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

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 am...

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Bibliographic Details
Published in:	Contemporary clinical trials Vol. 139; p. 107456
Main Authors:	Ralston, James D., Anderson, Melissa, Ng, Janet, Bashir, Ayat, Ehrlich, Kelly, Burns-Hunt, Dena, Cotton, Meredith, Hansell, Laurel, Hsu, Clarissa, Hunt, Helen, Karter, Andrew J., Levy, Shaula M., Ludman, Evette, Madziwa, Lawrence, Omura, Emily M., Rogers, Kristine, Sevey, Brandie, Shaw, James A.M., Shortreed, Susan M., Singh, Umesh, Speight, Jane, Sweeny, Amber, Tschernisch, Katherine, Sergei Tschernisch, S., Yarborough, Laura
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-04-2024
Subjects:	Adult Blood Glucose - metabolism Blood Glucose Self-Monitoring Diabetes Mellitus, Type 1 - complications Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - drug therapy Humans Hypoglycemia Hypoglycemia - chemically induced Hypoglycemia - prevention & control Hypoglycemic Agents - adverse effects Impaired awareness of hypoglycemia Insulin - therapeutic use Type 2 diabetes Type 2 diabetes Hypoglycemia Impaired awareness of hypoglycemia
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Summary:	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. 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. The PHT2 trial will compare the effectiveness of two approaches for reducing severe hypoglycemia in adults with T2D. Trial registration: clinicaltrials.gov, # NCT04863872 •The Preventing Hypoglycemia in Type 2 Diabetes trial (PHT2) compares two approaches for reducing severe hypoglycemia in individuals with type 2 diabetes.•Participants are randomized to one of two intervention groups: a) proactive nurse care management; or b) proactive nurse care management plus my hypo compass, an evidence-based, psychoeducational intervention combining group and individual self-management training that reduces severe hypoglycemia frequency in individuals with type 1 diabetes.•The my hypo compass intervention protocol was adapted for virtual delivery to individuals with type 2 diabetes over videoconferencing and phone.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	1551-7144 1559-2030
DOI:	10.1016/j.cct.2024.107456