Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Type 1 Diabetes: Pilot 4T Study

2021 ◽  
Author(s):  
Priya Prahalad ◽  
Victoria Y Ding ◽  
Dessi P Zaharieva ◽  
Ananta Addala ◽  
Ramesh Johari ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glucose Monitoring ◽  
Newly Diagnosed ◽  
Tight Control ◽  
Target Setting ◽  
Multivariable Regression ◽  
Historic Cohort ◽  
Hba1c Levels ◽  
New Onset

Abstract Context Youth with type 1 diabetes (T1D) do not meet hemoglobin A1c (HbA1c) targets. Objective To assess HbA1c outcomes in children with new onset T1D enrolled in the Teamwork, Targets, Technology and Tight Control (4T) Study. Method HbA1c levels were compared between the 4T and Historical cohorts. HbA1c differences between cohorts were estimated using locally estimated scatter plot smoothing (LOESS). The change from nadir HbA1c (month 4) to 12 months post-diagnosis was estimated by cohort using a piecewise mixed effects regression model accounting for age at diagnosis, sex, ethnicity, and insurance type. Setting and Participants We recruited 135 youth with newly diagnosed T1D at Stanford Children’s Health. Intervention Starting July 2018, all youth within the first month of T1D diagnosis were offered continuous glucose monitoring (CGM) initiation and remote CGM data review was added in March 2019. Main Outcome Measure HbA1c. Results HbA1c at 6, 9, and 12 months post-diagnosis was lower in the 4T cohort than in the Historic cohort (-0.54%, -0.52%, and -0.58%, respectively). Within the 4T cohort, HbA1c at 6, 9, and 12 months post-diagnosis was lower in those patients with Remote Monitoring than those without (-0.14%, -0.18%, -0.14%, respectively). Multivariable regression analysis showed that the 4T cohort experienced a significantly lower increase in HbA1c between months 4 and 12 (p < 0.001). Conclusions A technology-enabled team-based approach to intensified new onset education involving target setting, CGM initiation, and remote data review significantly decreased HbA1c in youth with T1D 12 months post-diagnosis.

scholarly journals Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022353 ◽  
Author(s):  
Catherine Henshall ◽  
Parth Narendran ◽  
Robert C Andrews ◽  
Amanda Daley ◽  
Keith A Stokes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Type 1 Diabetes ◽  
Qualitative Study ◽  
Qualitative Methodology ◽  
Cell Function ◽  
Retention Rates ◽  
Newly Diagnosed ◽  
Advance Study ◽  
New Onset

ObjectivesRegular physical exercise may preserve β cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies.DesignQualitative methodology using individual face-to-face (n=6) and telephone interviews (n=14). Interview transcripts were thematically analysed using the framework method.SettingThe study took place at five participating UK hospitals.ParticipantsTwenty participants, aged 19–55 years, in the Exercise for Type 1 Diabetes study were interviewed to explore their study experiences and identify motivators and deterrents towards the study. Participants in control and intervention arms were interviewed, as were people with T1D who had completed (n=16) and withdrawn (n=4).ResultsParticipants revealed barriers and facilitators to retention; the majority were generalisable to clinical trials of people with newly diagnosed T1D. Coming to terms with a diagnosis of T1D, lack of time, work pressures, level of health professional support, volume, clarity and consistency of information and feedback and a desire for knowledge about their condition were all cited as influencing factors to trial retention.ConclusionsTo our knowledge, this is the first qualitative study to examine the experience of being involved in an exercise trial by people with T1D. Findings suggest appointments could be shorter, available outside of working hours and planned longer in advance; study information should be clear, consistent and in electronic and paper formats; questionnaires need minimising; healthcare support and feedback needs providing regularly; thought is required around how to support non-exercising arm participants. These considerations may improve participant retention rates in new-onset T1D studies.

