To identify factors that predict medication adherence and to examine relationships among adherence, glycemic control, and indices of insulin action in TODAY (Treatment Options for Type 2 Diabetes in ...Adolescents and Youth).
A total of 699 youth 10-17 years old with recent-onset type 2 diabetes and ≥80% adherence to metformin therapy for ≥8 weeks during a run-in period were randomized to receive one of three treatments. Participants took two study pills twice daily. Adherence was calculated by pill count from blister packs returned at visits. High adherence was defined as taking ≥80% of medication; low adherence was defined as taking <80% of medication. Depressive symptoms, insulin sensitivity (1/fasting insulin), insulinogenic index, and oral disposition index (oDI) were measured. Survival analysis examined the relationship between medication adherence and loss of glycemic control. Generalized linear mixed models analyzed trends in adherence over time.
In this low socioeconomic cohort, high and low adherence did not differ by sex, age, family income, parental education, or treatment group. Adherence declined over time (72% high adherence at 2 months, 56% adherence at 48 months, P < 0.0001). A greater percentage of participants with low adherence had clinically significant depressive symptoms at baseline (18% vs. 12%, P = 0.0415). No adherence threshold predicted the loss of glycemic control. Longitudinally, participants with high adherence had significantly greater insulin sensitivity and oDI than those with low adherence.
In the cohort, the presence of baseline clinically significant depressive symptoms was associated with subsequent lower adherence. Medication adherence was positively associated with insulin sensitivity and oDI, but, because of disease progression, adherence did not predict long-term treatment success.
Our primary aim was to evaluate the effects of 2 family-based obesity management interventions compared with a control group on BMI in low-income adolescents with overweight or obesity.
In this ...randomized clinical trial, 360 urban-residing youth and a parent were randomly assigned to 1 of 2 behaviorally distinct family interventions or an education-only control group. Eligible children were entering the sixth grade with a BMI ≥85th percentile. Interventions were 3 years in length; data were collected annually for 3 years. Effects of the interventions on BMI slope (primary outcome) over 3 years and a set of secondary outcomes were assessed.
Participants were primarily African American (77%), had a family income of <25 000 per year, and obese at enrollment (68%). BMI increased over time in all study groups, with group increases ranging from 0.95 to 1.08. In an intent-to-treat analysis, no significant differences were found in adjusted BMI slopes between either of the family-based interventions and the control group (
= .35). No differences were found between the experimental and control groups on secondary outcomes of diet, physical activity, sleep, perceived stress, or cardiometabolic factors. No evidence of effect modification of the study arms by sex, race and/or ethnicity, household income, baseline levels of child and parent obesity, or exposure to a school fitness program were found.
In this low-income, adolescent population, neither of the family-based interventions improved BMI or health-related secondary outcomes. Future interventions should more fully address poverty and other social issues contributing to childhood obesity.
The recruitment of participants into community-based randomized controlled trials studying childhood obesity is often challenging, especially from low-income racial/ethnical minorities and when ...long-term participant commitments are required. This paper describes strategies used to recruit and enroll predominately low-income racial/ethnic minority parents and children into the Childhood Obesity Prevention and Treatment Research (COPTR) consortium.
The COPTR consortium has run four independent 3-year, multi-level (individual, family, school, clinic, and community) community-based randomized controlled trials. Two were prevention trials in preschool children and the other two were treatment trials in pre-adolescents and adolescent youth. All trials reported monthly participant recruitment numbers using a standardized method over the projected 18-24 months of recruitment. After randomization of participants was completed, recruitment staff and investigators from each trial retrospectively completed a survey of recruitment strategies and their perceived top three recruitment strategies and barriers.
Recruitment was completed in 15-21 months across trials, enrolling a total of 1745 parent-child dyads- out of 6314 screened. The number of children screened per randomized child was 4.6 and 3.5 in the two prevention trials, and 3.1 and 2.5 in the two treatment trials. Recruitment strategies reported included: (1) careful planning, (2) working with trusting community partners, (3) hiring recruitment staff who were culturally sensitive, personality appropriate, and willing to work flexible hours, (4) contacting potential participants actively and repeatedly, (5) recruiting at times and locations convenient for participants, (6) providing incentives to participants to complete baseline measures, (7) using a tracking database, (8) evaluating whether participants understand the activities and expectations of the study, and (9) assessing participants' motivation for participating. Working with community partners, hiring culturally sensitive staff, and contacting potential participants repeatedly were cited by two trials among their top three strategies. The requirement of a 3-year commitment to the trial was cited by two trials to be among the top three recruitment barriers.
Comprehensive strategies that include community partnership support, culturally sensitive recruitment staff, and repeated contacts with potential participants can result in successful recruitment of low-income racial/ethnic minority families into obesity prevention and treatment trials.
