A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D).
Ontology highlight
ABSTRACT:
SUBMITTER: Weissberg-Benchell J
PROVIDER: S-EPMC4969210 | biostudies-literature | 2016 Jul
REPOSITORIES: biostudies-literature
Publications
A randomized clinical trial aimed at preventing poor psychosocial and glycemic outcomes in teens with type 1 diabetes (T1D).
Weissberg-Benchell Jill J Rausch Joseph J Iturralde Esti E Jedraszko Aneta A Hood Korey K
Contemporary clinical trials 20160604
Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic contro ...[more]
Similar Datasets
Project description:Compare differences in glycated proteome between good and poorly controlled T1D human plasma
2020-01-09 | PXD015101 | Pride
Project description:ObjectiveDiabetes distress (DD) is a negative emotional response related to the burdens of living with type 1 diabetes (T1D) and is linked with diabetes outcomes, such as hemoglobin A1c (A1c). Yet, less is known about how other glycemic indicators, average blood glucose and time in range, relate to DD, and which demographic characteristics are associated with higher DD.MethodsIn total, 369 teens (Mage 15.6 ± 1.4, 51% female, MT1D duration 6.7 ± 3.8 years) screened for DD using The Problem Areas in Diabetes-Teen Version to determine eligibility for an ongoing multi-site behavioral trial. The associations of DD, demographic factors, and glycemic indicators (A1c, average blood glucose, and time in range) were analyzed.ResultsTwenty-nine percent of teens (n = 95) scored above the clinical cutoff (≥44) for DD. Females scored significantly higher on average than males. Black/African American, non-Hispanic youth screened significantly higher compared to youth from other racial/ethnic groups. Higher DD scores were related to higher A1c and average blood glucose, and lower time in range. Logistic regression models revealed that females were significantly more likely to report clinically elevated DD than males, and teens with higher A1c were 1.3 times more likely to report DD. Age and diabetes duration were not significantly associated with clinically elevated DD scores.ConclusionsResults demonstrated that DD is most prevalent in Black, non-Hispanic and female teens, and DD is associated with higher average blood glucose and lower time in range. Further investigation into these disparities is warranted to promote optimal health outcomes for teens with T1D.
| S-EPMC9801711 | biostudies-literature
Project description:Type 2 diabetes (DM2) is a disease that hinders tuberculosis (TB) control strategies worldwide. TB infection, progression, morbidity, treatment success, adverse effects, relapse, and mortality are worse in these susceptible populations. Therefore, expanding the partially known molecular mechanisms leading to TB-DM2 comorbidity may be essential to face both epidemics. Consequently, a transcriptomic study was conducted on TB-DM2 comorbidity, associated with patients with DM2 who have poor glycaemic control (PDM2), since they have a higher risk of getting TB. Human blood samples from healthy controls (CTRL, HbA1c < 6.5%), TB ( HbA1c < 6.5%), TB-DM2, DM2 (HbA1c < 8.9%), and PDM2 (HbA1c > 10%) groups (n=4 each) were analyzed using high-density human GE 4X44K v2 differential expression microarrays.
2024-06-04 | GSE249102 | GEO
Project description:Objective:Impairments in executive function (EF) skills have been observed in youth with type 1 diabetes (T1D), and these skills are critical for following the complex treatment regimen. This study examines parent reports of EF in relation to measures of adherence, glycemic control (A1c), and psychosocial outcomes (depression and quality of life) in adolescents with T1D. A total of 120 adolescents (aged 13-17 years, 52.5% female, 87.5% White) with T1D and their parents completed questionnaires. Glucometers were downloaded and A1c was obtained during clinical visits at the time of enrollment. The prevalence of clinically significant elevated scores on specific EF skills ranged from 11 to 18.6%. In multivariate analyses, parent-reported EF deficits were associated with poorer adherence and lower quality of life, explaining 13 and 12% of the variance, respectively. Adolescents with T1D exhibit specific EF deficits that may negatively impact their quality of life and their ability to engage in self-management activities.
