes-specific worries and self-efficacy improved (range d = |0.4|-|0.8|), while hypoglycaemia rate or awareness and more general distress did not change. More suboptimal scores at baseline were related to meaningful improvements in HbA1c (≥10 mmol/mol; 0.9%) and PROs (≥0.5 SD). Changes in glycaemic variables and PROs were not related. CONCLUSIONS: People with more suboptimal HbA1c and PRO values appear to benefit most from RT-CGM. Given the lack of association between improvements in medical outcomes and PROs, both should be included in evaluations of RT-CGM therapy on an individual level.

Tolerance of clinical uncertainty by geriatric residents: a qualitative study.

CONTEXT: With the growing complexity in health care, clinical uncertainty increases, even more so in geriatrics. Intolerance of clinical uncertainty can result in stress, burnout and additional costs. This makes tolerance of clinical uncertainty a highly relevant skill to learn. This study investigated how residents cope with clinical uncertainty and explored options to improve their tolerance of it. METHODS: We interviewed nine residents from the geriatric department of a university medical center and analyzed the interviews conform template analysis using the 'integrative model of uncertainty tolerance'. RESULTS: All residents experienced clinical uncertainty regularly and emphasized it was a relevant topic. Residents described clinical uncertainty as both negative and positive, explaining it was difficult to deal with and could lead to stress, but it also kept them focused, challenged them and stimulated learning. While most of the reported topics fitted in the theoretical model, the model did not reflect the dynamics of clinical uncertainty and lacked its consequences outside the workplace. Residents mainly responded to clinical uncertainty by asking supervisors and peers to double-check their decisions concerning a patient. Residents indicated that they barely discussed their own emotions, cognitions or learning processes with peers or their supervisors. They would welcome the incorporation of clinical uncertainty as standard theme in patient supervision and educational meetings. CONCLUSION: Clinical uncertainty is not a problem of an insecure, failing resident, but an inherent part of caring for complex geriatric patients. Residents deserve to be trained in tolerance of clinical uncertainty to improve their well-being and care for geriatric patients.

Effect of Automated Bolus Calculation on Glucose Variability and Quality of Life in Patients With Type 1 Diabetes on CSII Treatment.

PURPOSE: Automated bolus calculation may benefit patients with poorly controlled type 1 diabetes who are relatively new to continuous subcutaneous insulin infusion (CSII). This study investigated the effect of automated bolus calculation on glucose variability, glucose control, and diabetes-related quality of life in patients with reasonably well-controlled type 1 diabetes, accustomed to treatment with CSII for several years. METHODS: This open-label, single-center study included 32 patients (mean age, 45.9 [15.1] years; 34% male; disease duration, 27.3 [12.9] years; glycosylated hemoglobin [HbA1c] level, 64.6 [12.5] mmol/mol [8.1% (1.1%)]; CSII treatment, 9.0 [7.8] years) who were randomly assigned to receive 4 months' treatment with a bolus calculator (n = 14) or continuation of standard care without a bolus calculator (n = 18). All participants received dietary counseling on carbohydrate counting. Primary outcome was glucose variability, as assessed by the SD of 7-point glucose profiles. Secondary outcomes included HbA1c, rate of (severe) hypoglycemia, and diabetes-related quality of life. FINDINGS: After 4 months of follow-up, glucose variability had improved in the bolus calculator group compared with the control group (change, -0.8 [0.9] vs 0.1 [0.9] mmol/L; P = 0.030). Mean glucose levels did not change in either group (0.4 [1.1] vs 0.3 [0.9] mmol/L; P = 0.95). There were also no differences in change in hypoglycemia rate (-0.6 [1.6] vs -0.4 [1.6] event per patient per week; P = 0.67), HbA1c value (-0.5 [6.6] vs -4.9 [10.6] mmol/mol; P = 0.21), or diabetes-related quality of life between the bolus calculator group and the control group. IMPLICATIONS: Use of a bolus calculator modestly improved glucose variability in this relatively small group of patients with longstanding type 1 diabetes on CSII but did not affect other parameters of glycemic control or diabetes-related quality of life.

A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial.

