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.

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.

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.

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.

Efficacy and safety of long-term insulin pump treatment in patients with type 1 diabetes aged over 50 years.

Continuous subcutaneous insulin infusion (CSII) therapy using insulin pumps has become widely used in the treatment of type 1 diabetes mellitus (T1DM). This retrospective study aimed to assess the efficacy and safety of long-term insulin pump treatment in patients with T1DM aged ≥50 years. The study included patients aged ≥50 years, who had a diagnosis of T1DM based on clinical criteria and/or presence of autoantibodies characteristic of autoimmune diabetes, and had received ≥5 years of recent and uninterrupted treatment with a personal insulin pump. We analyzed records on HbA1c levels across the entire observation period. The cohort comprised 17 patients, of whom 6 (35%) were men and 11 (65%) were women. The mean duration of observation was 6.6 years, during which patients had a mean of 8.4 HbA1c measurements. Mean HbA1c level over the entire observation period was 6.7% (range, 5.3-7.4%). Overall, 11 patients (65%) had mean HbA1c levels at the ADA-recommended target of <7% and 5 patients (29%) had mean HbA1c <6.5%. Mean HbA1c level was significantly lower at the end of the observation period than at the start (6.52% versus 6.91%; difference, -0.39%; p < 0.01), indicating an improvement in glycaemic control over time. On average, patients experienced one level 1 hypoglycaemia episode every 2.4 days. This retrospective analysis of at least 5 years of follow-up of selected patients with T1DM aged ≥50 years at the start of observation, showed that CSII is a safe and effective treatment option in this age group.

Changes in the clinical characteristics of women with gestational diabetes mellitus - a retrospective decade-long single center analysis.

AIMS: Gestational diabetes mellitus (GDM) is an emerging worldwide problem. Changes in clinical characteristics of women affected by GDM in a long-term perspective are still not properly investigated. We aimed to examine such changes over a decade in a retrospective single-center analysis. METHODS: The medical documentation from Department of Metabolic Diseases, Krakow, Poland was analyzed. We included 633 women consecutively diagnosed with GDM in one of three time intervals: 2007-2008 (N = 157), 2012-2013 (N = 272), 2016-2017 (N = 234). Statistical analyses were performed. RESULTS: Comparison of the three groups identified differences in the mean age of women at the GDM diagnosis (30.7 ± 5.0 years vs. 31.2 ± 4.7 vs. 32.5 ± 4.7, respectively, starting from the earliest 2007-2008 group), pregnancy week at GDM diagnosis (28.0 ± 5.3 wks. vs. 25.9 ± 4.9 vs. 23.4 ± 6.8), the proportion of women diagnosed before the 24th week of pregnancy (12.8% vs. 16.5% vs. 31.3%), and gestational weight gain (12.4 ± 5.0 kg vs. 10.4 ± 5.2 vs. 10.0 ± 5.7); (p = 0.001 or less for all comparisons). We also found differences for glucose values on fasting and at 2 hours with the highest (0 min) and lowest level (120 min) in the 2016-2017, respectively. Finally, a borderline difference for the weight, but not for BMI, was found (64.1 ± 14.1 kg vs. 66.2 ± 13.1 vs. 67.8 ± 15.6; p = 0.04). Differences were also identified in the post hoc analysis between cohorts. CONCLUSION: This retrospective analysis illustrates changes in characteristics of women with GDM occurring over the period of decade in Poland. They likely result from both epidemiological trends and modifications of the WHO criteria for the GDM diagnosis.

Assessment of selected food intake frequency in patients with type 1 diabetes treated with personal insulin pumps

Background: It has been established that in Type 1 Diabetes Mellitus (T1DM), regardless of the insulin therapy model used, diet and proper eating habits are still important in the treatment of the disease. The dietary intervention in these patients is aimed at maintaining proper body weight, obtaining target fasting and post meal blood glucose levels, optimizing lipid profiles. Objective: The aim of the study was to assess dietary habits in a homogeneous group of adults with T1DM treated with personal insulin pumps. Material and methods: The study included 141 adult patients (57% women) with type 1 diabetes treated with personal insulin pumps. The surveyed population was characterized by an average age of 25.8 ± 6.2 years, an average duration of diabetes 13.9 ± 6.9 years, and treatment with a personal pump for 8.2 ± 4.1 years and mean BMI 23.0 ± 2.8 g/m2. All were dwellers of south-eastern Poland. The validated KomPAN questionnaire was used to assess the frequency of consumption of individual food products. Results: The mean percentage of HbA1c in the study group was 7.3% [56 mmol/mol]. The mean total cholesterol level was 4.4 mmol/l, HDL - 1.7 mmol/l, LDL - 2.3 mmol/l and triglycerides - 0.8 mmol/l. In the multivariate regression model, no correlation was found between dietary quality parameters and metabolic compensation measured with HbA1c or lipidogram and the place of residence (village, small town, big city). However, there were differences in the quality of the diet depending on the sex. Women were characterized by higher index of a healthy diet (pHDI-10) (26.3 vs 21.4, p=0.005) and lower index of unhealthy diet (nHDI-14) (13.3 vs 18.6, p <0.001) than men. Conclusions: The results of this study clearly suggest, that despite good metabolic control, patients require more education on the choice of healthy product groups.