title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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cGMP induces cardioprotection. | ( | PMC10471167 | ||
RBCs release a cardioprotective factor dependent on sGC following nitrate administration and hypoxia. | Percentage recovery of LVDP during reperfusion ( | PMC10471167 | ||
The nitrate-mediated protective effect of RBCs is dependent on sGC and transport by MRP. | Percentage recovery of LVDP during reperfusion ( | PMC10471167 | ||
RBCs mediate cardioprotection via activation of cardiac PKG. | ( | PMC10471167 | ||
Inhibition of cardiac protein kinase G abolishes cardioprotection induced by RBCs from nitrate-treated mice. | Percentage recovery of LVDP during reperfusion following administration of RBCs from ( | PMC10471167 | ||
Increased expression of phosphorylated VASP in cardiomyocytes by hypoxic RBCs. | ( | PMC10471167 | ||
Dietary nitrate in humans enables RBCs to mediate cardioprotection. | ischemia | ISCHEMIA | RBCs collected from 2 groups of subjects randomized to high nitrate intake in the form of nitrate pills or nitrate-rich vegetables and 1 group subjected to low dietary intake of nitrate were given to isolated rat hearts subjected to ischemia reperfusion. The RBCs were investigated ( | PMC10471167 |
Subject terms | neuroinflammation, ALS | AMYOTROPHIC LATERAL SCLEROSIS, PATHOGENESIS | In preclinical studies rapamycin was found to target neuroinflammation, by expanding regulatory T cells, and affecting autophagy, two pillars of amyotrophic lateral sclerosis (ALS) pathogenesis. Herein we report a multicenter, randomized, double-blind trial, in 63 ALS patients who were randomly assigned in a 1:1:1 rati... | PMC10435464 |
Introduction | ALS | AMYOTROPHIC LATERAL SCLEROSIS 1, NEURODEGENERATIVE DISEASE | With a life-long risk of 1:400, Amyotrophic Lateral Sclerosis (ALS) is the 3rd most common neurodegenerative disease, holding an estimated increase of 69% in the upcoming yearsRapamycin, a drug used to prevent renal transplantation rejection, inhibits mammalian Target of Rapamycin Complex 1, leading to regulatory T lym... | PMC10435464 |
Results | PMC10435464 | |||
Participants and follow-up | ALS | From 05/10/2017 to 02/01/2020 a total of 70 patients with ALS were screened for eligibility, of whom 63 were randomly assigned to a trial group: 21 to rapamycin 2 mg/m | PMC10435464 | |
Treatment impact on blood cell subpopulations | We next examined the change from baseline to each time point (week 8, 18, 30, 54) of the activation and homing capabilities of different T, B, NK cell subpopulations, comparing treatment and placebo arms (Fig. | PMC10435464 | ||
changes from baseline in blood cells population and inflammasome across treatment arms (P = placebo, R1 = rapamycin 1 mg/m | The figure displays only a selection of the most interesting outcomes (55 cell subpopulation were examined and 11 inflammasome/cytokines, without accounting for multiple outcomes). In detail from left to right: changes from baseline to week 18 (At week 18 patients treated with rapamycin 1 mg/m | PMC10435464 | ||
Rapamycin effect on inflammasome | Patients treated with rapamycin showed lower mRNA relative expression of pro-inflammatory cytokine IL-18, which is a readout of inflammasome activation (MD −0.45, 97.5%CI −1.09 to 0.18; | PMC10435464 | ||
Longitudinal assessment of neurofilament | In the placebo arm an overall decrease in neurofilament levels was observed since the first follow-up by serial measurements in the serum (MD from baseline in serum pNfH at week 8: −174.95 ± 602.19; week 18: −289.35 ± 788.33; week 30: −482.29 ± 927.19; MD from baseline of serum NfL at week 8: −11.61 ± 96.07; week 18: −... | PMC10435464 | ||
Other biological outcome measures | Monthly changes of selected biological outcome measures during and after treatment, across arms confirmed an increase of classical monocytes/CD14+ (MD 5.42, 97.5%CI 2.19 to 8.65, | PMC10435464 | ||