CDE Perspectives of Providing New-Onset Type 1 Diabetes Education Using Formal Vignettes and Simulation

2016 ◽  
Vol 43 (1) ◽  
pp. 97-104 ◽  
Author(s):  
Neesha Ramchandani ◽  
Kim Johnson ◽  
Karen Cullen ◽  
Terri Hamm ◽  
Jean Bisordi ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetes Management ◽  
Qualitative Content Analysis ◽  
Patient Simulation ◽  
Human Patient Simulation ◽  
Newly Diagnosed ◽  
Human Patient ◽  
Diabetes Educators ◽  
New Onset

Purpose The purpose of this article is to describe the 4 Parent Education Through Simulation-Diabetes (PETS-D) nurse certified diabetes educators’ (CDEs) perspectives of teaching parents of children with newly diagnosed type 1 diabetes mellitus (T1DM) early diabetes management skills using formal vignettes and a human patient simulator/human patient simulation (HPS) to augment/enhance the teaching–learning process. Methods A qualitative descriptive approach was used. Four CDEs were interviewed by phone about their teaching experiences. Meticulous notes were taken. Data were analyzed using qualitative content analysis. Results The vignettes (and use of HPS) provided structure, especially for parents who were struggling to learn. Certified diabetes educators described a short learning curve to master the use of the HPS manikin. Human patient simulation-enhanced education was described as helpful for teaching multiple caregivers about diabetes. Certified diabetes educators also described factors that affect parent learning, mechanical issues with the HPS, and additional space requirements for HPS-enhanced education. Conclusion Vignettes and HPS-enhanced education can successfully be used to educate parents of children with new-onset T1DM and were preferred by the CDEs when compared with previous teaching strategies. The results of this study support the use of both vignette-based and HPS-enhanced education when a child is newly diagnosed with T1DM. Further studies need to be done to see if these effects persist with different populations, during different stages of the disease, and for individuals with other chronic illnesses.

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.

scholarly journals Use of factory calibrated real-time continuous glucose monitoring improves time in target and HbA1c in a multi-ethnic cohort of adolescents and young adults with type 1 diabetes: the MILLENNIAL Study

2020 ◽  
Author(s):  
Hood Thabit ◽  
Joshi Navis Prabhu ◽  
Womba Mubita ◽  
Catherine Fullwood ◽  
Shazli Azmi ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycaemic Control ◽  
Young People ◽  
Control Period ◽  
Glucose Monitoring ◽  
Random Order ◽  
Mean Difference ◽  
Time In Range ◽  
Hba1c Levels

<b>Objective: </b>International type 1 diabetes registries have shown that HbA1c levels are highest in young people with type 1 diabetes, however improving their glycaemic control remains a challenge. We propose that use of factory-calibrated Dexcom G6 CGM system would improve glycaemic control in this cohort. <p><b>Research Design and Methods: </b>We conducted a randomized crossover trial in young people with type 1 diabetes (16 – 24 years old), comparing the Dexcom G6 CGM system and self-monitoring of blood glucose (SMBG). Participants were assigned to the interventions in random order during two 8-week study periods. During SMBG, blinded CGM was worn by each participant for 10 days at the start, week-4 and week-7 of the control period. HbA1c measurements were drawn after enrolment, before and after each treatment period. The primary outcome was time in range 70–180mg/dl.</p> <p><b>Results: </b>Time in range was significantly higher during CGM compared to control [35.7±13.5% vs. 24.6±9.3%, mean difference 11.1% (95% CI 7.0 to 15.2, p<0.001)]. CGM use reduced mean sensor glucose [219.7±37.6mg/dl vs. 251.9±36.3mg/dl, mean difference -32.2mg/dl (95% CI -44.5 to -20.0, p<0.001)] and time above range [61.7±15.1% vs. 73.6±10.4%, mean difference 11.9% (95% CI -16.4 to -7.4, p<0.001)]. HbA1c level was reduced by 0.76% (95% CI -1.1 to -0.4) [-8.5mmol/mol (95% CI -12.4 to -4.6, p<0.001)]. Times spent below range (<70mg/dl and <54mg/dl) were low and comparable during both study periods. Sensor wear was 84% during the CGM period.</p> <p><b>Conclusion: </b>CGM use in young people with type 1 diabetes improves time in target and HbA1c levels compared to SMBG.<b> </b></p>

scholarly journals Cognitive Function following Diabetic Ketoacidosis in Children with New Onset or Previously Diagnosed Type 1 Diabetes