| S-EPMC5896612 | biostudies-literature
Project description:ImportanceHybrid closed-loop (HCL) therapy has improved glycemic control in children and adolescents with type 1 diabetes; however, the efficacy of HCL on glycemic and psychosocial outcomes has not yet been established in a long-term randomized clinical trial.ObjectiveTo determine the percentage of time spent in the target glucose range using HCL vs current conventional therapies of continuous subcutaneous insulin infusion or multiple daily insulin injections with or without continuous glucose monitoring (CGM).Design, setting, and participantsThis 6-month, multicenter, randomized clinical trial included 172 children and adolescents with type 1 diabetes; patients were recruited between April 18, 2017, and October 4, 2019, in Australia. Data were analyzed from July 25, 2020, to February 26, 2021.InterventionsEligible participants were randomly assigned to either the control group for conventional therapy (continuous subcutaneous insulin infusion or multiple daily insulin injections with or without CGM) or the intervention group for HCL therapy.Main outcomes and measuresThe primary outcome was the percentage of time in range (TIR) within a glucose range of 70 to 180 mg/dL, measured by 3-week masked CGM collected at the end of the study in both groups. Secondary outcomes included CGM metrics for hypoglycemia, hyperglycemia, and glycemic variability and psychosocial measures collected by validated questionnaires.ResultsA total of 135 patients (mean [SD] age, 15.3 [3.1] years; 76 girls [56%]) were included, with 68 randomized to the control group and 67 to the HCL group. Patients had a mean (SD) diabetes duration of 7.7 (4.3) years and mean hemoglobin A1c of 64 (11) mmol/mol, with 110 participants (81%) receiving continuous subcutaneous insulin infusion and 72 (53%) receiving CGM. In the intention-to-treat analyses, TIR increased from a mean (SD) of 53.1% (13.0%) at baseline to 62.5% (12.0%) at the end of the study in the HCL group and from 54.6% (12.5%) to 56.1% (12.2%) in the control group, with a mean adjusted difference between the 2 groups of 6.7% (95% CI, 2.7%-10.8%; P = .002). Hybrid closed-loop therapy also reduced the time that patients spent in a hypoglycemic (<70 mg/dL) range (difference, -1.9%; 95% CI, -2.5% to -1.3%) and improved glycemic variability (coefficient of variation difference, -5.7%; 95% CI, -10.2% to -0.9%). Hybrid closed-loop therapy was associated with improved diabetes-specific quality of life (difference, 4.4 points; 95% CI, 0.4-8.4 points), with no change in diabetes distress. There were no episodes of severe hypoglycemia or diabetic ketoacidosis in either group.Conclusions and relevanceIn this randomized clinical trial, 6 months of HCL therapy significantly improved glycemic control and quality of life compared with conventional therapy in children and adolescents with type 1 diabetes.Trial registrationANZCTR identifier: ACTRN12616000753459.
| S-EPMC8506294 | biostudies-literature
Project description:BackgroundTeens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep represents a novel target to improve outcomes in teens.ObjectiveTo evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention in teens with T1D.Research design and methodsTeens aged 13 to 17 with T1D (n = 39) completed measures of sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep. Hemoglobin A1C (HbA1c) was collected from medical records. Teens were randomized to Usual Care (n = 19) or the Sleep Coach intervention (n = 20). Teens in the Sleep Coach group received educational materials on healthy sleep habits and completed three individual telephone sessions. Follow-up data were collected at 3 months, including exit interviews with teens and parents.ResultsFeasibility of the study was excellent; 80% of teens in the Sleep Coach group completed all three sessions, and retention was high (90%). Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48-minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants. No change in HbA1c was observed.ConclusionsThe Sleep Coach intervention for teens with T1D is a feasible and acceptable program that increased sleep duration and improved sleep quality for this high-risk population.