Mean rates of decline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) total score (Intention to Treat population) of patients enrolled in RAP-ALS over the study (baseline to week 54) based on treatment arm allocation (red = R1, rapamycin 1 mg/m | Source data are provided as a Correlation analyses was performed on changes in ALSFRS-r and neurofilament levels to investigate whether a relation existed between clinical and biological outcomes. In the placebo arm, an inverse correlation was found between the change (week 18–baseline) in serum and CSF neurofilament l... | PMC10435464 | ||
Changes from week 18 to baseline in serum Neurofilament Light (NfL) and phosphorylated Neurofilament Heavy (pNfH) in relation to progression rate across treatment arms. | In detail from left to right, upper panels: changes from week 18 to baseline in serum pNfH in rapamycin (There were no statistically significant differences between patients treated with rapamycin and placebo as far as PEG (19.0% in the placebo group, 14.3% in the rapamycin group, A post-hoc analysis on tracheostomy-fr... | PMC10435464 | ||
Safety and drug adherence | erythema, Treatment-emergent adverse, rash, pruritus, psychiatric, headache, dermatitis, injuries, eczema | RESPIRATORY DISORDERS, ERYTHEMA, SKIN AND SUBCUTANEOUS TISSUE DISORDER, GASTROINTESTINAL DISORDERS, DISORDERS, ACUTE HEPATITIS, CONJUNCTIVITIS, EVENTS, DERMATITIS, ECZEMA | A total of 23 over 42 individuals (55%) in the rapamycin group and 11 over 21 individuals (52%) in the placebo group had one or more AEs during the trial (Table Individuals with SAEs were 19% both in the placebo and in the rapamycin groups (Table Events occurring at a greater frequency in the rapamycin group were prima... | PMC10435464 |
Drug dosage assessment | Plasma levels of rapamycin at different time points for each treatment arm are displayed in Fig. | PMC10435464 | ||
Discussion | ALSFRS-R, neuroinflammation, ALS | DISEASE PROGRESSION, CHRONIC INFLAMMATION, DISEASE, SECONDARY, EVENTS | This clinical trial measured the biological, clinical and safety effects of rapamycin on patients affected by ALS. Unfortunately, the primary outcome measure could not be satisfied also due to the reduced number of samples that could be analyzed at week 18, to which the COVID-19 pandemic significantly contributed. Notw... | PMC10435464 |
Methods | PMC10435464 | |||
Study design | ICH | MAY, APPENDIX, DEL | A randomized, double-blind, placebo-controlled trial was conducted at seven Italian ALS referral centers from 2017 through 2020. The trial was conducted in accordance with the Good Clinical Practice guidelines of the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals f... | PMC10435464 |
Trial participants | FALS, ALS | DISEASES | The trial enrolled patients diagnosed with definite, clinically probable or probable with laboratory support ALS according to revised El Escorial criteria who presented ALS symptoms onset not earlier than 18 months before screening. Inclusion criteria encompassed age between 18 and 75 years old, a forced vital capacity... | PMC10435464 |
Randomization and masking | Eligible participants were randomly assigned in three treatment arms with a 1:1:1 ratio to receive rapamycin 1 mg per square meter (m | PMC10435464 | ||
Procedures | ADVERSE EVENTS | Treatment was administered orally, in the morning, at fast. Patients received 4 bottles, each containing 15 tablets of active drug or placebo depending on the assigned treatment arm, every 2 weeks, for a planned duration of 18 weeks. Rapamycin plasma levels were regularly measured by high-performance liquid chromatogra... | PMC10435464 | |
Outcomes | death, ALS | DISEASE PROGRESSION, APPENDIX | The primary efficacy outcome was the proportion of positive response (Tregs number increase of at least 30%) at treatment end (18 weeks) with respect to baseline, in patients treated with rapamycin compared to the placebo arm. This difference was established based on a previous study demonstrating that slowly progressi... | PMC10435464 |