2020 ◽  
Author(s):  
Simona Ghetti ◽  
Nathan Kuppermann ◽  
Arleta Rewers ◽  
Sage R. Myers ◽  
Jeff E. Schunk ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Hemoglobin A1c ◽  
Economic Status ◽  
Digit Span ◽  
Diabetes Diagnosis ◽  
Newly Diagnosed ◽  
Neurocognitive Assessment ◽  
New Onset

<b>Objective. </b>This study assessed whether a single diabetic ketoacidosis (DKA) episode is associated with cognitive declines in children with newly diagnosed type 1 diabetes, and whether the same is true in children who had been previously diagnosed after accounting for variations in glycemic control and other relevant factors.<b> Design. </b>We prospectively enrolled 758 children, 6- to 18-years-old, who presented with DKA in a randomized multi-site clinical trial evaluating intravenous fluid protocols for DKA treatment. DKA was moderate/severe in 430 children and mild in 328 children. 392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed. Neurocognitive assessment occurred 2-6 months after the DKA episode. A comparison group of 376 children with type 1 diabetes, but no DKA exposure, was also enrolled. <b>Results. </b>Among all patients, moderate/severe DKA was associated with lower IQ (β=-.12, p<0.001), item-color recall (β=-0.08, p=0.010), and forward digit span (β=-0.06, p=0.04). Among newly diagnosed patients, moderate/severe DKA was associated with lower item-color recall (β=-0.08, p=0.04). Among previously diagnosed patients, repeated DKA exposure and higher hemoglobin A1c were independently associated with lower IQ (β=-.10 and β=-0.09, respectively, ps <.01) and higher hemoglobin A1c was associated with lower item-color recall (β=-0.10, p=0.007), after accounting for hypoglycemia, diabetes duration, and socio-economic status.<b> Conclusion. </b>A single DKA episode is associated with subtle memory declines soon after type 1 diabetes diagnosis. Sizable IQ declines are detectable in children with known diabetes, suggesting that DKA effects may be exacerbated in children with chronic exposure to hyperglycemia.<b> <br> </b>

scholarly journals High Frequency of Diabetic Ketoacidosis in Children with Newly Diagnosed Type 1 Diabetes

2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
Agnieszka Szypowska ◽  
Anna Ramotowska ◽  
Monika Grzechnik-Gryziak ◽  
Wojciech Szypowski ◽  
Anna Pasierb ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Fold Increase ◽  
Metabolic Decompensation ◽  
Newly Diagnosed ◽  
Similar Frequency ◽  
Group A ◽  
Group B ◽  
Hba1c Levels

Aim. The aim of this study was to evaluate the incidence of diabetic ketoacidosis in children and adolescents with newly diagnosed type 1 diabetes in 2006-2007 and 2013-2014.Method. The study group consisted of 426 children aged 0–18 years with type 1 diabetes onset admitted to our hospital in 2006-2007 (group A) and 2013-2014 (group B). The study comprised the analysis of medical and laboratory records from patients’ medical charts and the electronic database.Results. There was no difference between groups A and B in the percentage of children admitted with diabetic ketoacidosis (25% versus 28%, resp.,P=0.499). Among children with diabetic ketoacidosis, severe metabolic decompensation (pH < 7.1) appeared in similar frequency in groups A and B (28% versus 30%, resp.,P=0.110). In group B, children with diabetic ketoacidosis were statistically younger compared to patients without ketoacidosis(P=0.015)and had higher HbA1c levels(P=0.006). In both groups, a 2-fold increase in diabetic ketoacidosis was noted in children under the age of 3, compared to overall frequency.Conclusion. No decrease in diabetic ketoacidosis has been noted in the recent years. Although the prevalence and severity of diabetic ketoacidosis remain stable, they are unacceptably high. The youngest children are especially prone to ketoacidosis.