| S-EPMC7670490 | biostudies-literature
Project description:BackgroundThe comparative effectiveness of glucose-lowering medications for use with metformin to maintain target glycated hemoglobin levels in persons with type 2 diabetes is uncertain.MethodsIn this trial involving participants with type 2 diabetes of less than 10 years' duration who were receiving metformin and had glycated hemoglobin levels of 6.8 to 8.5%, we compared the effectiveness of four commonly used glucose-lowering medications. We randomly assigned participants to receive insulin glargine U-100 (hereafter, glargine), the sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or sitagliptin, a dipeptidyl peptidase 4 inhibitor. The primary metabolic outcome was a glycated hemoglobin level, measured quarterly, of 7.0% or higher that was subsequently confirmed, and the secondary metabolic outcome was a confirmed glycated hemoglobin level greater than 7.5%.ResultsA total of 5047 participants (19.8% Black and 18.6% Hispanic or Latinx) who had received metformin for type 2 diabetes were followed for a mean of 5.0 years. The cumulative incidence of a glycated hemoglobin level of 7.0% or higher (the primary metabolic outcome) differed significantly among the four groups (P<0.001 for a global test of differences across groups); the rates with glargine (26.5 per 100 participant-years) and liraglutide (26.1) were similar and lower than those with glimepiride (30.4) and sitagliptin (38.1). The differences among the groups with respect to a glycated hemoglobin level greater than 7.5% (the secondary outcome) paralleled those of the primary outcome. There were no material differences with respect to the primary outcome across prespecified subgroups defined according to sex, age, or race or ethnic group; however, among participants with higher baseline glycated hemoglobin levels there appeared to be an even greater benefit with glargine, liraglutide, and glimepiride than with sitagliptin. Severe hypoglycemia was rare but significantly more frequent with glimepiride (in 2.2% of the participants) than with glargine (1.3%), liraglutide (1.0%), or sitagliptin (0.7%). Participants who received liraglutide reported more frequent gastrointestinal side effects and lost more weight than those in the other treatment groups.ConclusionsAll four medications, when added to metformin, decreased glycated hemoglobin levels. However, glargine and liraglutide were significantly, albeit modestly, more effective in achieving and maintaining target glycated hemoglobin levels. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; GRADE ClinicalTrials.gov number, NCT01794143.).
| S-EPMC9829320 | biostudies-literature
Project description:ObjectiveLimited information is available about glycemic outcomes with a closed-loop control (CLC) system compared with a predictive low-glucose suspend (PLGS) system.Research design and methodsAfter 6 months of use of a CLC system in a randomized trial, 109 participants with type 1 diabetes (age range, 14-72 years; mean HbA1c, 7.1% [54 mmol/mol]) were randomly assigned to CLC (N = 54, Control-IQ) or PLGS (N = 55, Basal-IQ) groups for 3 months. The primary outcome was continuous glucose monitor (CGM)-measured time in range (TIR) for 70-180 mg/dL. Baseline CGM metrics were computed from the last 3 months of the preceding study.ResultsAll 109 participants completed the study. Mean ± SD TIR was 71.1 ± 11.2% at baseline and 67.6 ± 12.6% using intention-to-treat analysis (69.1 ± 12.2% using per-protocol analysis excluding periods of study-wide suspension of device use) over 13 weeks on CLC vs. 70.0 ± 13.6% and 60.4 ± 17.1% on PLGS (difference = 5.9%; 95% CI 3.6%, 8.3%; P < 0.001). Time >180 mg/dL was lower in the CLC group than PLGS group (difference = -6.0%; 95% CI -8.4%, -3.7%; P < 0.001) while time <54 mg/dL was similar (0.04%; 95% CI -0.05%, 0.13%; P = 0.41). HbA1c after 13 weeks was lower on CLC than PLGS (7.2% [55 mmol/mol] vs. 7.5% [56 mmol/mol], difference -0.34% [-3.7 mmol/mol]; 95% CI -0.57% [-6.2 mmol/mol], -0.11% [1.2 mmol/mol]; P = 0.0035).ConclusionsFollowing 6 months of CLC, switching to PLGS reduced TIR and increased HbA1c toward their pre-CLC values, while hypoglycemia remained similarly reduced with both CLC and PLGS.