Statistical analysis | death, ICH, ALS, Treg%, ALSFRS-R | REGRESSION, DISEASE | Sample size was calculated using data from an Italian study showing that ALS patients have a decreased number of circulating Treg% (mean ± SD: 2.1 ± 0.7) if compared to healthy controls (2.6 ± 0.6), except for slow progressorsSafety analyses were performed including all patients who received at least one tablet of rapa... | PMC10435464 |
Reporting summary | Further information on research design is available in the | PMC10435464 | ||
Supplementary information |
Supplementary InformationPeer Review FileReporting Summary | PMC10435464 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-40734-8. | PMC10435464 | ||
Acknowledgements | NEUROMUSCULAR DISEASES | We thank all the RAP-ALS investigators group (see supplementary material). We thank the participants in the RAP-ALS trial and their families and caregivers, without whom this trial would have not been possible; Dr. Graziella Filippini, Dr. Ettore Beghi, Dr. Lawrence Korngut and Dr. Paola Minghetti, members of the data ... | PMC10435464 | |
Author contributions | SECONDARY, RECRUITMENT | J.M., A.Co., R.D.A., M.P. had the idea for the study, did the literature searches and designed the study. E.Z., I.M., N.F., G.G., C.L., F.G., C.T., L.M., F.D.M., A.S., G.S., A.F., G.L., E.D.B., C.C., G.M., A.Ch., and A.Ca. were co-investigators, were responsible for patients recruitment, treatment, biological samples c... | PMC10435464 | |
Peer review | PMC10435464 | |||
Funding | AMYOTROPHIC LATERAL SCLEROSIS | The study was supported by ARISLA (Fondazione Italiana di Ricerca per la SLA) (FGCR02/2015 to J.M.) and Pfizer Inc. (Pfizer provided the drug free of charge) (grant no. 53232941, program title: “Wi211892 Rapamycin treatment for Amyotrophic Lateral Sclerosis” to J.M.). The funders of the study were not involved in proto... | PMC10435464 | |
Data availability | The data that support the findings of this study are available from the corresponding author (jessica.mandrioli@unimore.it) to external researchers who provide methodologically sound scientific proposals and whose proposed use of the data has been approved by an independent review committee identified for this purpose.... | PMC10435464 | ||
Competing interests | J.M. reports receiving advisory board fees from Biogen, Amylix and Italfarmaco, grant support from Roche, and grant support from Pfizer (active study drug for this study by grant number Wi211892 to J.M.). ACh received consulting fees from Biogen, Cytokinetics, Amylyx. ACa reports receiving advisory board fees from Biog... | PMC10435464 | ||
References | PMC10435464 | |||
Introduction | comorbidity, fatigue, neurological disorders | TTP, NEUROLOGICAL DISORDERS | Competing interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.B vitamins play a crucial role in maintaining fundamental cellular functions and various essential metabolic pathways in the body... | PMC10542023 |
Materials and methods | PMC10542023 | |||
Vitamin B complex and placebo preparation | The supplement in this study was provided by Prince Pharmaceutical Co. Ltd. (New Taipei City, Taiwan). One vitamin B complex tablet (Ex PLUS | PMC10542023 | ||
Participants | asthma | METABOLIC DISEASE, HYPERTENSION, ASTHMA, CARDIOVASCULAR DISEASE | This study was conducted in accordance with the Declaration of Helsinki and was approved and reviewed by the Institutional Review Board of Landseed International Hospital (Taoyuan, Taiwan; LSHIRB number 20-037-A2). The trial is first registered with clinicaltrials.gov as NCT05586295 (09/12/2022). Sixteen male and sixte... | PMC10542023 |
Experimental design | fatigue | Based on previous testing periods of animal and human B-vitamin supplementation, a duration of 28 consecutive days was chosen as the supplementation period Before each phase of intervention, we measured the subjects' body composition, common blood biochemical parameters, and exercise tolerance. After consecutive 28 day... | PMC10542023 | |
Maximal oxygen uptake (VO2max) | VO | PMC10542023 | ||
