scholarly journals Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e027913
Author(s):  
Desiree Ruiz-Aranda ◽  
Davinia M Resurrección ◽  
Mencia R Gutierrez-Colosia ◽  
Maria Asuncion Martinez-Brocca

IntroductionType 1 diabetes mellitus (T1DM) is one of the most frequent chronic endocrine diseases in the paediatric population. As a result, this disease has a strong impact on psychological well-being. In line with this, emotional factors play an important role in adaptation. The aim of the present study protocol is to design an emotional abilities programme to improve metabolic control assessed by haemoglobin A1c (HbA1c) samples. Specifically, this intervention will be focused on adaptive coping strategies to deal with unpleasant emotions associated with T1DM. The primary aim of this project is to assess whether the employment of this new psychological intervention improves the emotional abilities of adolescents with T1DM.Methods and analysisTwo focus groups will be carried out for the design and evaluation of the programme following the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects/safety and equity). Behavioural change will be based on the Behaviour Change Wheel. Sixty-two participants from 12 to 18 years of age will be recruited at a public hospital and randomised to either an intervention or a control group. The intervention group will receive an emotional abilities training programme. The control group will receive usual educational intervention. The primary outcomes are metabolic control and emotional abilities. The secondary outcomes include emotional distress control, positive and negative affect, healthy habits, and quality of life. Data will be collected at baseline, immediately postintervention, and at follow-up visits at 6 and 12 months. A feasibility analysis will be conducted.Ethics and disseminationThe study has been approved by the Ethics Committee of Universidad Loyola Andalucía. Results will be submitted for publication in peer-reviewed journals and disseminated across the scientific community.Trial registration numberNCT03734367.

2017 ◽  
Vol 2017 ◽  
pp. 1-9 ◽  
Author(s):  
Agnieszka Kowalska ◽  
Katarzyna Piechowiak ◽  
Anna Ramotowska ◽  
Agnieszka Szypowska

Background. The ELKa system is composed of computer software, with a database of nutrients, and a dedicated USB kitchen scale. It was designed to automatize the everyday calculations of food exchanges and prandial insulin doses. Aim. To investigate the influence of the ELKa on metabolic control in children with type 1 diabetes mellitus (T1DM). Methods. A randomized, parallel, open-label clinical trial involved 106 patients aged <18 years with T1DM, HbA1C≤10%, undergoing intensive insulin therapy, allocated to the intervention group, who used the ELKa (n=53), or the control group (n=53), who used conventional calculation methods. Results. After the 26-week follow-up, the intention-to-treat analysis showed no differences to all endpoints. In per protocol analysis, 22/53 (41.5%) patients reporting ELKa usage for >50% of meals achieved lower HbA1C levels (P=0.002), lower basal insulin amounts (P=0.049), and lower intrasubject standard deviation of blood glucose levels (P=0.023) in comparison with the control. Moreover, in the intervention group, significant reduction of HbA1C level, by 0.55% point (P=0.002), was noted. No intergroup differences were found in the hypoglycemic episodes, BMI-SDS, bolus insulin dosage, and total daily insulin dosage. Conclusions. The ELKa system improves metabolic control in children with T1DM under regular usage. The trial is registered at ClinicalTrials.gov, number NCT02194517.


2021 ◽  
pp. 1-5
Author(s):  
Mehmet Türe ◽  
Alper Akın ◽  
Edip Unal ◽  
Ahmet Kan ◽  
Suat Savaş

Abstract Background: Adult patients diagnosed with type 1 diabetes mellitus are at risk for ventricular arrhythmias and sudden cardiac death. Aim: The objective of our study is to evaluate the electrocardiographic data of children diagnosed with type 1 diabetes mellitus and to determine the possibility of arrhythmia in order to prevent sudden death. Methods: Electrocardiographic data of 60 patients diagnosed with type 1 diabetes mellitus and 86 controls, who were compatible with the patient group in terms of age and gender, were compared. Results: The duration of diabetes in our patients with type 1 diabetes mellitus was 5.23 ± 1.76 years, and the haemoglobin A1c levels were 9.63% ± 1.75%. The heart rate, QRS, QT maximum, QT dispersion, QTc minimum, QTc maximum, QTc dispersion, Tp-e maximum, Tp-e maximum/QTc maximum and the JTc were significantly higher compared to the control group. There was no significant correlation between the duration of type 1 diabetes mellitus and HbA1c levels and the electrocardiographic data. Conclusion: We attributed the lack of a significant correlation between the duration of type 1 diabetes mellitus and the haemoglobin A1c levels and the electrocardiographic data to the fact that the duration of diabetes was short, since our patients were children. We believe that patients with type 1 diabetes mellitus should be followed up closely in terms of sudden death, as they have electrocardiographic changes that may cause arrhythmias compared to the control group. However, more studies with longer follow-up periods are necessary to support our data.


