Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial.

BACKGROUND: Severe hypoglycemia is a common and feared complication of medications used to lower blood glucose levels in individuals with diabetes. Psychoeducational interventions can prevent severe hypoglycemia in individuals with type 1 diabetes (T1D). We aim to determine the effectiveness of this approach among adults with type 2 diabetes (T2D) at elevated risk for severe hypoglycemia. METHODS: Preventing Hypoglycemia in Type 2 diabetes (PHT2) is a two-arm, parallel, randomized controlled trial. Participants are eligible if they are adults with T2D receiving care at an integrated group practice in Washington state and have experienced one or more episodes of severe hypoglycemia in the prior 12 months or have impaired awareness of hypoglycemia (Gold score ≥ 4). Participants are randomized to proactive nurse care management with or without my hypo compass, an evidence-based, psychoeducational intervention combining group and individual self-management training. For this study, my hypo compass was adapted to be suitable for adults with T2D and from an in-person to a virtual intervention over videoconference and telephone. The primary outcome is any self-reported severe hypoglycemia in the 12 months following the start of the intervention. Secondary outcomes include biochemical measures of hypoglycemia, self-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. The study includes a process evaluation to assess implementation fidelity and clarify the causal pathway. CONCLUSION: The PHT2 trial will compare the effectiveness of two approaches for reducing severe hypoglycemia in adults with T2D. TRIAL REGISTRATION: clinicaltrials.gov, # NCT04863872.

Creating a clinical screening questionnaire for eating behaviors associated with overweight and obesity.

OBJECTIVE: The objective of this study was to associate questions about specific eating behaviors with weight. Our ultimate goal was to create a clinical screening questionnaire for eating behaviors associated with overweight and obesity. METHODS: We developed a questionnaire based on eating behaviors associated with overweight and obesity. After pilot testing and revision, we administered the questionnaire to patients in 2 primary care clinics from the Utah Health Research Network. We analyzed the relationship between measured body mass index, demographic factors, and responses to screening questions about eating behaviors and physical activity. RESULTS: We collected 261 completed questionnaires with weight and height measurements. With regression analysis, questions about consumption of beverages with sugar added, fruits and vegetables, and full portions served at restaurants as well as questions about physical activity were associated with body mass index and being overweight and/or obese. CONCLUSIONS: We suggest that future research about eating behaviors focus on the questions regarding typical consumption of beverages with sugar added, fruits and vegetables, and full portions served at restaurants to further develop a tool for clinical screening.