Program ACTIVE II: 6- and 12-month outcomes of a treatment approach for major depressive disorder in adults with type 2 diabetes.

AIMS: To evaluate the long-term effects of behavioral treatments on glycemic and psychological outcomes for patients with major depressive disorder (MDD) and type 2 diabetes (T2D). METHODS: Program ACTIVE II was a multicenter randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), exercise (EXER), combination treatment (CBT + EXER) and usual care (UC) for adults with MDD and T2D. RESULTS: Primary outcomes: change in A1c and depressive symptoms at 6- (N = 87) and 12-months (N = 75) from baseline. In those with a baseline A1c ≥7.0 %, CBT + EXER showed lasting A1c benefit at 6- (-1.2 %; SE: 0.6; p = 0.032) and 12-months (-1.4 %; SE: 0.6; p = 0.025) compared to UC. All groups had clinically significant improvements in depressive symptoms. At 6 months, CBT + EXER had significant improvements in diabetes-related distress regimen burden (p = 0.005); and social support (CIRS, p = 0.043) compared to UC. CONCLUSIONS: The Program ACTIVE II CBT + EXER intervention demonstrated a sustained improvement in A1c for a subgroup of study participants with a baseline A1c ≥7.0 %. However, this finding should be considered preliminary because of small sample size. All 3 behavioral intervention groups demonstrated improvements in psychosocial outcomes one-year post-intervention. These findings point to the enduring benefits of community-based interventions to extend the availability of depression treatment for T2D patients.

Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes.

BACKGROUND: Participant recruitment for clinical trials is a significant challenge for the scientific research community. Federal funding agencies have made continuation of funding of clinical trials contingent on meeting recruitment targets. It is incumbent on investigators to carefully set study recruitment timelines and resource needs to meet those goals as required under current funding mechanisms. This paper highlights the cost, labor, and barriers to recruitment for Program ACTVE II, a successful multisite randomized controlled trial of behavioral treatments for depression in adults with type 2 diabetes, conducted in rural and urban settings in three states. METHODS: Quantitative and qualitative data on recruitment were gathered from study staff throughout the study recruitment period and were used to calculate costs and effort. The study utilized two main approaches to recruitment: (1) relying on potential participants to see ads in the community and call a toll-free number; and (2) direct phone calls to potential participants by study staff. RESULTS: Contact was attempted with 18,925 people to obtain the enrolled sample of 140. The cost of recruitment activities during the 4.5-year recruitment period totaled $190,056, an average cost of $1358 per enrolled participant. Qualitative evaluations identified multiple barriers to recruitment. CONCLUSIONS: Recruitment for Program ACTIVE II exemplifies the magnitude of resources needed to reach recruitment targets in the current era. Continuous evaluation, flexibility, and adaptation are required on the part of investigators, community partners, and funding agencies to successfully reach high-risk populations in rural and urban areas. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03371940 . Registered on 13 December 2017.

National athletic trainers' association position statement: management of the athlete with type 1 diabetes mellitus.

OBJECTIVE: To present recommendations for the certified athletic trainer in the management of type 1 diabetes in the athlete. BACKGROUND: In managing diabetes, the most important goal is to keep blood glucose levels at or as close to normal levels as possible without causing hypoglycemia. This goal requires the maintenance of a delicate balance among hypoglycemia, euglycemia, and hyperglycemia, which is often more challenging in the athlete due to the demands of physical activity and competition. However, effectively managing blood glucose, lipid, and blood pressure levels is necessary to ensuring the long-term health and well-being of the athlete with diabetes. RECOMMENDATIONS: These recommendations are intended to provide the certified athletic trainer participating in the management of an athlete with type 1 diabetes mellitus with the specific knowledge and problem-solving skills needed. Athletic trainers have more contact with the athlete with diabetes than most members of the diabetes management team do and so must be prepared to assist the athlete as required.