scholarly journals Ergocalciferol in New-onset Type 1 diabetes: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Benjamin Udoka Nwosu ◽  
Sadichchha Parajuli ◽  
Gabrielle Jasmin ◽  
Jody Fleshman ◽  
Rohit B Sharma ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Temporal Trends ◽  
Treatment Protocol ◽  
Total Daily Dose ◽  
Control Group ◽  
Newly Diagnosed ◽  
Tnf Α ◽  
The Impact

Abstract Background The impact of the anti-inflammatory and immunomodulatory actions of Vitamin D on the duration of partial clinical remission (PR) in youth with type 1 diabetes (T1D) is unclear. Objective To determine the effect of adjunctive ergocalciferol on residual β-cell function (RBCF) and PR in youth with newly-diagnosed T1D who were maintained on a standardized insulin treatment protocol. Hypothesis Ergocalciferol supplementation increases RBCF and prolongs PR. Methods A 12-month randomized, double-blind, placebo-controlled trial of 50,000 IU of ergocalciferol per week for 2 months, and then once every 2 weeks for 10 months, versus placebo in 36 subjects of ages 10-21years(y), with T1D of <3 months, and a stimulated C-peptide (SCP) level of ≥0.2nmol/L (≥0.6ng/mL). The ergocalciferol group had 18 randomized subjects (10m/ 8f), mean age 13.3±2.8y; while the control group had 18 subjects (14m/4f), age 14.3±2.9y. Results The ergocalciferol treatment group had significantly higher serum 25-hydroxyvitamin D at 6 months (p=0.01) and 9 months (p=0.02) than the placebo group. At 12 months, the ergocalciferol group had a significantly lower serum TNF-α concentration (p=0.03). There were no significant differences between the groups at each timepoint from baseline to 12 months for SCP concentration (p=0.08), HbA1c (p=0.09), insulin-dose-adjusted A1c (IDAA1c), or total daily dose of insulin. Temporal trends for rising HbA1c (p=0.044) and IDAA1c (p=0.015) were significantly blunted in the ergocalciferol group. Conclusions Ergocalciferol significantly reduced serum TNF-α concentration and the rates of increase in both A1c and IDAA1c suggesting a protection of RBCF and PR in youth with newly-diagnosed T1D.

scholarly journals Autonomous and Continuous Adaptation of a Bihormonal Bionic Pancreas in Adults and Adolescents With Type 1 Diabetes

2014 ◽  
Vol 99 (5) ◽  
pp. 1701-1711 ◽  
Author(s):  
Firas H. El-Khatib ◽  
Steven J. Russell ◽  
Kendra L. Magyar ◽  
Manasi Sinha ◽  
Katherine McKeon ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Insulin Dose ◽  
Total Daily Dose ◽  
Insulin Requirements ◽  
Daily Insulin Dose ◽  
And Shifts ◽  
The Impact

Context: A challenge for automated glycemic control in type 1 diabetes (T1D) is the large variation in insulin needs between individuals and within individuals at different times in their lives. Objectives: The objectives of the study was to test the ability of a third-generation bihormonal bionic pancreas algorithm, initialized with only subject weight; to adapt automatically to the different insulin needs of adults and adolescents; and to evaluate the impact of optional, automatically adaptive meal-priming boluses. Design: This was a randomized controlled trial. Setting: The study was conducted at an inpatient clinical research center. Patients: Twelve adults and 12 adolescents with T1D participated in the study. Interventions: Subjects in each age group were randomized to automated glycemic control for 48 hours with or without automatically adaptive meal-priming boluses. Main Outcome Measures: Mean plasma glucose (PG), time with PG less than 60 mg/dL, and insulin total daily dose were measured. Results: The 48-hour mean PG values with and without adaptive meal-priming boluses were 132 ± 9 vs 146 ± 9 mg/dL (P = .03) in adults and 162 ± 6 vs 175 ± 9 mg/dL (P = .01) in adolescents. Adaptive meal-priming boluses improved mean PG without increasing time spent with PG less than 60 mg/dL: 1.4% vs 2.3% (P = .6) in adults and 0.1% vs 0.1% (P = 1.0) in adolescents. Large increases in adaptive meal-priming boluses and shifts in the timing and size of automatic insulin doses occurred in adolescents. Much less adaptation occurred in adults. There was nearly a 4-fold variation in the total daily insulin dose across all cohorts (0.36–1.41 U/kg · d). Conclusions: A single control algorithm, initialized only with subject weight, can quickly adapt to regulate glycemia in patients with TID and highly variable insulin requirements.

scholarly journals Circulating Levels of MicroRNA from Children with Newly Diagnosed Type 1 Diabetes and Healthy Controls: Evidence That miR-25 Associates to Residual Beta-Cell Function and Glycaemic Control during Disease Progression