Endurance performance test and exercise fatigue-related indicators | fatigue | REGRESSION | According to the heart rate and speed recorded during the maximum oxygen uptake test, a regression calculation is performed to obtain the heart rate and speed corresponding to 60% and 85% of the maximum oxygen uptake, and the speed is adjusted according to the heart rate value. The detailed formula for intensity adjust... | PMC10542023 |
Body composition | Subjects underwent body composition measurements before and after each phase of the intervention. All subjects were required to fast for 8 hours before the measurement. During the test, all subjects stood on the bottom electrode with arms extended at a 30° angle to the torso, held the induction handle with both hands, ... | PMC10542023 | ||
Clinical biochemistry and hematology analysis | high-density lipoprotein, TG | BLOOD | Blood was collected from each subject before each phase of supplementation for clinical biochemical and hematological analysis to confirm the basic biochemical indicators and health status. All the subjects were asked to fast for 8 hours the night before blood was drawn. After blood collection, the serum was obtained b... | PMC10542023 |
Statistical analysis | All data are expressed as the mean ± SD. Statistical analyses were performed in IBM SPSS Statistics ver. 24.1 (IBM Co., Armonk, NY, USA). Differences within groups before and after the intervention were analyzed using a Bonferroni-adjusted paired | PMC10542023 | ||
Results | PMC10542023 | |||
Subjects' dietary analysis and Body composition changes | fatigue | In order to ensure that subjects' exercise performance and fatigue biochemical values were not affected by differences in dietary intake and energy, 3 days dietary record analysis was performed before and after Ex PLUS | PMC10542023 | |
Effects of Ex PLUS® supplementation on biochemical parameters and hematology | Table | PMC10542023 | ||
Effects of Ex PLUS® supplementation on fatigue biochemical parameters during exercise and rest | Both lactate and NH3 levels gradually increased during exercise and gradually decreased after rest and recovery. As shown in | PMC10542023 | ||
Effects of Ex PLUS® supplementation on endurance performance | Before intervention, the exhaustion test times were 12.57 ± 2.03 and 12.59 ± 2.06 (min) for the placebo and Ex PLUS | PMC10542023 | ||
Discussion | In humans, nutrients and energy are primarily used by the body through food intake. Although the accompanying vitamins or minerals do not act as a primary energy source, they play a vital role in energy metabolism. In the current study, we found that consecutive 28 days of Ex PLUSB vitamins are involved in the regulati... | PMC10542023 | ||
Conclusions | In conclusion, in the current study, we demonstrated that 28 consecutive days of supplementation with Ex PLUSThe authors are grateful to the graduate students at the Sport Nutrition Laboratory, National Taiwan Sport University, for their technical assistance in conducting the analysis experiments. | PMC10542023 | ||
Funding | This study was supported by Prince Pharmaceutical Co. Ltd. and the Ministry of Science and Technology of Taiwan (application type: academia-industry collaboration project). The grant number is MOST-109-2622-H-179-001. | PMC10542023 | ||
Authors' contributions | Mon-Chien Lee, Sih-Yu Shen and Chi-Chang Huang designed the study. Mon-Chien Lee, Chin-Shan Ho and Chi-Chang Huang carried out the experiments. Mon-Chien Lee, Sih-Yu Shen and Chin-Shan Ho analyzed the data and interpreted the results. Mon-Chien Lee and Chi-Chang Huang wrote the manuscript.Participant flow chart.Experim... | PMC10542023 | ||
Introduction | Edited by: Ingo Drexler, Heinrich Heine University, GermanyReviewed by: Kai Wu, Moderna Inc., United States; Nawamin Pinpathomrat, Prince of Songkla University, Thailand; Gyanendra Gongal, World Health Organization - Regional Office for South-East Asia, IndiaThis article was submitted to Viral Immunology, a section of ... | PMC9886662 | ||