scholarly journals Cognitive Function following Diabetic Ketoacidosis in Children with New Onset or Previously Diagnosed Type 1 Diabetes

2020 ◽  
Author(s):  
Simona Ghetti ◽  
Nathan Kuppermann ◽  
Arleta Rewers ◽  
Sage R. Myers ◽  
Jeff E. Schunk ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Diabetic Ketoacidosis ◽  
Hemoglobin A1c ◽  
Economic Status ◽  
Digit Span ◽  
Diabetes Diagnosis ◽  
Newly Diagnosed ◽  
Neurocognitive Assessment ◽  
New Onset

<b>Objective. </b>This study assessed whether a single diabetic ketoacidosis (DKA) episode is associated with cognitive declines in children with newly diagnosed type 1 diabetes, and whether the same is true in children who had been previously diagnosed after accounting for variations in glycemic control and other relevant factors.<b> Design. </b>We prospectively enrolled 758 children, 6- to 18-years-old, who presented with DKA in a randomized multi-site clinical trial evaluating intravenous fluid protocols for DKA treatment. DKA was moderate/severe in 430 children and mild in 328 children. 392 children with DKA had new onset of type 1 diabetes, and the rest were previously diagnosed. Neurocognitive assessment occurred 2-6 months after the DKA episode. A comparison group of 376 children with type 1 diabetes, but no DKA exposure, was also enrolled. <b>Results. </b>Among all patients, moderate/severe DKA was associated with lower IQ (β=-.12, p<0.001), item-color recall (β=-0.08, p=0.010), and forward digit span (β=-0.06, p=0.04). Among newly diagnosed patients, moderate/severe DKA was associated with lower item-color recall (β=-0.08, p=0.04). Among previously diagnosed patients, repeated DKA exposure and higher hemoglobin A1c were independently associated with lower IQ (β=-.10 and β=-0.09, respectively, ps <.01) and higher hemoglobin A1c was associated with lower item-color recall (β=-0.10, p=0.007), after accounting for hypoglycemia, diabetes duration, and socio-economic status.<b> Conclusion. </b>A single DKA episode is associated with subtle memory declines soon after type 1 diabetes diagnosis. Sizable IQ declines are detectable in children with known diabetes, suggesting that DKA effects may be exacerbated in children with chronic exposure to hyperglycemia.<b> <br> </b>

scholarly journals 1020 Sleep and Glycemic Control in Adults With Long-Standing Type 1 Diabetes and Hypoglycemia Unawareness

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A387-A388
Author(s):  
S K Malone ◽  
A J Peleckis ◽  
A I Pack ◽  
N Perez ◽  
G Yu ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Sleep Onset ◽  
Glucose Monitoring ◽  
Glycemic Variability ◽  
Sleep Efficiency ◽  
Hypoglycemia Unawareness ◽  
Time In Bed ◽  
Hba1c Levels

