Diabetes distress and diabetes burnout explored in various areas of life in patients with type 1 diabetes: effect of short-term psychological intervention.

INTRODUCTION: Diabetes distress (DD) and diabetes burnout (DB) are recognized psychological phenomena in patients with T1DM (type 1 diabetes mellitus). Still, there is an urgent need to create professional psychological intervention procedures to provide patients with adequate care. AIM: The aim of the study was to assess the level of DD and DB in T1DM patients at baseline and after 5 of sessions psychological intervention in the group of participants who applied for help. METHODS: 34 T1DM patients who requested psychological support (22 females, 12 males) and 30 patients in a control group (14 females, 16 males) participated in the study. At baseline clinical test results between groups were compared. Next, in the studied group measurements were repeated after a set of five psychological face-to-face individual interventions which lasted 30-60 min each. They were support sessions with elements of cognitive-behavioral interventions done by clinical psychologists. Session 1: introduction, interview and collection of test results; session 2-4: work on the indicated by the patient and test results most problematic aspect of diabetes, session 5: a summary and plan for further treatment if needed. The control group results were obtained only at baseline. Research tools: DDS; PAID, Diabetes Burnout test by Polonsky. RESULTS: At the baseline, significant differences were observed between the studied group and control group: in DB/DD levels: DB (3.9 ± 1.7 vs 2.4 ± 1.6; p < 0.001); DDS (3.2 ± 1.0 vs 2.7 ± 1.0; p = 0.064); PAID (62.3 ± 14.1vs 34.4 ± 21.0; p < 0.001). There were also group differences in HbA1c levels (8.7 ± 2.4 vs 7.3 ± 1.5; p = 0.028). After psychological interventions, there was a significant improvement in DB (3.9 ± 1.7vs 2.9 ± 1.2; p < 0.001; DDS (3.2 ± 1 vs 3.0 ± 0.7; p = 0.03); PAID (62.3 ± 14.1 vs 51.8 ± 12.5; p < 0.001). CONCLUSIONS: DD and DB constitute a significant problem in the group of T1DM patients, but providing appropriate specialist care may help them accept diabetes and improve life satisfaction, as well as regain control over their diabetes management.

Lack of major impact of implementation of the Advanced Hybrid Closed Loop System in technologically-naïve patients with Type 1 Diabetes mellitus on their food choices or weight - a one year follow-up.

INTRODUCTION AND OBJECTIVE: The purpose of this follow-up study on the implementation of advanced closed-loop hybrid insulin pumps in people with type 1 diabetes was to assess the impact of introducing this advanced technology on quantitative and qualitative parameters of diet. MATERIAL AND METHODS: 18 patients (8 women and 10 men, mean age 40.9 years) patients using the CE-marked MiniMed 780G AHCL system who completed 1 year of follow-up were included into the study. The research tool was the KomPAN questionnaire with several own questions added, asked in three study periods, concerning the number of meals consumed, general and night snacking, carbohydrate counting, frequency of consumption of various groups of products that affect postprandial glycaemia. RESULTS: Although the mean body weight of the examined group did not increase significantly (from 75.1 kg at the beginning to 75,9 kg at the end), five various individual scenarios of weight change were observed. The eating habits has not changed, but patients began to consume less products containing simple sugars, e.g. fruit preserves, milk chocolate or fish in sauces (p<0.05). No statistically significant correlation was found between the change in body weight at the end of the study and the average amount of carbohydrates entered into the pump from the entire 12 months (p = 0.460). CONCLUSIONS: The implementation of AHCL system in technology naïve patients, despite offering more freedom of food choices due to better glycaemic control, did not have a significant impact on patients' dietary patterns, also did not result in weight gain. This is important since AHCL system offers more freedom of food choices due to better glycaemic control. However, the longer follow up and the study based on larger population is required to finally address the issue of the impact of AHCL on body mass.

Quality of life in the course of a one-year use of an advanced hybrid closed-loop system in adults with type 1 diabetes previously naïve to advanced diabetes technology.