2014 ◽  
Vol 60 (1) ◽  
pp. 39-45
Author(s):  
L I Ibragimova ◽  
Yu I Philippov ◽  
A Yu Mayorov

Aim of the study. To estimate the effectiveness of the new program of structured diabetes education for the groups of the patients with type 1 diabetes mellitus (DM1) during their transition to sensor-augmented pump (SAP) therapy in terms of improvement of the glycemic control and quality of life (QL). Material and methods. The study included 35 patients presenting with DM1: 14 men, mean age 26.5 years (24; 36). The patients were divided into two groups. Those in the study group received a structured diabetes education (n=19), those in the control group were given conventional education (n=16). The patients of group 1 were transferred to SAP therapy in the framework of group education based on the specialized structured program. The education of control patients was carried out on an individual basis in the previous period at the places of residence. Quality of life and emotional well-being were estimated with the use of the validated Russian versions of the SF-36, ADDQoL, and WB-Q12 questionnaires. The effectiveness of glycemic control and QL were evaluated within 4 months after the completion of education and transition to SAP. Results. The patients of both groups were not initially different in the HbA1c level: 8.1 (8.0; 9.2) versus 8.8 (7.7; 9.0) (p>0.05). The HbA1c level: decreased in the two groups within 4 months after the initiation of SAP therapy: 7.3 (6.3; 7.8) versus 8.0 (6.3; 8.5) (p>0.05). The decrease was more pronounced in the group of the patients who received the structured diabetes education than in the control group (p=0.036). The patients transferred to SAP in the framework of the structured education program tended to have higher indices of QL and emotional well-being than the patients given the standard education. Conclusion. The use of the specialized structured program for the education for the groups of the patients with type 1 diabetes mellitus during transition to SAP therapy results not only in a more pronounced improvement of glycemic control indices but also in the positive changes of certain QL characteristics.


Open Medicine ◽  
2009 ◽  
Vol 4 (4) ◽  
pp. 415-422
Author(s):  
Kamile Gul ◽  
Ihsan Ustun ◽  
Yusuf Aydin ◽  
Dilek Berker ◽  
Halil Erol ◽  
...  

AbstractThe aim of the study was to determine the frequency and titers of anti-thyroid peroxidase (Anti-TPO), anti-thyroglobulin (Anti-TG), and anti-glutamic acid decarboxylase (Anti-GAD) antibodies in Turkish patients with type 1 diabetes mellitus (DM), and to compare the frequency of anti-TPO and anti-TG titers in the presence or absence of anti-GAD. A total of 104 patients including 56 males and 48 females with type 1 DM and their age-, gender-, and body mass index-matched control group, including 31 males and 27 females, 58 cases in total with an age range of 15-50 years, were recruited into this study. In patients with type 1 DM, positive anti-GAD was detected in 30.8% (n=32). In patients with positive anti-GAD, rate of positive anti-TPO was 37.5%; however, in patients with negative anti-GAD, the rate of positive anti-TPO was 9.7% and the difference was statistically significant (p=0.001). In patients with positive anti-GAD, the rate of positive anti-TG was 18.8%. In patients with negative anti-GAD, the rate of positive anti-TG was 2.8%, and the difference between them was statistically significant (p=0.005). In patients with positive and negative anti-GAD, rates of both positive anti-TPO and anti-TG were 15.6% and 1.4%, respectively, with the difference showing statistical significance (p=0.004). Thyroid autoimmunity in type 1 DM patients with positive anti-GAD was apparently higher; therefore, these patients should be followed more frequently and carefully.


2013 ◽  
Author(s):  
Joana Caetano ◽  
Sara Ferreira ◽  
Ester Pereira ◽  
Marta Ferreira ◽  
Helena Lourenco ◽  
...  