Methods | SARS-COV-2 INFECTION | Participants (n = 60) aged 18-60 years, naïve to SARS-CoV-2 infection or vaccination, were randomly allocated into one of four homologous or heterologous accelerated two-dose, two-injection intradermal regimens seven days apart:(1) BNT162b2-BNT162b2(n= 20),(2) ChAdOx1- BNT162b2 (n = 20), (3) CoronaVac-ChAdOx1 (n = 10),... | PMC9886662 | |
Results | ADVERSE EVENT | Immunogenicity was highest in regimen (2), followed by (1), (4), and (3) 2 weeks after the second dose (P < 0.001 for anti-RBD-IgG and P= 0.01 for PVNT50). Each group had significantly lower anti-RBD IgG (by factors of 5.4, 3.6, 11.6, and 2.0 for regimens (1) to (4), respectively) compared to their respective standard ... | PMC9886662 | |
Discussion | We concluded that accelerated, fractional, heterologous or homologous intradermal vaccination regimens of BNT162b2 and ChAdOx1 were well tolerated, provided rapid immune priming against SARS-CoV-2, and may prove useful for containing future outbreaks. | PMC9886662 | ||
Introduction | ADVERSE EVENTS | Intradermal (ID) injection, or the administration of drugs into the dermis, is an alternative method of vaccination to conventional intramuscular (IM) or subcutaneous (SC) routes (Fractional dosing also reduces reactogenicity and systemic adverse events (AEs) due to dose-dependency (Accelerated, dose-sparing approaches... | PMC9886662 | |
Material and methods | PMC9886662 | |||
Study design and participants | COA, substance abuse, allergies | DISEASES, SARS-COV-2 INFECTION, ALLERGIES | This single-center, randomized, prospective, open-labelled, pilot cohort study enrolled healthy adults aged 18-60 years during September to December of 2021. Participants naïve for SARS-CoV-2 infection, capable of adhering to scheduled fractional dosing regimens, with an ability to understand Thai, and to self-report d... | PMC9886662 |
Study procedure | -20 | Initially, 10 participants were randomly assigned into 4 groups each to receive two homologous or heterologous ID doses of CoronaVac (Sinovac), ChAdOx1 nCoV-19 (AstraZeneca), or BNT162b2 (Pfizer-BioNTech) 7 days apart. The vaccine regimens (first-second dose) for each arm were: BNT162b2-BNT162b2 (Group 1), ChAdOx1-BNT1... | PMC9886662 | |
Chemiluminescent microparticle assay for anti-SARS-CoV-2 RBD IgG and anti-NP of ancestral strain | Plasma samples were isolated using sodium citrate and stored at -80°C. A chemiluminescent microparticle assay (CMIA) was used to determine anti-RBD and anti-NP through SARS-CoV-2 IgG II Quant (Abbott Laboratory System, Illinois, US) on the ARCHITECT i System. Antibody levels were linearly measured between 21.0-40,000.0... | PMC9886662 | ||
Pseudovirus neutralization test for ancestral Wuhan strain and omicron subvariants | PVNT was carried out as described previously at the National Center of Genetic Engineering and Biotechnology, Thailand ( | PMC9886662 | ||
Cell-mediated immune response by ELISpot assay to ancestral Wuhan strain | T-cell responses were assessed using human interferon-gamma (IFN-γ) ELISpot kits according to the manufacturers’ instruction (Mabtech AB, Nacka Strand, Sweden – as previously described ( | PMC9886662 | ||
Statistical analysis | anti-SARS-CoV-2 RBD | Participants positive for anti-NP and anti-RBD at baseline were excluded from the analysis. Immunological endpoints (anti-SARS-CoV-2 RBD IgG, PVNT | PMC9886662 | |
Results | 55 participants were screened during the initial phase of the study, and 40 were enrolled. Following the preliminary analysis of this initial phase, Groups 1 and 2 induced the highest immunogenic responses (highest anti-RBD IgG). An additional 26 participants were screened, and 20 subsequently enrolled in these two gro... | PMC9886662 | ||
Anti-SARS-CoV-2 RBD IgG response to ancestral Wuhan strain | None of the participants were seropositive for anti-RBD IgG 7 days after the first dose. All were seropositive after the second dose. Anti-SARS-CoV-2 RBD IgG geometric mean concentrations (GMCs) 2 weeks after the second dose had significantly increased (SARS-CoV-2 humoral immune responses against the ancestral Wuhan st... | PMC9886662 | ||