NET-Works trial: ClinicalTrials.gov, NCT01606891 . Registered on 28 May 2012. GROW trial: ClinicalTrials.gov, NCT01316653 . Registered on 16 March 2011. GOALS trial: ClinicalTrials.gov, NCT01642836 . Registered on 17 July 2012. IMPACT trial: ClinicalTrials.gov, NCT01514279 . Registered on 23 January 2012.
Background Non-adherence to diabetes medication leads to poor outcomes and increased healthcare costs. Multiple factors affecting adherence in adults with type 2 diabetes (T2D) have been identified, ...but pediatric data is sparse. We aimed to determine whether initiation of additional oral medications or insulin affects adherence to primary study medication (PSM) in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. Methods Six hundred and ninety-nine youth (aged 10-17 years) with recent-onset T2D were randomized in the TODAY study. Participants were categorized as adherent (≥80% taken by pill count) or non-adherent (<80%), and adherence was compared between those on additional medications or not. Subgroup analyses to assess influence of race/ethnicity, gender, medication type, or depression were performed. Results At 36 months, 46.3% of participants were taking additional oral medications and 31.9% were on insulin. There was no difference in study medication adherence with additional oral medications (55.1%, 67.1%, and 56.7% at month 36 in those prescribed 0, 1, or 2+ additional medications; p = 0.16). Girls on oral contraceptives (OC) had higher adherence (65.2% vs. 55.8% at month 36; p = 0.0054). Participants on insulin had lower adherence (39.7% vs. 59.3% at 36 months; p < 0.0001). There was decreased adherence in participants with baseline depression (p = 0.008). Conclusions Additional oral medications did not influence adherence to diabetes medications in TODAY. Addition of insulin led to reduced adherence. In subgroup analyses, OC use was associated with higher adherence in girls, while baseline depression was associated with lower adherence overall. Further studies examining potentially modifiable risk factors of adherence in pediatric T2D are needed.
The study objective was to examine the prevalence of depressive symptoms and relationships to quality of life and demographics in the Treatment Options for Type 2 Diabetes in Adolescents and Youth ...(TODAY) study's large, ethnically diverse youth with type 2 diabetes.
A total of 704 youth with type 2 diabetes <2 years' duration, aged 10-17 years, and BMI ≥85th percentile completed depressive symptoms and quality of life measures.
Some 14.8% reported clinically significant depressive symptoms, and older girls had significantly higher rates than older boys.
Rates of significant depressive symptoms were similar to those of healthy adolescents and lower than those of teens with type 1 diabetes. Elevated depressive symptoms, particularly in older girls, suggest clinicians assess vulnerability.
•Continuous glucose monitoring devices provide similar results on repeat testing in the home setting regarding time spent >140 mg/dL of 17.5% or more and time spent >180 mg/dL of 3.4% or ...more.•Continuous glucose monitoring devices provided discrepant results regarding time spent >140 mg/dL of ≥4.5% in 1/4 cases.•At-home mixed meal tolerance tests can safely be assessed on continuous glucose monitoring devices, but methods to ensure protocol adherence and thresholds to define abnormality are needed.
Cystic fibrosis related diabetes (CFRD) is associated with insulin-remediable pulmonary decline, so early detection is critical. Continuous glucose monitors (CGM) have shown promise in screening but are not recommended by clinical practice guidelines. Little is known about the reproducibility of CGM results for a given patient.
Twenty non-insulin treated adults and adolescents with CF placed an in-home CGM and wore it for two 14-day periods. Participants underwent a mixed meal tolerance test (MMTT) on day 5 of each 14-day period. Glycemic data from CGM 1 and CGM 2 were compared regarding published thresholds to define abnormality: percent time >140 mg/dL of ≥4.5%, percent time >140 mg/dL of >17.5%, and percent time >180 mg/dL of >3.4%. Results of the repeat MMTT were compared for peak glucose and 2-hour glucose thresholds: >140 mg/dL, >180 mg/dL, and >200 mg/dL.
For percent time >140 mg/dL of ≥ 4.5%, five of 20 subjects had conflicting results between CGM 1 and CGM 2. For percent time >140 mg/dL of >17.5% and >180 mg/dL of >3.4%, only one of 20 subjects had conflicting results between CGM 1 and CGM 2. On the MMTT, few participants had a 2-hour glucose >140 mg/dL. Peak glucose >140 mg/dL, 180 mg/dL, and 200 mg/dL were more common, with 10–37% of participants demonstrating disagreement between CGM 1 and CGM 2.
Repeated in-home CGM acquisitions show reasonable reproducibility regarding the more stringent thresholds for time >140 mg/dL and >180 mg/dL. More data is needed to determine thresholds for abnormal mixed meal tolerance tests in CFRD screening.