Author(s):  
Shih-Yi Lin ◽  
Cheng-Li Lin ◽  
Cheng-Chieh Lin ◽  
Wu-Huei Hsu ◽  
Chung-Y. Hsu ◽  
...  

Type 1 diabetes mellitus (T1DM) has been linked to many autoimmune problems. The association between T1DM and urticaria warrants investigation. Data were extracted from the National Health Insurance Research Database (NHIRD) of Taiwan. Participants with T1DM were recruited as the case group, and that group was matched by sex and age at a ratio of 1:4 to the control group comprising those without T1DM. The study period was 1998–2011. All participants were followed up to the diagnosis of urticaria, withdrawal from the insurance program, death, or the end of the study. A multivariable Cox proportional hazard model was used to calculate the adjusted and crude hazard ratios for urticaria. A total of 5895 participants (1179 in the case group and 4716 in the control group) were followed up in the study. The total incidence rate of urticaria in patients with type 1 DM was 26.6 per 1000 person-years, and that in controls was 6.85 per 1000 person-years. Compared with the control group, the hazard ratio of urticaria in the case group was 2.84 (95% CI = 2.27–3.56). Compared with age-matched participants without T1DM, patients with type 1 DM aged <18 years had a 3.62-fold higher risk of urticaria (95% CI = 2.85–4.59). The hazard ratio in patients with an adjusted Diabetes Complications Severity Index (aDCSI) score of 1.01–2.00 per year was 2.57 (95% CI = 1.18–5.57), and that in patients with an aDCSI score of >2.00 per year was 4.47 (95% CI = 2.68–7.47). T1DM patients aged <18 years had an increased risk of urticaria, but a similar phenomenon was not observed among T1DM patients older than 18 years.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Phillip Trefz ◽  
Juliane Obermeier ◽  
Ruth Lehbrink ◽  
Jochen K. Schubert ◽  
Wolfram Miekisch ◽  
...  

Abstract Monitoring metabolic adaptation to type 1 diabetes mellitus in children is challenging. Analysis of volatile organic compounds (VOCs) in exhaled breath is non-invasive and appears as a promising tool. However, data on breath VOC profiles in pediatric patients are limited. We conducted a cross-sectional study and applied quantitative analysis of exhaled VOCs in children suffering from type 1 diabetes mellitus (T1DM) (n = 53) and healthy controls (n = 60). Both groups were matched for sex and age. For breath gas analysis, a very sensitive direct mass spectrometric technique (PTR-TOF) was applied. The duration of disease, the mode of insulin application (continuous subcutaneous insulin infusion vs. multiple daily insulin injection) and long-term metabolic control were considered as classifiers in patients. The concentration of exhaled VOCs differed between T1DM patients and healthy children. In particular, T1DM patients exhaled significantly higher amounts of ethanol, isopropanol, dimethylsulfid, isoprene and pentanal compared to healthy controls (171, 1223, 19.6, 112 and 13.5 ppbV vs. 82.4, 784, 11.3, 49.6, and 5.30 ppbV). The most remarkable differences in concentrations were found in patients with poor metabolic control, i.e. those with a mean HbA1c above 8%. In conclusion, non-invasive breath testing may support the discovery of basic metabolic mechanisms and adaptation early in the progress of T1DM.


1991 ◽  
Vol 37 (10) ◽  
pp. 1696-1699 ◽  
Author(s):  
C D Agardh ◽  
E Agardh ◽  
A Isaksson ◽  
B Hultberg

Abstract Urinary N-acetyl-beta-glucosaminidase (NAG) and its isoenzymes (NAG A and NAG B) in samples from 87 type 1 diabetic patients and 40 apparently healthy reference subjects were studied with enzyme immunoassays. The diabetic patients had higher concentrations of urinary NAG than did the control subjects (P less than 0.01), but the isoenzyme pattern did not differ. There was a positive correlation between metabolic control (Hb A1c concentrations) and total NAG (P less than 0.01), NAG A (P less than 0.01), and NAG B (P less than 0.001). The diabetic patients were divided into three groups, depending on the degree of retinopathy. Subjects with severe forms of retinopathy did not have increased concentrations of urinary NAG unless they had concomitant nephropathy. The isoenzyme pattern was similar irrespective of degree of retinopathy or nephropathy. The results indicate that concentrations of urinary NAG are positively correlated to the degree of nephropathy, whereas there is no such correlation to the degree of retinopathy.


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