PVNT | The PVNT | PMC9886662 | ||
Cell-mediated immune response by ELISpot to ancestral Wuhan strain | All participants, except one, had negative responses at baseline. One participant had a low ELISpot response to S-protein (24 SFU). 2 weeks after the second dose, all participants across the four regimens had significant increases in IFN-γ response against S-protein. The highest GM SFU for S-protein 2 weeks after the s... | PMC9886662 | ||
Adverse events | ADVERSE EVENTS | Many reported AEs were mild, some moderate, but none severe. All AEs fully resolved before the end of the study (see Self-reported adverse events (AEs) in days 0-7 following the first and second ID doses. | PMC9886662 | |
Discussion | infection | INFECTION, RABIES | This pilot study explored the immunogenicity and reactogenicity of accelerated schedules of fractional, homologous or heterologous, ID COVID-19 immunization. Accelerated two-dose ID regimens, administered 7 days apart, as fractions of 17% (for BNT162b2) and 20% (for CoronaVac and ChAdOx1) of their standard IM dosages w... | PMC9886662 |
Data availability statement | The original contributions presented in the study are included in the article/ | PMC9886662 | ||
Ethics statement | COA | The studies involving human participants were reviewed and approved by The Human Research Protection Unit, Faculty of Medicine Siriraj Hospital, Mahidol University (COA: MU-MOU 704/2021). The patients/participants provided their written informed consent to participate in this study. | PMC9886662 | |
Author contributions | SN and KC conceptualized the study; SN, SA, PW, KS, and KC devised the methodology; SN and KC acquired funding; SN, LJ, ZT, PL, and KC carried out the formal analysis of its findings; SN, SA, PW, KS, and KC conducted the study’s clinical investigation; SN and LJ curated the data; KKC, ZT, and KC wrote and prepared the ... | PMC9886662 | ||
Acknowledgments | We would also like to acknowledge Chevron Thailand and Health Systems Research Institute, Thailand for their support. | PMC9886662 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9886662 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9886662 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC9886662 | ||
References | PMC9886662 | |||
Background | diabetes | TYPE 1 DIABETES, DIABETES | The transition from paediatric to adult care for young adults with type 1 diabetes poses unique challenges. Virtual diabetes clinics using smartphone applications offer a promising approach to support self-management and enhance communication with healthcare providers. The primary objective of this study was to evaluat... | PMC10664359 |
Methods | diabetes | TYPE 1 DIABETES, DIABETES | 79 participants with type 1 diabetes aged 18–25 years were included in a prospective, single-centre, randomised, wait-list controlled trial. Participants were randomly assigned to either the intervention group or the wait-list control group. The intervention group received instant access to a virtual care platform call... | PMC10664359 |
Results | diabetes | DIABETES | Baseline characteristics were similar between the intervention and control groups, except for education level, where there was a skewed distribution between the groups (the intervention group had a lower education level). At the 6-month follow-up, there were no significant differences in HbA1c levels, TIR, TBR, or diab... | PMC10664359 |
Conclusions | diabetes | TYPE 1 DIABETES, DIABETES | The implementation of a virtual diabetes clinic using the Vista Dialog platform did not result in significant improvements in glycaemic control or treatment satisfaction compared with usual care. However, it did show potential benefits in terms of reducing the burden on physical health and improving quality of life in ... | PMC10664359 |