Aim: To evaluate the effect of a one-year use of an advanced hybrid closed-loop (AHCL) system on the quality of life, level of anxiety, and level of self-efficacy in adults with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI) and naïve to advanced diabetes technology. Methods: A total of 18 participants of a previously published 3-month randomized trial (10 men, 8 women; age 40.9 ± 7.6 years) who were switched directly from MDI/BMG to AHCL completed 12 months of MiniMed 780G™system use (a 3-month randomized trial followed by a 9-month follow-up phase). At month 6 of the study, patients were switched from the sensor GS3 (Continuous Glucose Monitoring) system, powered by Guardian™ Sensor 3) to GS4. Quality of life was assessed using the Polish validated version of the 'QoL-Q Diabetes' questionnaire. The level of anxiety was evaluated with the use of the State-Trait Anxiety Inventory (STAI). Self-efficacy was assessed with the General Self-Efficacy Scale (GSES). Results were obtained at baseline and at the end of the study. Results: Significant increase in QoL was reported in the global score (p=0.02, Cohen d=0.61) and in as many as 11 out of 23 analyzed areas of life: being physically active (p=0.02, Cohen d = 0.71); feeling well (p<.01, Cohen d = 0.73); feeling in control of my body (p<.01, Cohen d = 0.72); looking good (p<.01, Cohen d = 1.07); working (p<.01, Cohen d = 1.12); sleeping (p=0.01, Cohen d = 0.66); eating as I would like (p<.01, Cohen d = 0.79); looking after or being useful to others (p= 0.02, Cohen d = 0.65); being active with pets/animals (p<.01, Cohen d = 0.95); being spontaneous (p=0.02, Cohen d = 0.67); and doing "normal" things (p=0.02, Cohen d = 0.67). Both state (p=0.04, Cohen d = 0.56) and trait (p=0.02, Cohen d = 0.60) anxiety decreased while the general self-efficacy increased (p=0.03, Cohen d = 0.76). No participant stopped the use of the pump. Conclusion: Adult patients with T1D previously treated with MDI and naïve to modern technologies experienced significant improvement in their psychological well-being after transitioning to the AHCL system after 12 months of treatment.

Identification of Sociodemographic and Clinical Factors Influencing the Feeling of Stigmatization in People with Type 1 Diabetes.

BACKGROUND: A large percentage of people with type 1 diabetes experience stigma, which may directly affect diabetes management. Moreover, it may adversely influence the acceptance of the disease and, thus, the treatment process, including compliance with medical and dietary recommendations. Therefore, it is important to seek adequate forms of counteracting the phenomenon of stigmatization. Thus, the aim of the study was to determine the factors influencing the level of perceived stigma by T1D patients, with particular emphasis on sociodemographic factors (including sex, place of residence, and education) and clinical factors related to the course of the disease. METHODS: An observational cross-sectional online questionnaire was conducted in a group of 339 people with T1D. The link to the questionnaire was shared via social media. The DSAS-1 questionnaire translated into Polish was used as the research tool. RESULTS: A moderate level of stigmatization was found (49.78 ± 14.54 points). It was significantly lower in people living in small towns compared to rural residents (ß = -0.121, p = 0.038), lower in people in relationships compared to those who are single (ß = -0.175, p = 0.001), in people diagnosed with T1D at an older age (ß = -0.107, p = 0.048), and in those who rated their financial situation as very good vs. bad (ß = -0.314, p < 0.001). It was also found that the level of stigma significantly decreased with age (ß = -0.181, p = 0.001). In addition, a significantly higher stigma perception was uncovered in the group of people with HbA1C > 7% than in the group ≤ 7% (ß = 0.118, p = 0.030). CONCLUSIONS: Due to the occurrence of stigma among people with T1D, which can directly affect the management of diabetes, effective and comprehensive efforts should be made to provide support to people with diabetes. It is also necessary to raise awareness among the general public and disseminate knowledge about diabetes, which can reduce stigmatization as a result. Anti-stigma messages should be included in the prevention programs about the potential side effects and risks associated with mistreating people with T1D.

Assessment of selected muscle damage markers and zonulin concentration after maximum-intensity exercise in men with type 1 diabetes treated with a personal insulin pump.

AIM: Exercise-induced muscle damage depends on exercise intensity and duration and on individual susceptibility. Mechanical and metabolic stress may disturb the intestinal microflora. The study evaluated selected muscle damage markers and zonulin concentration after maximum-intensity exercise in type 1 diabetes (T1D) men compared with healthy controls. METHODS: The study involved 16 T1D participants and 28 controls matched by age (22.7 [21.3-25.1] vs. 22.6 [20.9-26.3] years), body mass index (24.2 ± 1.6 vs. 24.2 ± 1.9 kg/m2), and body fat percentage (16.1 ± 5.2 vs. 14.9 ± 4.6%). The T1D group had 11.3 ± 5.1 years of diabetes duration and a suboptimal mean glycated haemoglobin level of 7.2 ± 1.1%. The subjects underwent a graded running treadmill test until exhaustion. Lactate concentration was assessed in arterialized blood at baseline and 3 and 20 min after the test. Cortisol, testosterone, tumour necrosis factor α, myoglobin, lactate dehydrogenase, zonulin, and vitamin D levels were evaluated in cubital fossa vein blood before and 60 min after the test. RESULTS: T1D patients presented higher baseline zonulin, myoglobin concentration, testosterone/cortisol ratio, and lower maximal oxygen uptake. On adjusting for the baseline values, the groups differed in zonulin, lactate dehydrogenase, and myoglobin levels, testosterone/cortisol ratio, and lactate concentration determined 20 min after exercise (P < 0.05). CONCLUSION: Maximum-intensity exercise increased muscle and intestinal damage in T1D participants. In patients with lower physical activity, very-high-intensity exercise should be recommended with caution. Observing the anabolic-catabolic index may help individualize effort intensity in T1D individuals.