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Lotte B. Nielsen ◽  
Cheng Wang ◽  
Kaspar Sørensen ◽  
Claus H. Bang-Berthelsen ◽  
Lars Hansen ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycaemic Control ◽  
Beta Cell ◽  
Beta Cell Function ◽  
Cell Function ◽  
Control Group ◽  
Healthy Controls ◽  
Newly Diagnosed ◽  
New Onset

This study aims to identify key miRNAs in circulation, which predict ongoing beta-cell destruction and regeneration in children with newly diagnosed Type 1 Diabetes (T1D). We compared expression level of sera miRNAs from new onset T1D children and age-matched healthy controls and related the miRNAs expression levels to beta-cell function and glycaemic control. Global miRNA sequencing analyses were performed on sera pools from two T1D cohorts (n= 275 and 129, resp.) and one control group (n= 151). We identified twelve upregulated human miRNAs in T1D patients (miR-152, miR-30a-5p, miR-181a, miR-24, miR-148a, miR-210, miR-27a, miR-29a, miR-26a, miR-27b, miR-25, miR-200a); several of these miRNAs were linked to apoptosis and beta-cell networks. Furthermore, we identified miR-25 as negatively associated with residual beta-cell function (est.: −0.12,P= 0.0037), and positively associated with glycaemic control (HbA1c) (est.: 0.11,P= 0.0035) 3 months after onset. In conclusion this study demonstrates that miR-25 might be a “tissue-specific” miRNA for glycaemic control 3 months after diagnosis in new onset T1D children and therefore supports the role of circulating miRNAs as predictive biomarkers for tissue physiopathology and potential intervention targets.

Home Telemedicine (CoYoT1 Clinic): A Novel Approach to Improve Psychosocial Outcomes in Young Adults With Diabetes

2019 ◽  
Vol 45 (4) ◽  
pp. 420-430 ◽  
Author(s):  
Marwan Bakhach ◽  
Mark W. Reid ◽  
Elizabeth A. Pyatak ◽  
Cari Berget ◽  
Cindy Cain ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Young Adults ◽  
Self Efficacy ◽  
Group Home ◽  
Depression Scale ◽  
Diabetes Distress ◽  
Control Group ◽  
Distress Scale ◽  
The Impact

Purpose To assess the impact of a home telemedicine clinic model (CoYoT1 Clinic) on psychosocial and behavioral outcomes designed for young adults (YAs) with type 1 diabetes (T1D). Methods YAs self-selected to participate in the CoYoT1 Clinic or serve as a usual care control. CoYoT1 Clinic visits consisted of an individual appointment with a provider and a group appointment with other YAs with T1D using home telemedicine. Psychosocial and behavioral functioning was assessed by 4 measures: Diabetes Distress Scale, Self-Efficacy for Diabetes Scale, Self-Management of Type 1 Diabetes in Adolescence Scale, and Center for Epidemiologic Studies Depression Scale. Results Forty-two patients participated in the CoYoT1 Clinic and 39 patients served as controls. CoYoT1 participants reported lower levels of distress ( P = .03), increased diabetes self-efficacy ( P = .01), and improved ability to communicate with others about diabetes ( P = .04) over the study period compared to controls. YA males in the control group reported increases in depressive symptoms ( P = .03) during the study period, but CoYoT1 participants showed no changes. Conclusion Group home telemedicine for YAs with T1D positively affects diabetes distress, self-efficacy, and diabetes-specific communication. These positive findings have the potential to also affect the YAs’ long-term diabetes outcomes. Further investigation of the model is needed.

scholarly journals Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e036496 ◽  
Author(s):  
Anna Lena Brorsson ◽  
Ewa-Lena Bratt ◽  
Philip Moons ◽  
Anna Ek ◽  
Elisabeth Jelleryd ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Chronic Conditions ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ethical Review ◽  
Control Group ◽  
Randomised Controlled

IntroductionAdolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complications. There is a lack of evidence regarding the effectiveness of transition programmes. As a part of the Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS research programme, the objective of this study is to evaluate the effectiveness and experiences of different transitional care models, including a person-centred transition programme aiming to empower adolescents with T1D to become active partners in their health and care.Methods and analysisIn this randomised controlled trial, patients are recruited from two paediatric diabetes clinics at the age of 16 years. Patients are randomly assigned to either the intervention group (n=70) where they will receive usual care plus the structured transition programme, or to the control group (n=70) where they will only receive usual care. Data will be collected at 16, 17 and 18.5 years of age. In a later stage, the intervention group will be compared with adolescents in a dedicated youth clinic in a third setting. The primary outcome is patient empowerment. Secondary outcomes include generic, diabetes-specific and transfer-specific variables.Ethics and disseminationThe study has been approved by the Ethical Review Board in Stockholm (Dnr 2018/1725-31). Findings will be reported following the Consolidated Standards of Reporting Trials statement and disseminated in peer-reviewed journals and at international conferences.Trial registration numberNCT03994536

scholarly journals COVID-19 Pandemic and Pediatric Type 1 Diabetes: No Significant Change in Glycemic Control During The Pandemic Lockdown of 2020