Trial registration | ISRCTN number: 73,435,627 (registration date: 23/10/2019): 10.1186/ISRCTN73435627. The performance and results of this trial adhere to the guidelines outlined in the CONSORT 2010 (Consolidated Standards of Reporting Trials) recommendations. | PMC10664359 | ||
Keywords | Open access funding provided by Uppsala University. | PMC10664359 | ||
Background | diabetes, premature death, chronic disease, Diabetes | TYPE 1 DIABETES, CHRONIC DISEASE, DIABETES, COMPLICATIONS, DIABETES | Diabetes is a chronic disease that poses a significant health risk, with potentially severe complications, including premature death [Sweden has one of the highest percentages of children with type 1 diabetes in the world [Advanced treatment technologies, such as pumps and sensors, have created additional demands regar... | PMC10664359 |
Study aim | diabetes | TYPE 1 DIABETES, DIABETES | This study aims to assess the effect of a virtual diabetes clinic on glycaemic control, treatment satisfaction, and quality of life in a specific population of young adults between the ages of 18 and 25 diagnosed with type 1 diabetes. | PMC10664359 |
Method | PMC10664359 | |||
Study design | The study design and methods of the present study have been described in detail in a previously published study protocol [
Flowchart of the trial | PMC10664359 | ||
Participants and recruitment | depression, eating disorder, diabetes | TYPE 1 DIABETES, RECRUITMENT, COMPLICATIONS, DIABETES | All participants had type 1 diabetes, were registered at a single hospital in Stockholm, Sweden, and were identified in the diabetes clinic’s patient register by hospital HCPs. The inclusion criteria of the study were access to a smartphone or computer, duration of diabetes for more than 1 year and an age of 18–25 year... | PMC10664359 |
Randomisation and intervention | The nurses at the clinic were responsible for including individuals in the study. Once informed consent was obtained from the participants, they were randomly assigned to either the intervention group or the wait-list control group. The randomization process involved the use of sealed envelopes containing randomized ca... | PMC10664359 | ||
Vista dialog | diabetes | DIABETES | Vista Dialog is a virtual care platform, managed via secure login, delivered via a smartphone app for patients and a web interface/portal for HCPs. The platform facilitates seamless real-time communication for participants, enabling them to engage in text message exchanges, schedule online appointments with diabetes sp... | PMC10664359 |
Measures and data collection | diabetes | DIABETES | Data collection for both clinical variables and psychometric measures was conducted exclusively at the diabetes clinic. Baseline assessments were carried out prior to the intervention, and outcome measurements were collected at both the baseline and 6-month follow-up time points. At baseline, comprehensive data encompa... | PMC10664359 |
Clinical variables | diabetes | DIABETES | At the standard clinic appointments, the following data were collected:
HbA1c (Afinion 2™ [Abbott, USA]) level was used to reflect the average plasma glucose level over the preceding 8–12 weeks.Time in range (TIR), the percentage of time that a person spends with their glucose levels in a targeted range (3.9–10 mmol/L)... | PMC10664359 |
Diabetes treatment satisfaction questionnaire | ’, hypoglycemia, hyperglycemia, Diabetes, diabetes | HYPERGLYCEMIA, HYPOGLYCEMIA, DIABETES, BRADLEY, DIABETES | Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs), was used to evaluate patients’ satisfaction with diabetes treatment interventions and developed and validated by Clare Bradley. This questionnaire is well-established for use in diabetes research [The DTSQs consists of three areas with a total of ei... | PMC10664359 |
Check your health questionnaire | The validated questionnaire ‘Check your health’ consists of vertical scales (0–100 points) intended to screen for perceptions and experiences of physical and emotional health, social relationships and general quality of life [ | PMC10664359 |
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