Browse by author
Lookup NU author(s): Ayat Bashir, Professor James Shaw
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
© 2024 Elsevier Inc.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
Author(s): Ralston JD, Anderson M, Ng J, Bashir A, Ehrlich K, Burns-Hunt D, Cotton M, Hansell L, Hsu C, Hunt H, Karter AJ, Levy SM, Ludman E, Madziwa L, Omura EM, Rogers K, Sevey B, Shaw JAM, Shortreed SM, Singh U, Speight J, Sweeny A, Tschernisch K, Sergei Tschernisch S, Yarborough L
Publication type: Article
Publication status: Published
Journal: Contemporary Clinical Trials
Year: 2024
Volume: 139
Print publication date: 01/04/2024
Online publication date: 20/01/2024
Acceptance date: 19/01/2024
ISSN (print): 1551-7144
ISSN (electronic): 1559-2030
Publisher: Elsevier Inc.
URL: https://doi.org/10.1016/j.cct.2024.107456
DOI: 10.1016/j.cct.2024.107456
PubMed id: 38253252
Altmetrics provided by Altmetric