2021 ◽  
Vol 12 ◽  
Author(s):  
Benjamin Udoka Nwosu ◽  
Layana Al-Halbouni ◽  
Sadichchha Parajuli ◽  
Gabrielle Jasmin ◽  
Emily Zitek-Morrison ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Insulin Pump ◽  
Point Of Care ◽  
Clinic Visit ◽  
Total Daily Dose ◽  
Significant Change ◽  
Us Children ◽  
The Impact

ImportanceThere is no consensus on the impact of the 2020 COVID-19 pandemic lockdown on glycemic control in children and adolescents with type 1 diabetes (T1D) in the US.AimTo determine the impact of the pandemic lockdown of March 15th through July 6th, 2020 on glycemic control after controlling for confounders.Subjects and MethodsAn observational study of 110 subjects of mean age 14.8 ± 4.9 years(y), [male 15.4 ± 4.0y, (n=57); female 14.1 ± 3.8y, (n=53), p=0.07] with T1D of 6.31 ± 4.3y (95% CI 1.0-19.7y). Data were collected at 1-4 months before the lockdown and 1-4 months following the lifting of the lockdown at their first post-lockdown clinic visit.ResultsThere was no significant change in A1c between the pre- and post-pandemic lockdown periods, 0.18 ± 1.2%, (95% CI -0.05 to 0.41), p=0.13. There were equally no significant differences in A1c between the male and female subjects, -0.16 ± 1.2 vs -0.19 ± 1.2%, p=0.8; insulin pump users and non-pump users, -0.25 ± 1.0 vs -0.12 ± 1.4%, p=0.5; and pubertal vs prepubertal subjects, 0.18 ± 1.3 vs -0.11 ± 0.3%, p=0.6. The significant predictors of decrease in A1c were pre-lockdown A1c (p<0.0001) and the use of CGM (p=0.019). The CGM users had significant reductions in point-of-care A1c (0.4 ± 0.6%, p=0.0012), the CGM-estimated A1c (p=0.0076), mean glucose concentration (p=0.022), a significant increase in sensor usage (p=0.012), with no change in total daily dose of insulin (TDDI). The non-CGM users had significantly increased TDDI (p<0.0001) but no change in HbA1c, 0.06 ± 1.8%, p=0.86.ConclusionsThere was no change in glycemic control during the pandemic lockdown of 2020 in US children.

scholarly journals A multi-centre service evaluation of the impact of the COVID-19 pandemic on presentation of newly diagnosed cancers and type 1 diabetes in children in the UK

2021 ◽  
Author(s):  
◽  
Gemma Williams ◽  
Ross McLean ◽  
Jo-Fen Liu ◽  
Timothy Ritzmann ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Disease Severity ◽  
Delayed Diagnosis ◽  
Service Evaluation ◽  
Newly Diagnosed ◽  
Children And Families ◽  
The Uk ◽  
The Impact ◽  
Diagnostic Intervals

