Efficacy of the Flexible Lifestyles Empowering Change intervention on metabolic and psychosocial outcomes in adolescents with type 1 diabetes (FLEX): a randomised controlled trial

Abstract

National Institutes of Health and National Institute of Diabetes Digestive Diseases and Kidney and the Helmsley Charitable Trust.

Identification of clinically relevant dysglycemia phenotypes based on continuous glucose monitoring data from youth with type 1 diabetes and elevated hemoglobin A1c

“…Outside of the clinic, the results may be used toward the development of effective interventions for this at‐risk and challenging adolescent population . Although main analysis of the FLEX intervention did not show improvements in HbA1c at 18 months, a three‐way interaction term between cluster, FLEX intervention randomization assignment, and timepoint was tested in exploratory longitudinal analyses; it was not statistically significant. It is possible that approaches to diabetes management in the heterogenous adolescent population are maximally effective as a set of interventions tailored to specific issues of dysglycemia, which can then be targeted toward phenotypes that are expected to maximally benefit.…”

“…Data were analyzed from the baseline visit of the Flexible Lifestyles Empowering Change randomized trial (FLEX) (http://clinicaltrials.gov identifier: NCT01286350). FLEX was a randomized clinical trial testing an adaptive, 18‐month intervention including behavioral skills and problem solving for youth with T1D, with respect to HbA1c (primary outcome), glycemic variability, CVD risk factors, health‐related quality of life, and cost effectiveness . The study was conducted at two pediatric endocrinology diabetes clinics in Colorado and Ohio, USA, with institutional review board approval for ethical conduct of human subjects research at each institution and at the coordinating center located in North Carolina.…”

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

“…This randomized clinical trial tested an adaptive, 18-month intervention that included interventions to improve behavioral skills and problem solving for adolescents with type 1 diabetes, with respect to HbA 1c percentage of total hemoglobin (primary outcome), glycemic variability, cardiovascular disease risk factors, health-related QOL, and cost-effectiveness. 1 , 9 Eligible participants were adolescents aged 13 to 16 years with type 1 diabetes for 1 or more years with literacy in English, HbA 1c percentage of total hemoglobin of 8.0% to 13.0% (to convert to proportion of total hemoglobin, multiply by 0.01), at least 1 primary caregiver available to participate, and no other serious medical conditions or pregnancy. 9 Those randomized to the control arm received usual diabetes care.…”

“… 1 Despite high retention and fidelity, the FLEX study did not show efficacy with respect to the primary outcome of hemoglobin A 1c (HbA 1c ) percentage 18 months after randomization. 1 However, the intervention was associated with improvements in several secondary psychosocial outcomes, including motivation, problem-solving skills, diabetes self-management, and health-related and general quality of life (QoL). 1 …”

“… 1 However, the intervention was associated with improvements in several secondary psychosocial outcomes, including motivation, problem-solving skills, diabetes self-management, and health-related and general quality of life (QoL). 1 …”