BACKGROUND: Fatigue is frequently reported by patients with type 1 diabetes mellitus. A recent study showed that 40 % of patients experienced severe fatigue that lasted for more than six months and was accompanied by substantial impairments in daily functioning. Currently, there is no effective treatment available for chronic fatigue in patients with type 1 diabetes. Cognitive behaviour therapy aimed at cognitions and behaviours that perpetuate fatigue is effective in reducing fatigue in other chronic diseases. Recent research showed that these cognitions and behaviours are also potential determinants of fatigue in type 1 diabetes. We designed Dia-Fit, a web-based cognitive behaviour therapy for severe and chronic fatigue in patients with type 1 diabetes. This patient-tailored intervention is aimed at reducing fatigue by changing cognitions and behaviours assumed to maintain fatigue. The efficacy of Dia-Fit will be investigated in this study. METHODS/DESIGN: A randomised controlled trial will be conducted in 120 patients with type 1 diabetes who are chronically and severely fatigued. Patients will be randomised to a treatment or waiting list group. The treatment group will receive Dia-Fit, a blended care therapy consisting of up to eight internet modules and face-to-face sessions with a therapist during a five-month period. The treatment will be tailored to the fatigue-maintaining cognitions and behaviours that are relevant for the patient and are determined at baseline. The waiting list group will receive Dia-Fit after a waiting period of five months. The primary outcome measure is fatigue severity. Secondary outcome measures are functional impairment and glucose control determined by haemoglobin A1c and blood glucose variability. DISCUSSION: To our knowledge, this is the first study investigating the efficacy of a cognitive behavioural intervention for chronic fatigue in patients with type 1 diabetes. TRIAL REGISTRATION: Dutch trial register NTR4312 (10 December 2013).

Chronic fatigue in type 1 diabetes: highly prevalent but not explained by hyperglycemia or glucose variability.

OBJECTIVE Fatigue is a classical symptom of hyperglycemia, but the relationship between chronic fatigue and diabetes has not been systematically studied. We investigated prevalence, impact, and potential determinants of chronic fatigue in patients with type 1 diabetes mellitus (T1DM). RESEARCH DESIGN AND METHODS Out of 324 randomly selected T1DM outpatients, 214 participated in this cross-sectional observational study. Participants were compared with age- and sex-matched population-based controls. Chronic fatigue, functional impairments, current health status, comorbidity, diabetes-related factors, and fatigue-related cognitions and behaviors were assessed with questionnaires, and HbA1c values and comorbidity were assessed with medical records. Sixty-six patients underwent continuous glucose monitoring combined with an electronic fatigue diary for 5 days. Acute fatigue and four glucose parameters were determined: mean, variability, and relative time spent in hypoglycemia and hyperglycemia. RESULTS T1DM patients were significantly more often chronically fatigued (40%; 95% CI 34-47%) compared with matched controls (7%; 95% CI 3-10%; P < 0.001). Chronically fatigued patients had significantly more functional impairments. Fatigue was the most troublesome symptom. Age, depression, pain, sleeping problems, low self-efficacy concerning fatigue, and physical inactivity were significantly associated with chronic fatigue. Chronically fatigued patients spent slightly less time in hypoglycemia (proportion 0.07 ± 0.06 vs. 0.12 ± 0.10; P = 0.025). Glucose parameters were not related to acute fatigue. CONCLUSIONS Chronic fatigue is highly prevalent and clinically relevant in T1DM. Its significant relationship with cognitive behavioral variables and weak association with blood glucose levels suggests that behavioral interventions could be helpful in managing chronic fatigue in T1DM.

Predicting fatigue in patients using home parenteral nutrition: a longitudinal study.

BACKGROUND: Home parenteral nutrition (HPN) is a life-saving therapy for patients with diseases that preclude adequate oral or enteral food intake. HPN has a large impact on daily life. Many patients suffer from fatigue and depression, and they experience limits in social activities. This all contributes to a lower quality of life. PURPOSE: Fatigue is the most frequently mentioned problem in Dutch HPN patients. Therefore, we studied the prevalence, course and predictors of fatigue in these patients. METHODS: Patients completed questionnaires at baseline and follow-up (12 months later). Measurements included fatigue, depression, functional impairment, social support, self-efficacy, coping, anxiety and acceptance. Laboratory measures, including total bilirubin, creatinine, albumin and haemoglobin levels, were obtained from the medical records. Descriptive statistics, correlations and linear regression analysis were performed. RESULTS: The response rate was 71% (n = 75). Sixty-five per cent of the patients were severely fatigued (n = 49). Eighty-nine per cent experienced persistent fatigue. Baseline fatigue predicted 57% of the variance of fatigue at follow-up, and avoidance was responsible for 3% of the variance. No significant correlations between fatigue and laboratory measures were found. A cross-sectional analysis showed that 46% of the variance of fatigue was explained by functional impairment, self-efficacy and depression. CONCLUSION: Severe fatigue is a persistent problem for HPN patients. Baseline fatigue was the strongest predictor of fatigue at follow-up. Functional impairment, self-efficacy and depression are strongly related to fatigue. Early recognition and treatment of fatigue are important.

Impact of a maximal exercise test on symptoms and activity in chronic fatigue syndrome.