Evaluation of Psychological Resources of Young Adults With Type 1 Diabetes Mellitus During the Transition From Pediatric to Adult Diabetes Clinics: Multicenter Cross-sectional Study.

BACKGROUND: The transition period of patients with type 1 diabetes from pediatric to adult-oriented health care is associated with poorer glycemic control and less frequent clinic attendance. Fears and anxiety about the unknown, care approach differences in adult settings, and sadness about leaving the pediatric provider all contribute to a patient's reluctance to transition. OBJECTIVE: This study aimed to evaluate the psychological parameters of young patients with type 1 diabetes transitioning to an adult outpatient clinic during the first visit. METHODS: We examined 50 consecutive patients (n=28, 56% female) transitioning from March 2, 2021, to November 21, 2022, into adult care (3 diabetes centers from 3 regions in southern Poland: A, n=16; B, n=21; and C, n=13) and their basic demographic information. They completed the following psychological questionnaires: State-Trait Anxiety Inventory (STAI), Generalized Self-Efficacy Scale, Perceived Stress Scale, Satisfaction with Life Scale, Acceptance of Illness Scale, Multidimensional Health Locus of Control Scale Form C, Courtauld Emotional Control Scale, and Quality of Life Questionnaire Diabetes. We compared their data with those for the general healthy population and patients with diabetes from Polish Test Laboratory validation studies. RESULTS: During the first adult outpatient visit, patients' mean age was 19.2 (SD 1.4) years, with a diabetes duration of 9.8 (SD 4.3) years and BMI of 23.5 (SD 3.1) kg/m2. Patients came from diverse socioeconomic backgrounds: 36% (n=18) live in villages, 26% (n=13) live in towns with ≤100,000 inhabitants, and 38% (n=19) live in bigger cities. Regarding therapy type, 68% (n=34) were treated with insulin pump therapy, whereas 32% (n=16) were treated with multiple daily injections. Patients from center A had a mean glycated hemoglobin level of 7.5% (SD 1.2%). There was no difference regarding the level of life satisfaction, perceived level of stress, and state anxiety between the patients and reference populations. Patients had similar health locus of control and negative emotions control to the general population of patients with diabetes. Most patients (n=31, 62%) believe that control over their health depends on themselves, whereas 52% (n=26) believe that it depends mostly on others. Patients had higher levels of suppression of negative emotions-anger, depression, and anxiety-than the age-matched general population. Additionally, the patients were characterized by a higher acceptance of illness and higher level of self-efficacy compared to the reference populations: 64% (n=32) had a high level of self-efficacy and 26% (n=13) had a high level of life satisfaction. CONCLUSIONS: This study indicated that young patients transitioning to adult outpatient clinics have good psychological resources and coping mechanisms, which might result in adequate adaptation and adult life satisfaction including future metabolic control. These result also disprove the stereotypes that young people with chronic disease have worse life perspectives when entering adulthood.

One-Year Follow-Up of Advanced Hybrid Closed-Loop System in Adults with Type 1 Diabetes Previously Naive to Diabetes Technology: The Effect of Switching to a Calibration-Free Sensor.

The aim of this study was to observe the 1-year clinical outcomes of people with type 1 diabetes who switched from multiple daily injection + blood glucose meter to an advanced hybrid closed-loop (AHCL) system (Medtronic MiniMed™ 780G system [MM 780G]). In addition, the effect of changing at month 6 to a calibration-free sensor (Guardian™ 4 Sensor [G4S]) was evaluated. Eighteen participants (10 men, age 40.9 ± 7.6 years) completed 1 year of MM 780G use. Time in range (TIR; 70-180 mg/dL) remained stable and ranged from 83.2% in month 9 to 84.8% in month 3. There was no difference between TIR at 3 months before switching versus 3 months after switching to G4S (P = 0.614). AHCL system in adults significantly improves glycemic outcomes. This improved glycemic control was maintained over the 12 months. Switching to a calibration-free sensor (G4S) did not affect outcomes but required less patient involvement.

Characteristics, Mortality, and Clinical Outcomes of Hospitalized Patients with COVID-19 and Diabetes: A Reference Single-Center Cohort Study from Poland.