AbstractBackgroundThe COVID-19 pandemic led to changes in patterns of presentation to Emergency Departments (ED). Child health professionals were concerned that this could contribute to the delayed diagnosis of life-threatening conditions, including childhood cancer (CC) and type 1 diabetes (T1DM). Our multicentre, UK-based service evaluation assessed diagnostic intervals and disease severity for these conditions.MethodsWe collected presentation route, timing and disease severity for children with newly diagnosed CC in three principal treatment centres, and T1DM in four centres between 1stJanuary – 31st July 2020 and the corresponding period in 2019. We assessed the impact of lockdown on total diagnostic interval (TDI), patient interval (PI), system interval (SI) and disease severity.FindingsFor CCs and T1DM, the route to diagnosis and severity of illness at presentation were unchanged across all time periods. Diagnostic intervals for CCs during lockdown were comparable to that in 2019 (TDI 4.6, PI 1.1 and SI 2.1 weeks), except for an increased PI in Jan-Mar 2020 (median 2.7 weeks). Diagnostic intervals for T1DM during lockdown were similar to that in 2019 (TDI 16 vs 15 and PI 14 vs 14 days), except for an increased PI in Jan-Mar 2020 (median 21 days).InterpretationThere is no evidence of diagnostic delay or increased illness severity for CC or T1DM, during the first phase of the pandemic across the participating centres. This provides reassuring data for children and families with these life-changing conditions.Research in ContextEvidence before this studyThis project was initiated after the first national lockdown in March 2020 during COVID-19 pandemic in the UK. At the design stage, Medline was searched (with no language limit), using the keywords ((Cancer) OR (neoplasm) OR (Type 1 diabetes mellitus)) AND ((Covid-19) OR (SARS-CoV-2) OR (Pandemics)) AND ((Emergency department attendances) OR (diabetes ketoacidosis) OR (Delayed diagnosis) OR (interval) OR (wait)) to identify publications reporting the impact of the pandemic and public health measures on both overall and paediatric healthcare services. Significant changes in service utilisation in the UK were reported following the commencement of the first lockdown, including a 49% reduction in emergency department attendances in the week following the lockdown; and two adult studies reported that referral via the urgent two-week wait cancer referral diagnoses decreased by 84% from Mar-May and 60% in June 2020. As for Type 1 diabetes (T1DM), a 30 patient UK-study reported an increase in newly diagnosed T1DM during the first six weeks of lockdown. Increased proportions of severe diabetic ketoacidosis (DKA) at presentation were also reported in an Italian survey involving 53 paediatric diabetes centres. Through the search we identified a need for multi-centre, more thorough assessment on referral pathways, time taken from symptom onset to diagnosis, and its association with severity at presentation for children diagnosed with life-changing conditions during the national lockdown.Added value of this studyOur findings suggest that the first national lockdown in the UK were not associated with delayed diagnosis of childhood cancer or type 1 diabetes at participating centres. This provides reassuring information for children and families with these life-changing conditions.ImplicationWe believe that our study can play a key role in allaying parental and professional concern. it is important to establish whether subsequent public health measures have impacted the diagnostic interval in the context of an evolving backlog of patient referrals across the UK.

scholarly journals Text message reminders for adolescents with poorly controlled type 1 diabetes: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248549
Author(s):  
Nour Ibrahim ◽  
Jean-Marc Treluyer ◽  
Nelly Briand ◽  
Cécile Godot ◽  
Michel Polak ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Hba1c Level ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Baseline Hba1c ◽  
Randomized Controlled ◽  
Intent To Treat ◽  
Treat Analysis

Background Among adolescents with type 1 diabetes, some experience great difficulties with treatment adherence, putting them at high risk of complications. We assessed the effect of text messaging (Short Messaging Service [SMS]) on glycemic control. Methods A two-arm open label randomized controlled trial enrolled adolescents with type 1 diabetes aged 12–21 years with baseline HbA1c ≥ 69 mmol/mol (8.5%). The intervention group received daily SMS reminders at self-selected times about insulin injections while the control group received standard of care. The patients allocated to the control group were not aware of the intervention. Results 92 patients were randomized, 45 in the SMS arm and 47 in the control arm. After 6 months, median HbA1c level was significantly lower in the intervention arm: 73 mmol/mol (8.8%) in the SMS arm and 83 mmol/mol (9.7%) in the control arm in the intent-to-treat analysis (P = 0.03) but no longer in the per protocol analysis (P = 0.65). When we consider the proportions of patients whose HbA1c level decreased by at least 1% between baseline and 6 months, we find a significant difference among patients whose baseline HbA1c was ≥ 80 mmol/mol (9.5%) (n = 56): 60% in the SMS arm and 30.6% in the control arm had lowered their HbA1c level (P = 0.03) in the intent-to-treat analysis but not in the per-protocol analysis (P = 0.50). Patients in the SMS arm reported high satisfaction with the intervention. Conclusions While there is a trend to lower HbA1c in the intervention group, no firm conclusions can yet be drawn. Further studies are needed to address methodological issues as we believe these interventions can support behavior change among adolescents with poorly controlled type 1 diabetes. ClinicalTrials.gov identifier: NCT02230137.

scholarly journals Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc): protocol for a group randomised controlled trial of a novel intervention addressing cognitions

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e030356 ◽  
Author(s):  
Stephanie A Amiel ◽  
Pratik Choudhary ◽  
Peter Jacob ◽  
Emma Lauretta Smith ◽  
Nicole De Zoysa ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Glucose ◽  
Technology Use ◽  
Emergency Services ◽  
Controlled Trial ◽  
Self Care ◽  
Clinical Effectiveness ◽  
The Impact ◽  
Hypoglycaemia Awareness

IntroductionSevere hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence.Methods and analysisA randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol.Ethics and disseminationThe protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups.Trial registration numberNCY02940873; Pre-results.

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