| S-EPMC7372060 | biostudies-literature
Project description:ImportanceYouth-onset type 2 diabetes is associated with poor glycemic control and early onset of complications. Identification of psychosocial factors associated with poor glycemic control is needed to inform efficacious interventions.ObjectiveTo identify psychosocial factors associated with glycated hemoglobin (HbA1c) levels in young adults with youth-onset type 2 diabetes.Design, setting, and participantsFor the iCount cohort study, HbA1c levels were measured twice (at baseline [T1] and at 1 year [T2]) during the last years (2017-2019) of the observational phase of the multicenter Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY2) study. Participants were young adults who had been diagnosed with type 2 diabetes during childhood or adolescence. Data were analyzed from December 2021 to September 2023.Main outcomes and measuresGlycemic control was examined categorically (high [≥8.0%] vs low [<8.0%] HbA1c), continuously (HbA1c level), and over time (change in HbA1c: decreased ≥0.5%, remained stable, or increased ≥0.5%). Psychosocial measures included beliefs about medicines, depression and anxiety symptoms, diabetes distress, diabetes self-efficacy, self-management support, and unmet material needs. Multivariable logistic and linear regression models evaluated the association of each psychosocial factor with the probability of T2 HbA1c of 8.0% or greater, T2 HbA1c level, and change in HbA1c.ResultsOf the 411 TODAY2 participants approached, 381 enrolled in the iCount study, and 348 with T1 and T2 HbA1c data comprised the analysis group. The 348 participants had a mean (SD) age of 26.1 (2.5) years and a mean (SD) HbA1c of 9.4% (2.8%). Most participants (229 [65.8%]) were women. In adjusted multivariable regressions, greater beliefs that diabetes medicines are necessary (odds ratio [OR], 1.19 [95% CI, 1.03-1.37]; P = .02), concerns about medicines (OR, 1.20 [95% CI, 1.00-1.45]; P = .049), diabetes distress (OR, 1.08 [95% CI, 1.02-1.15]; P = .006), and high distress (OR, 2.18 [95% CI, 1.15-4.13]; P = .02) increased the odds of high HbA1c at T2. Greater support (OR, 0.67 [95% CI, 0.46-0.97]; P = .04) and diabetes self-efficacy (OR, 0.91 [95% CI, 0.84-0.99]; P = .02) decreased the odds of high HbA1c at T2. Diabetes distress was associated with higher HbA1c level at T2 (coefficient, 0.08 [95% CI, 0.02-0.13]; P = .01). Beliefs that diabetes medicines are necessary (OR, 1.20 [95% CI, 1.03-1.39]; P = .02) and concerns about medicines (OR, 1.22 [95% CI, 1.00-1.47]; P = .048) increased the odds of an HbA1c decrease of at least 0.5% over 1 year.Conclusions and relevanceIn this cohort study of young adults with youth-onset type 2 diabetes, beliefs about medicines, high diabetes distress, low diabetes self-efficacy, and self-management support were associated with high HbA1c over time. Future research should assess whether interventions that address these factors result in improved glycemic control in this at-risk group.
| S-EPMC11002701 | biostudies-literature
Project description:SPECIFIC AIM: Although the Department of Veterans Affairs (VA) has made significant organizational changes to improve diabetes care, diabetes self-management has received limited attention. The purpose of this study is to assess factors influencing diabetes self-management among veterans with poorly controlled diabetes. METHODS: Surveys were mailed to patients with type 2 diabetes and a HbA1c of 8% or greater who attended 1 of 2 VA Medical Centers in Washington State (n = 1,286). Validated survey instruments assessed readiness to change, self-efficacy, provider advice, and diabetes self-care practices. RESULTS: Our response rate was 56% (n = 717). Most respondents reported appropriate advice from physicians regarding physical activity, nutrition, and glucose monitoring (73%, 92%, and 98%, respectively), but many were not ready to change self-management behaviors. Forty-five percent reported non-adherence to medications, 42% ate a high-fat diet, and only 28% obtained either moderate or vigorous physical activity. The mean self-efficacy score for diabetes self-care was low and half of the sample reported readiness to change nutrition (52%) or physical activity (51%). Individuals with higher self-efficacy scores were more likely to adhere to medications, follow a diabetic meal plan, eat a lower fat diet, have higher levels of physical activity, and monitor their blood sugars (P < .001 for all). CONCLUSIONS: Although veterans with poor diabetes control receive appropriate medical advice, many were not sufficiently confident or motivated to make and maintain self-management changes. Targeted patient-centered interventions may need to emphasize increasing self-efficacy and readiness to change to further improve VA diabetes outcomes.
| S-EPMC1829424 | biostudies-other