Background: Diabetes is a risk factor for a severe course of COVID-19. We evaluated the characteristics and risk factors associated with undesirable outcomes in diabetic patients (DPs) hospitalized due to COVID-19. Materials and Methods: The data analysis of patients admitted between March 6, 2020, and May 31, 2021, to the University Hospital in Krakow (Poland), a reference center for COVID-19, was performed. The data were gathered from their medical records. Results: A total number of 5191 patients were included, of which 2348 (45.2%) were women. The patients were at the median age of 64 (IQR: 51-74) years, and 1364 (26.3%) were DPs. DPs, compared to nondiabetics, were older (median age: 70 years, IQR: 62-77 vs. 62, IQR: 47-72, and p < 0.001) and had a similar gender distribution. The DP group had a higher mortality rate (26.2% vs. 15.7%, p < 0.001) and longer hospital stays (median: 15 days, IQR: 10-24 vs. 13, IQR: 9-20, and p < 0.001). DPs were admitted to the ICU more frequently (15.7% vs. 11.0%, p < 0.001) and required mechanical ventilation more often (15.5% vs. 11.3%, p < 0.001). In a multivariate logistic regression, factors associated with a higher risk of death were age >65 years, glycaemia >10 mmol/L, CRP and D-dimer level, prehospital insulin and loop diuretic use, presence of heart failure, and chronic kidney disease. Factors contributing to lower mortality were in-hospital use of statin, thiazide diuretic, and calcium channel blocker. Conclusion: In this large COVID-19 cohort, DPs constituted more than a quarter of hospitalized patients. The risk of death and other outcomes compared to nondiabetics was higher in this group. We identified a number of clinical, laboratory, and therapeutic variables associated with the risk of hospital death in DPs.

Improvement of Selected Psychological Parameters and Quality of Life of Patients With Type 1 Diabetes Mellitus Undergoing Transition From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to the MiniMed 780G Advanced Hybrid Closed-Loop System: Post hoc Analysis of a Randomized Control Study.

BACKGROUND: While introducing new technologies and methods of treatment for type 1 diabetes mellitus (T1DM), it seems essential to monitor whether modern technologies in diabetes treatment may improve the psychological and emotional status of patients. OBJECTIVE: This study aims to assess the baseline psychological parameters of patients with T1DM during investigation of the direct transition from multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG) to the MiniMed 780G advanced hybrid closed-loop (AHCL) system and to evaluate changes in the psychological well-being and quality of life (QoL) after the transition in these individuals versus the control group. METHODS: The trial was a 2-center, randomized controlled, parallel group study. In total, 41 patients with T1DM managed with MDI or SMBG were enrolled and randomized either to the AHCL or the MDI+SMBG group. Of these, 37 (90%) participants (mean age 40.3 years, SD 8.0 years; mean duration of diabetes 17.3, SD 12.1 years; mean hemoglobin A1c [HbA1c] 7.2%, SD 1.0%) completed the study (AHCL: n=20, 54%; MDI+SMBG: n=17, 46%). Psychological parameters (level of stress, coping mechanisms, level of anxiety, self-efficacy level, acceptance of illness, locus of control of illness, life satisfaction, QoL) were measured at baseline and at the end of the study using 10 psychological questionnaires. RESULTS: At baseline, the general level of stress of the examined patients was higher than in the general healthy Polish population (P=.001), but coping strategies used in stressful situations were significantly more effective and the level of self-efficacy (P<.001) was much higher than in the general population. The patients in this study accepted their illness more than patients with diabetes from the general Polish population (P<.001), but they felt that their health does not depend on them compared to the general population (P<.001). The overall life satisfaction was similar to that of the general population (P=.161). After 3 months from transition, the AHCL group reported an increase in 4 scales of the QoL-feeling well (P=.042), working (P=.012), eating as I would like (P=.011), and doing normal things (P=.034)-in comparison to the control group, where no significant change occurred. The level of both state anxiety and trait anxiety decreased in the AHCL group: State-Trait Anxiety Inventory (STAI) X1 scores (P=.009), STAI X1 stens (P=.013), and STAI X2 scores (P=.022). The AHCL group became more emotion oriented in stressful situations (Coping Inventory for Stressful Situations [CISS] E; P=.043) and significantly less self-blaming after 3 months of the study (P=.020). CONCLUSIONS: The results indicate that the patients who decided to take part in the transition study were characterized by higher levels of stress than the general healthy population but had better coping strategies and self-efficacy. Furthermore, transitioning from MDI+SMBG treatment to the AHCL in patients naive to technology may significantly improve psychological well-being and QoL within 3 months. The rapidity of these changes suggests that they may be related to the significant improvement in glycemic outcomes but also significantly less burdened diabetes self-management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04616391; https://clinicaltrials.gov/ct2/show/NCT04616391.

Type 1 Diabetes Mellitus and Lipohypertrophy - Impact of the Intervention on Glycemic Control via Patient's Examination and Retraining on Change of Infusion Set.