This study evaluated the effects of continuous glucose monitoring (CGM) combined with family behavioral intervention (CGM+FBI) and CGM alone (Standard-CGM) on glycemic outcomes and parental quality ...of life compared with blood glucose monitoring (BGM) in children ages 2 to <8 years with type 1 diabetes.
This was a multicenter (
= 14), 6-month, randomized controlled trial including 143 youth 2 to <8 years of age with type 1 diabetes. Primary analysis included treatment group comparisons of percent time in range (TIR) (70-180 mg/dL) across follow-up visits.
Approximately 90% of participants in the CGM groups used CGM ≥6 days/week at 6 months. Between-group TIR comparisons showed no significant changes: CGM+FBI vs. BGM 3.2% (95% CI -0.5, 7.0), Standard-CGM vs. BGM 0.5% (-2.6 to 3.6), CGM+FBI vs. Standard-CGM 2.7% (-0.6, 6.1). Mean time with glucose level <70 mg/dL was reduced from baseline to follow-up in the CGM+FBI (from 5.2% to 2.6%) and Standard-CGM (5.8% to 2.5%) groups, compared with 5.4% to 5.8% with BGM (CGM+FBI vs. BGM,
< 0.001, and Standard-CGM vs. BGM,
< 0.001). No severe hypoglycemic events occurred in the CGM+FBI group, one occurred in the Standard-CGM group, and five occurred in the BGM group. CGM+FBI parents reported greater reductions in diabetes burden and fear of hypoglycemia compared with Standard-CGM (
= 0.008 and 0.04) and BGM (
= 0.02 and 0.002).
CGM used consistently over a 6-month period in young children with type 1 diabetes did not improve TIR but did significantly reduce time in hypoglycemia. The FBI benefited parental well-being.
Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We ...conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.
A total of 80 children aged 2.0-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy.
There were no episodes of severe hypoglycemia or diabetic ketoacidosis. By study end, HbA1c decreased by 0.55% (6.0 mmol/mol) (P < 0.0001). Time with sensor glucose levels in target range 70-180 mg/dL increased by 10.9%, or 2.6 h/day (P < 0.0001), while time with levels <70 mg/dL declined by median 0.27% (P = 0.0204).
Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.
Aim
Managing type 1 diabetes in young children can cause significant stress for parents. Continuous glucose monitoring (CGM) may reduce parental burden. The Strategies to Enhance CGM Use in Early ...Childhood (SENCE) trial randomized parents of children (ages 2 to <8 years) with type 1 diabetes to CGM with family behavioural intervention (CGM + FBI), CGM alone (Standard‐CGM) or blood glucose monitoring for 26 weeks before receiving CGM + FBI (BGM‐Crossover). This report assesses changes in psychosocial outcomes for all groups over 52 weeks.
Methods
CGM + FBI (n = 45), Standard‐CGM (n = 42) and BGM‐Crossover (n = 44) participants completed psychosocial assessments at baseline, 26 weeks and 52 weeks. Repeated measures linear regression models evaluated change within and between treatment groups.
Results
The BGM‐Crossover group reported improved diabetes burden (Δ −6.9, 95% CI −11.3, −2.6, p = 0.003), fear of hypoglycaemia (Δ −6.4, CI −10.1, −2.6, p = 0.002) and technology satisfaction (Δ 7.3, CI 2.4, 12.2, p = 0.005) from 26 to 52 weeks, similar to published findings in the CGM + FBI group over the first 26 weeks. The Standard‐CGM group reported increased technology satisfaction (Δ 7.3, CI 0.6, 14.0, p = 0.027) from baseline to 52 weeks. The CGM + FBI group reported less diabetes burden and fear of hypoglycaemia from baseline to 52 weeks, but changes were not statistically significant. Scores from 26 to 52 weeks did not deteriorate.
Conclusions
Parents demonstrated psychosocial benefits following FBI that appeared to maintain without additional intervention. CGM‐focused education with behavioural support likely helps parents of young children with type 1 diabetes reduce burden and worry in the short‐ and long‐term.
OBJECTIVE
The study objective was to examine the prevalence of depressive symptoms and relationships to quality of life and demographics in the Treatment Options for Type 2 Diabetes in Adolescents ...and Youth (TODAY) study’s large, ethnically diverse youth with type 2 diabetes.
RESEARCH DESIGN AND METHODS
A total of 704 youth with type 2 diabetes <2 years’ duration, aged 10–17 years, and BMI ≥85th percentile completed depressive symptoms and quality of life measures.
RESULTS
Some 14.8% reported clinically significant depressive symptoms, and older girls had significantly higher rates than older boys.
CONCLUSIONS
Rates of significant depressive symptoms were similar to those of healthy adolescents and lower than those of teens with type 1 diabetes. Elevated depressive symptoms, particularly in older girls, suggest clinicians assess vulnerability.
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