OBJECTIVE: This study examined the effects of exercise on symptoms and activity in chronic fatigue syndrome (CFS). METHODS: Twenty CFS patients and 20 neighborhood controls performed an incremental exercise test until exhaustion. Fatigue, muscle pain, minutes spent resting, and the level of physical activity were assessed with a self-observation list. Physical activity was assessed with an actometer as well. Data were obtained 3 days before the maximal exercise test (MET) up to 5 days thereafter. RESULTS: For CFS patients, daily observed fatigue was increased up to 2 days after the exercise test. For controls, self-observed fatigue returned to baseline after 2 h. Both CFS patients and controls spent more minutes resting on the day before and on the day after the MET. For CFS patients, self-observed minutes resting increased on the day of the exercise test. For neither group, a decrease of actometer recorded or self-observed physical activity after exercise was found. CONCLUSION: Fatigue in CFS patients increased after exercise, but the level of actual physical activity remained unchanged.

Predictors of outcome in fatigued employees on sick leave: results from a randomised trial.

OBJECTIVE: The main objective of this study was to identify predictors of fatigue caseness, work resumption and chronic fatigue syndrome (CFS)-like caseness in a sample of fatigued employees on sick leave. METHODS: For 12 months, 151 fatigued employees on sick leave, 44% of whom met research criteria for CFS at baseline, were followed. Measures included fatigue, health aspects, psychological problems, burnout, causal attributions and self-efficacy. Logistic regression analysis was used to determine associations between predictor variables at baseline and outcome at follow-up. RESULTS: After 12 months, 43% of the patients were no longer fatigue cases, and 62% had resumed work. Recovery from fatigue caseness was predicted by stronger psychological attributions and other perception-related factors, whereas work resumption was predicted by lower age, male sex, CFS-like caseness and less cognitive difficulties. Lower physical functioning scores were predictive of (the development of) CFS-like caseness. CONCLUSION: Recovering from persistent fatigue and work resumption seem to result from different underlying processes and do not necessarily fall together. As many factors associated with outcome in fatigue reflect illness perception, the prevention of persistent fatigue and CFS may partly be achieved by the modification of perception.

Manual-based cognitive behaviour therapy for chronic fatigue syndrome: therapists' adherence and perceptions.

Several randomized controlled trials have indicated that cognitive behaviour therapy is an effective treatment for chronic fatigue syndrome. In 1 of these studies 13 therapists applied cognitive behaviour therapy for chronic fatigue syndrome in 83 chronic fatigue syndrome patients. In the present study therapists' adherence and perceptions of the manual are studied. Following completion of the study the therapists were asked to complete a questionnaire. Audiotaped sessions were conducted to verify the therapists' adherence. Analyses of the audiotapes showed that in 87% of the sessions this appeared to be the case. The questionnaire revealed that the therapists found it more difficult to treat patients with chronic fatigue syndrome than to treat patients with psychological or other physical problems. Treatment aspects posing the most problems were integrating individual problems into the standardized treatment, dealing with the patients' lack of confidence in the treatment and handling insufficient motivation.

An alternative trial design to overcome validity and recruitment problems in primary care research.

BACKGROUND: Although the randomized controlled trial is widely accepted as the best design to investigate new interventions, conducting a trial in primary care may present researchers with many methodological problems. OBJECTIVE: Our aim was to present an alternative trial design to overcome internal validity and recruitment problems. METHODS: In a randomized controlled trial, fatigued employees absent from work were selected among the population of an occupational health service in the South of The Netherlands. Patients randomly assigned to the experimental condition received cognitive behavioural therapy by a research GP near their home address, whereas patients in the control group received no intervention. We describe our considerations for building an alternative design. Research GPs and patients were recruited separately for the study. The pre-randomization design was applied. RESULTS: Nine research GPs performed all the interventions. Seventy-six experimental patients and 75 control patients were selected for study participation. Of these, only six patients in the experimental group and seven patients in the control group withdrew from the study at some point during follow-up. CONCLUSION: Results suggest that recruitment and randomization procedures in the alternative design served their purpose well. The alternative design proposed here might have several advantages compared with conventional trial procedures. However, our design is not widely applicable and there are ethical aspects involved that should be considered. Researchers should address their creativity when trying to minimize the problems they may encounter in designing a study.

Efficacy of cognitive-behavioural therapy by general practitioners for unexplained fatigue among employees: Randomised controlled trial.

BACKGROUND: Fatigue is a common complaint that may lead to long-term sick leave and work disability. AIMS: To assess the efficacy of cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue among employees. METHOD: A randomised controlled trial, using a pre-randomisation design in primary care, investigated 151 employees on sick leave with fatigue. Participants in the experimental group were offered five to seven 30 min sessions of cognitive-behavioural therapy by a general practitioner; those in the control group were offered no treatment. Main outcome measures (fatigue severity, self-reported absenteeism, registered absenteeism and clinical recovery) were assessed at 4 months, 8 months and 12 months. RESULTS: At baseline, 44% of the patients already met research criteria for chronic fatigue syndrome. There was no significant difference between the experimental group and the control group on primary or secondary outcomes at any point. CONCLUSIONS: Cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue did not prove to be an effective intervention. Since these doctors were unable to deliver this therapy effectively under ideal circumstances, it is unlikely that doctors in routine practice would be more successful in doing so.