OBJECTIVE: Lipohypertrophy (LH) is a common complication of insulin therapy in type 1 diabetes mellitus (T1DM). We examined whether an intervention consisting of LH assessment and retraining on insulin infusion set use improves glycemic control on subcutaneous insulin infusion (CSII) in patients with T1DM. METHODS: The intervention was conducted in 79 consecutive patients with T1DM. Data on glucose levels, glycated hemoglobin (HbA1c), and insulin doses were collected at baseline and after a median of 22 weeks (20-31.75 weeks). RESULTS: A total of 46 patients with T1DM (23 [50%] women) participating in the follow-up were characterized by a median age of 29 years (25-33.8 years), body mass index of 24.6 ± 3.3 kg/m2, T1DM duration of 16.5 years (8.3-20 years), and subcutaneous insulin infusion duration of 7 years (4-10.8 years). Patients' median HbA1c fell from 7.4% (6.7%-8.2%) to 7.05% (6.4%-7.6%) (P < .001), daily insulin dose/kg decreased (0.7 ± 0.20 vs 0.68 ± 0.15 IU/kg; P = .017) together with the total daily insulin dose (50.3 [40.5-62.7] vs 47.6 [39.8-62.1] IU; P = .019]. Furthermore, the percentage of basal insulin dose increased (43.0% [36-50] vs 44.0% [39.0-50.0]; P = .010], whereas the percentage of bolus dose decreased (57% [50-64] vs 56% [50-61], P = .010). CONCLUSIONS: The structured LH-related intervention in patients with T1DM on insulin pumps resulted in better glycemic control and a decrease in total daily insulin dose.

Association of short- and long-term metabolic control parameters with personality traits in adult type 1 diabetes treated with personal insulin pumps. / Korelacja krótko- i dlugoterminowych parametrów kontroli metabolicznej z cechami osobowosci u doroslych chorych na cukrzyce typu 1 leczonych za pomoca osobistych pomp insulinowych.

AIM: Several studies have assessed the association between personality traits and metabolic outcomes in children and adolescents with type 1 diabetes (T1DM). The aim of this observational single-visit study was to investigate whether specific personality traits were related to the degree of metabolic control/diabetes duration in adult T1DM patients. METHOD: Data were collected from 56 adults (40 men) with T1DM treated in a tertiary care center. "Big Five" personality traits were assessed using the NEO-Five Factor Inventory questionnaire. Several variables were obtained from the insulin pumps, glucometers and blinded continuous glucose monitoring system. RESULTS: All personality traits but neuroticism (low level of the trait) showed average intensity. Agreeableness was associated with most variables from CGMS data. Higher conscientiousness was associated with longer diabetes duration. Higher neuroticism was correlated with greater glycemic variability (GV), while high Extraversion was associated with lower GV. Lower Openness was associated with prolonged time in clinically significant hypoglycaemia. CONCLUSIONS: Our study suggest that personality traits manifest in individual approach to diabetes management and emotion regulation, translating also into the attitude to treatment. On the other hand, T1DM patients' overall trait scores were consistent with healthy nonpsychiatric norms, which debunks myths and stereotypes suggesting that chronic disease is usually associated with psychopathology.

Assessment of the spectrum of depression and bipolarity in patients with type 1 diabetes.

AIMS: The aim of the study was to check the prevalence of unipolarity (depression), bipolarity, as well as the quality of sleep and temperament traits in patients with type 1 diabetes (T1DM) who are provided with optimal conditions of diabetes care and to identify possible risk factors connected with affective traits. MATERIALS AND METHODS: Out of the 107 T1DM patients, 78 (54 females, 24 males) were included for the analysis (HbA1c [%] 7.11 ± 1.0, BMI [kg/m2 ] 25.3 ± 5.6; Years of disease duration [N] 13.7 ± 8.3). The patients filled in a set of questionnaires during their regular visit to the outpatient clinic. Three patients from the whole group were on intensive insulin therapy with Multiple Daily Injections (MDI) and Self-Monitoring of Blood Glucose (SMBG), all the rest were on various types of personal insulin pumps (years on insulin pump [N] 9.1 ± 4.5). All the patients were on regular diabetologist care, with regular visits in a Centre for Advanced Technologies in Diabetes (at least every 6 months). RESULTS: In QIDS-S (full explanation and abbreviation 26 patients (33.8%) were screened positive for depression, in PHQ (full explanation and ab 57.7% of the patients (45 patients) had symptoms of depression (age was negatively correlated with PHQ score [r = -0.26; p = 0.023]). In CES-D 16 (20%) of the patients assessed their present affect as depressed. None of the analysed clinical variables correlated with depression scores. In the Mood Disorder Questionnaire (MDQ), 16 patients reported having symptoms of bipolarity (20.5% vs. 79.5%). Hypomania Checklist (HCL) analysis indicated 10 patients with bipolar traits (>14) (14.9% vs. 85.1%). None of the analysed clinical variables correlated with HCL results. 11.5% of patients were indicated to be of morning type. Morningness was more often seen in younger patients (r = 0.39; p = 0.001). As many as 46.6% declared that they had poor sleep quality. The temperament traits analysis correlated with clinical parameters: Cyclothymic temperament trait was negatively correlated with age (r = -0.30; p = 0.007) and positively with HbA1c level (r = 0.30; p = 0.025). Hyperthymic temperament was positively correlated with (BMI r = 0.28; p = 0.016). Quality of sleep was highly correlated with depressive symptoms CESD (r = 0.61, p = 0.001), PHQ Score (r = 0.62; p = 0.001), QISD (r = 0.68; p = 0.001) and bipolarity MDQ (p = 0.50, p = 0.001) and HCL (r = 0.42, p = 0.001). In addition, QIDS was shown to be correlated with the following features of temperament: depressive factor (r = 0.41; p = 0.001), irritable factor (r = 0.53; p = 0.001), cyclothymic factor (r = 0.59; p = 0.001), anxious factor (r = 0.58, p = 0.001). CONCLUSIONS: The prevalence of affective disorders and poor sleep quality in the examined T1DM patients was much higher than in the general population. Even if the patients have in general good glycaemic control, their mental health condition should not be neglected. Well organised cooperation between patients, diabetologists, psychiatrists and psychotherapists is needed (Clinical Trials Identifier: NCT04616391).