Abstract Introduction Nocturnal hypoglycemia is life threatening for individuals with type 1 diabetes (T1D) due to loss of hypoglycemia symptom recognition (hypoglycemia unawareness) and impaired glucose counterregulation. These individuals also show disturbed sleep, which may result from glycemic dysregulation. Whether use of a hybrid closed loop (HCL) insulin delivery system with integrated continuous glucose monitoring (CGM) designed for improving glycemic control, relates to better sleep across time in this population remains unknown. Methods Six adults (median age=58y,T1D duration=41y) participated in an 18-month ongoing clinical trial assessing the effectiveness of an HCL system. Sleep and glycemic control were measured concurrently using wrist actigraphs and CGM at baseline (1 week) and months 3 and 6 (3 weeks) following HCL initiation. BMI and hemoglobin A1c (HbA1c) were collected at all timepoints. Spearman’s correlations modeled associations between sleep, BMI, and glycemic control at each time point. Repeated ANOVAs modeled sleep and glycemic control changes from baseline to 3 months and to 6 months. Results Sleep and glycemic control indices showed significant associations at baseline and 3 months. More time-in-bed and later sleep offset related to higher HbA1c levels at baseline. Later sleep onset, midpoint and offset, and greater sleep efficiency associated with greater %time with hyperglycemia (glucose &gt;180 mg/dL) or hypoglycemia (glucose &lt;70 mg/dL) at baseline and 3 months. Longer sleep duration and greater sleep efficiency related to greater %time with hyperglycemia at 3 months. At 3 months, more wake after sleep onset associated with lower HbA1c levels and longer nocturnal awakenings and more sleep fragmentation associated with less glycemic variability. While both sleep and glycemic control improved from baseline to 3 and 6 months, these were not statistically significant. Conclusion Various dimensions of actigraphic sleep related to concurrently estimated glycemic indices indicative of poorer glycemic control and HbA1c across time in adults with long-standing T1D and hypoglycemia unawareness. Support This work was supported by NIH R01DK117488 (NG), R01DK091331 (MRR), and K99NR017416 (SKM).

scholarly journals Measurement Of Peak C-Peptide At Diagnosis Informs Glycemic Control But Not Hypoglycemia In Adults With Type 1 Diabetes

2021 ◽  
Author(s):  
Alice L J Carr ◽  
Richard A Oram ◽  
Shannon M Marren ◽  
Timothy J McDonald ◽  
Parth Narendran ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Insulin Dose ◽  
Glucose Monitoring ◽  
Glycemic Variability ◽  
Newly Diagnosed ◽  
C Peptide ◽  
Glucose Levels ◽  
Normal Glucose ◽  
The Impact

Abstract Context High residual C-peptide in longer duration type 1 diabetes associates with fewer hypoglycemic events and reduced glycemic variability. Little is known about the impact of C-peptide close-to-diagnosis. Objective Using continuous glucose monitoring (CGM) data from a study of newly diagnosed adults with type 1 diabetes, we aimed to explore if variation in C-peptide close-to-diagnosis influenced glycemic variability and risk of hypoglycemia. Design We studied newly diagnosed adults with type 1 diabetes who wore a Dexcom G4 CGM for 7 days as part the EXTOD study. We examined the relationship between peak stimulated C-peptide and glycemic metrics of variability and hypoglycemia for 36 CGM traces from 23 participants. Results For every 100 pmol/l increase in peak C-peptide, percentage time spent range 3.9-10 mmol/l was increased by 2.4% [95% CI: 0.5,4.3], p=0.01) with a reduction in time spent in level 1 hyperglycemia (&gt; 10 mmol/l) and level 2 hyperglycemia (&gt; 13.9 mmol/l) by 2.6% [95% CI: -4.9, -0.4, p=0.02) and 1.3% [95% CI: -2.7, -0.006], p= 0.04) respectively. Glucose levels were on average lower by 0.19 mmol/l ([95 % CI: -0.4,0.02], p=0.06) and standard deviation reduced by 0.14 [95% CI: -0.3, -0.02], p=0.02). Hypoglycemia was not common in this group and no association was observed between time spent in hypoglycemia (p=0.97) or hypoglycemic risk (p=0.72). There was no association between peak C-peptide and insulin dose adjusted HbA1c (IDAA1c, p=0.45). Conclusions C-peptide associates with time spent in normal glucose range and with less hyperglycemia, but not risk of hypoglycemia in newly diagnosed people with type 1 diabetes.

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