Dysglycemia among youth with type 1 diabetes and suboptimal glycemic control in The Flexible Lifestyle Empowering Change (FLEX) trial

Abstract

Objective: To examine the prevalence and correlates of non-severe hypoglycemia among adolescents with type 1 diabetes and suboptimal glycemic control, an understudied topic in this group. Methods: Seven days of blinded continuous glucose monitor data were analyzed in 233 adolescents at baseline of the Flexible Lifestyle Empowering Change trial (13-16 years, type 1 diabetes duration >1 year, and hemoglobin A1c [HbA1c] 8-13% [64-119 mmol]). Incidence of clinical hypoglycemia (54-69 mg/dL) and clinically serious hypoglycemia (<54 mg/dL) was defined as number of episodes ≥15 minutes. Logistic regression modeling was used to determine the correlates of long duration of hypoglycemia, categorized by median split among those who experienced hypoglycemia. Results: The sample was 76.1% non-Hispanic white, 49.8% female, age = 14.9 AE 1.1 years, diabetes duration = 6.4 AE 3.7 years, and HbA1c = 9.6 AE 1.2% (81 AE 13 mmol/mol). Over 7 days, 79.4% of youth experienced ≥1 hypoglycemic episodes of <70 mg/dL, and 55.4% of youth experienced ≥1 hypoglycemic episodes of <54 mg/dL. Among all adolescents, the median duration of clinical hypoglycemia and clinically serious hypoglycemia was 21.9 (range 0-250.2) and 4.3 (range 0-209.7) minutes/day, respectively. Long duration of clinical hypoglycemia (range 1.8-17.4% time overall) and clinically serious hypoglycemia (range 1.2-14.6% time overall) was associated with older age and decreasing HbA1c. Long duration of clinically serious hypoglycemia also was associated with insulin pump use.Conclusions: Almost 80% of adolescents with elevated HbA1c had an episode of clinical hypoglycemia, and >50% had clinically serious hypoglycemia in a week. Increased education alongside access to emerging diabetes technologies may help to prevent hypoglycemia while improving glycemic control. K E Y W O R D Sblood glucose, diabetes mellitus, type 1, glycated hemoglobin A, hypoglycemia

Assessment of a Precision Medicine Analysis of a Behavioral Counseling Strategy to Improve Adherence to Diabetes Self-management Among Youth

“…For example, effect modification analyses of the FLEX trial showed that the intervention effect was stronger among participants with high vs low baseline HbA 1c percentages at 12 months (effect, 0.69%; 95% CI, 0.07%-1.31%; P for interaction = 0.03) and for female vs male participants at the 18 months (difference, 0.62; 95% CI, 0.03-1.21; P for interaction = 0.04). 6 In settings where more complex heterogeneity in participant profiles reliably predicts differential response to the efficacy of treatment, the precision medicine approach offers particular promise and addresses certain limitations of traditional effect modification. 7 The precision medicine approach seeks to develop an individualized treatment rule (ITR), a mathematical function that gives recommendations for whether a participant should receive intervention or not.…”

“…Analysis of differential response observed in a completed trial may take the form of an effect modification analysis, in which the observed effect of an intervention is examined across levels of a third, prespecified effect modifier variable. For example, effect modification analyses of the FLEX trial showed that the intervention effect was stronger among participants with high vs low baseline HbA 1c percentages at 12 months (effect, 0.69%; 95% CI, 0.07%-1.31%; P for interaction = 0.03) and for female vs male participants at the 18 months (difference, 0.62; 95% CI, 0.03-1.21; P for interaction = 0.04) …”

Pre‐exercise protein intake is associated with reduced time in hypoglycaemia among adolescents with type 1 diabetes

“…The FLEX study is registered on clinicaltrials.gov, NCT01286350, and a detailed description of the design, 17 main results 18,38 and secondary analyses [39][40][41][42] of the FLEX study have been previously published.…”

Mindfulness, disordered eating, and impulsivity in relation to glycemia among adolescents with type 1 diabetes and suboptimal glycemia from the Flexible Lifestyles Empowering Change ( FLEX ) intervention trial

“…Given that the Child and Adolescent Mindfulness Measure (CAMM) was only collected at the 12-and 18-month visits, the present analyses used only 18-month CGM data. Consistent with previous FLEX analyses, 39,40 participants were included in the present analysis if they had greater than 24 total hours of CGM data over the seven-day wear period. Of the 198 participants with CGM data at 18-months, 131 also had CAMM data at 18-months.…”