Transitioning of People With Type 1 Diabetes From Multiple Daily Injections and Self-Monitoring of Blood Glucose Directly to MiniMed 780G Advanced Hybrid Closed-Loop System: A Two-Center, Randomized, Controlled Study.

OBJECTIVE: The aim of this study was to evaluate the outcomes of transitioning to the MiniMed 780G advanced hybrid closed-loop (AHCL) system in adult individuals with type 1 diabetes mellitus (T1DM) naive to continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) technologies. RESEARCH DESIGN AND METHODS: This was a two-center, randomized, controlled, parallel-group trial with evaluation of individuals with T1DM aged 26-60 years managed with multiple daily injections (MDI) and self-monitoring of blood glucose (BGM) with HbA1c <10%. RESULTS: A total of 41 participants were recruited and randomized to either the AHCL (n = 20) or the MDI+BGM (n = 21) group, and 37 participants (mean ± SD age 40.3 ± 8.0 years, duration of diabetes 17.3 ± 12.1 years, BMI 25.1 ± 3.1 kg/m2, HbA1c 7.2 ± 1.0%) completed the study. Time spent with glucose levels in target range increased from 69.3 ± 12.3% at baseline to 85.0 ± 6.3% at 3 months in the AHCL group, while remaining unchanged in the control group (treatment effect 21.5% [95% CI 15.7, 27.3]; P < 0.001). The time with levels below range (<70 mg/dL) decreased from 8.7 ± 7.3% to 2.1 ± 1.7% in the AHCL group and remained unchanged in the MDI+BGM group (treatment effect -4.4% [95% CI -7.4, -2.1]; P < 0.001). Participants from the AHCL group also had significant improvements in HbA1c levels (treatment effect -0.6% [95% CI -0.9, -0.2]; P = 0.005) and in quality of life (QoL) in specific subscales compared with the MDI+BGM group. CONCLUSIONS: People with T1DM naive to CSII and CGM technologies initiating AHCL significantly and safely improved their glycemic control, as well as their QoL and psychological well-being.

Insulin-induced Lipohypertrophy in Patients with Type 1 Diabetes Mellitus Treated with an Insulin Pump.

BACKGROUND: Lipohypertrophy (LH) of subcutaneous tissue is an insulin-induced complication occurring in patients with diabetes. We aimed to define the prevalence of LH and identify its risk factors in type 1 diabetes (T1DM) patients treated with continuous subcutaneous insulin infusion (CSII). MATERIALS AND METHODS: The study included 79 consecutive CSII-treated T1DM patients. The diagnose of LH was based on ultrasonography (US) as a reference method, physical examination was also performed. Clinical characteristics were available from the medical records. RESULTS: The median age of patients was 28 years (interquartile range [IQR], 24-30.5) with a body mass index (BMI) of 24.5 ± 3.5 kg/m2, HbA1c 7.1% (IQR, 6.7-8.1), T1DM duration 15 (9-20) years, and CSII use duration of 8 year (IQR, 5-11). LH was detected by US in 75 (94.9%) patients. This value was much higher than this obtained by visual assessment (n = 39, 49.4%) or palpation (n = 59, 74.7%). In univariate analyses, the following risk factors for occurrence of 5 and more LH lesions were identified: the ratio of insulin dose to body mass exceeding 0.7 IU/kg (OR, 3.69; 95% CI, 1.43-10.01) and the total daily insulin dose (OR, 1.05; 95% CI, 1.02-1.09). A higher dose of insulin per kg remained a significant risk factor of LH amount in multivariate analysis. CONCLUSION: This selected T1DM cohort treated with CSII had a very high prevalence of LH. US assessment should be considered as a reference method for LH screening in T1DM patients. The identified risk factors for the number of LH lesions were related to insulin dosing.

Low prevalence of diabetic retinopathy in patients with long-term type 1 diabetes and current good glycemic control - one-center retrospective assessment.

PURPOSE: Despite progress in type 1 diabetes (T1DM) therapy, diabetic retinopathy (DR) is still a common complication. We analysed predictors and prevalence of DR in patients with T1DM lasting 10 years or more. All of the patients were considered to be currently in excellent glycemic control and treated using modern therapies. METHODS: Study included 384 (80.7% women) T1DM patients participating in the Program of Comprehensive Outpatient Specialist Care at the University Hospital in Krakow between the years 2014 and 2020. A retrospective analysis of medical records was conducted. RESULTS: The patients were on average 34 ± 9.2 years old, had a BMI 25.0 ± 3.9 and a T1DM duration of 20.5 ± 7.9 years. The mean level of HbA1c throughout the follow-up (mean duration 4.9 ± 1.4 years) was 6.9 ± 1%. The group included 238 (62.0%) patients treated with insulin pumps and 99 (25.8%) on multiple daily injections, 47 (12.2%) used both methods; almost all patients were on insulin analogues. DR was confirmed in 150 (39.1%) patients, from which 109 (28.4%) were diagnosed de novo. Severe DR was occurred in just 31 cases (8.1%). In the multivariate logistic regression, independent risk factors for the presence of DR were T1DM duration (OR 1.13; 95% CI, 1.09-1.19), HbA1c level (OR 1.41; 95% CI, 1.08-1.84), LDL level (OR 1.79; 95% CI, 1.16-2.87), and the combined presence of non-DR micro- and macrovascular chronic complications (OR 1.86; 95% CI, 1.16-3.03). CONCLUSIONS: In this highly-selected group of T1DM patients, mostly female, the prevalence of both DR at any stage and severe DR was lower than earlier reported results from other cohorts. Independent risk factors for the DR cohort did not differ from previously reported studies.

Habits related to the use of insulin infusion set in patients with type 1 diabetes on pump therapy - the effect of the educational intervention.

INTRODUCTION: Proper use of insulin infusion sets (IIS) plays an important role in pump therapy of patients with type 1 diabetes mellitus (T1DM). We assessed the habits associated with the use of IIS in patients with T1DM treated with insulin pump. MATERIALS AND METHODS: This study included 79 T1DM patients who were examined for the presence of lipohypertrophy (LH) and retrained for proper IIS use. They completed a standard questionnaire regarding IIS at the time of study entry and at the follow-up. R e s u l t s: At baseline, most of the patients declared to have been using a plastic cannula (n = 68; 86.1%), changing the infusion set regularly (n = 65; 82.3%), and placing the infusion sets on the abdomen wall (n = 68; 86.1%). The most common rotation habit was the "curve pattern" on both sides of the umbilicus (n = 16; 20.3%). After a median of 23 weeks (IQR 20-34), 58 patients were available for the follow-up. A rise in the proportion of patients who declared to change IIS regularly (n = 48; 82.8% vs. n = 57; 98.3%, p = 0.016), change IIS every 2 to 3 days (n = 27; 46.6% vs. n = 35; 60.3%, p = 0.043), use "crisscross" rotation (n = 5; 8.8% vs. n = 12; 21.4%, p = 0.027) was observed. There were less patients reporting not having repeatable rotation manner (n = 15; 26.3% vs. n = 2; 5.4%, p = 0.009). C o n c l u s i o n s: A substantial proportion of T1DM patients on pump therapy declare that they do not follow the recommended principles of IIS use. The intervention consisting of LH assessment and retrain- ing of proper use of IIS might be effective in improving patient compliance.

Type 1 Diabetes and COVID-19: the level of anxiety, stress and the general mental health in comparison to healthy control. / Cukrzyca typu 1 i COVID-19: poziom leku, stresu i ogólnego stanu zdrowia psychicznego u pacjentów w porównaniu z grupa kontrolna.

OBJECTIVES: Assessment of mental state of patients with T1DM - the level of anxiety, stress and general mental health in the stressful conditions of an epidemic. Moreover, it was checked whether the stress response to the epidemic in the T1DM group differed from that in the control group. This is the first study to address these questions in the type 1 diabetes population in Poland. METHODS: An e-mail was sent to all T1DM patients under the care of a diabetes clinic with information about the possibility of online consultation with a psychologist / psychiatrist, with a set of psychological tests attached. The study included 49 patients with T1DM who responded within the first month and agreed to participate in the study. 38 people from the control group were randomly recruited. Each person completed a set of psychological tools. RESULTS: In both groups, the level of stress was higher than typical for the general population in the situation without stressor. T1DM patients who have been ill for over 10 years more often cope with stress through a task-oriented approach. Patients who have been ill for less than 10 years use avoidance strategies. In the first phase of the epidemic,women with T1DM used avoidance strategies. Patients with diabetes and mental disorders react more anxiously and thus require special care in coping with diabetes. CONCLUSIONS: In a situation of stress such as a epidemic, patients suffering from T1DM require optimization of treatment and cooperation of specialists in the field of diabetes and psychology / psychiatry.

Changes in Oxidative and Nitrosative Stress Indicators and Vascular Endothelial Growth Factor After Maximum-Intensity Exercise Assessing Aerobic Capacity in Males With Type 1 Diabetes Mellitus.

In type 1 diabetes mellitus (T1DM), chronic hyperglycemia causes reactive oxygen and nitrogen species production. Exercise alters the oxidant-antioxidant balance. We evaluated the aerobic capacity and oxidant-antioxidant balance changes after maximum-intensity exercise in T1DM patients. The study involved 30 T1DM participants and 23 controls. The patients' average age was 23.4 ± 5.1 years, with a body mass index of 24.3 ± 3.1 kg m-2 and with satisfactory glycemic control. Among the controls, the respective values equaled 24.7 ± 2.9 years and 22.9 ± 2.1 kg m-2. Aerobic capacity was assessed with a treadmill test. Peak minute oxygen uptake was significantly lower in T1DM compared with the controls (44.7 ± 5.7 vs. 56.0 ± 7.3 mL kg-1 min-1). The total oxidant capacity measured by total oxidative status/total oxidative capacity (TOS/TOC) equaled 321.5 ± 151 µmol L-1 before and 380.1 ± 153 µmol L-1 after exercise in T1DM, and 164.1 ± 75 and 216.6 ± 75 µmol L-1 in the controls (p < 0.05 for all comparisons). A significant difference in the ratio of total antioxidant status/total antioxidant capacity (TAS/TAC) between the groups after the treadmill test was observed (p < 0.05). Nitrosative stress indicators where significantly higher in the T1DM group both before and after the exercise. In conclusion, diabetic patients demonstrated a lower aerobic capacity. The TOS/TOC and nitrosative stress indicators were significantly higher in T1DM before and after the test.

The enteroendocrine-osseous axis in patients with long-term type 1 diabetes mellitus.

INTRODUCTION: The relationship between the gut and skeleton is increasingly recognized as a component of the regulation of carbohydrate metabolism. The aim of our study was to assess the relationship between bone mineral density (BMD), incretin hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), intestinotrophic peptide glucagon-like peptide-2 (GLP-2) and osteocalcin isoforms in patients with long-term type 1 diabetes (T1D) when compared to healthy controls. METHODS: Eighty two patients with long term T1D, treated in the Department of Metabolic Diseases and 53 healthy controls were recruited to the study. Long term disease duration was defined as lasting for more than 10 years. The control group was selected among age- and sex-matched healthy people. Fasting blood samples were collected to measure levels of incretin hormones (GLP-1, GLP-2, GIP), two forms of osteocalcin (uncarboxylated (ucOC), and carboxylated (cOC)), and additional biochemical parameters associated with glucose and bone metabolism (HbA1c, calcium, phosphorus, 25(OH)D3, PTH). RESULTS: Patients with T1D had higher BMI than in controls (p = 0.02). There was no difference in BMD at the lumbar spine and the femoral neck between patients with long-term T1D and healthy ones. Z-score values in both groups were within normal ranges. The level of GIP was significantly higher in T1D patients (p = 0.0002) in comparison to the healthy ones. The levels of GLP-1 and GLP-2 did not differ between T1D patients and controls. In the T1D group, strong, positive associations were found between serum levels of GLP-1 and cOC (r = 0.546, p < 0.001) and between GLP-1 and total OC (r = 0.51, p < 0.001), also after adjusting for BMI (p < 0.001 and p < 0.001, respectively). Significant positive associations were also found between serum levels of GLP-2 and cOC (r = 0.27, p = 0.013) and between GLP-2 and total OC (r = 0.25, p = 0.018), also in a multivariate regression (p = 0.009, p = 0,175, respectively). Moreover, in T1D patients, GLP-1 correlated positively with the femoral neck BMD (g/cm2) (r = 0.265, p = 0.016) and this association was statistically significant after adjusting for BMI (p = 0.011). These correlations were not present in the control group. The only significant correlation observed in the control group was between OC and BMD of the neck (p = 0.049 for neck BMD g/cm2, and p = 0.041 for neck Z-score). CONCLUSIONS: Our data suggests an effect of gut hormones on bone in long-term T1D, which could be associated with OC activity, however we did not find a direct connection with glucose metabolism. GLP-1 could have a possible, protective role on bone mineral density in patients with T1D. The data from our study suggests that gut hormones could be considered as a new link in the skeleton - pancreatic endocrine loop in patients with T1D.