Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)

This study is a two-arm, individually-randomized, comparative effectiveness study of two evidence-based approaches to preventing severe hypoglycemia. We will identify participants using Electronic Health Record (EHR) data. They will be identified for potential recruitment if they are age 18 and older, diagnosed with type 2 diabetes, receiving primary care at Kaiser Permanente Washington and have a current prescription for insulin or identified using an EHR-based risk stratification tool as being at intermediate to high risk for a severe hypoglycemia event. Within this population, we will recruit participants who either have impaired awareness of hypoglycemia or self-report a severe hypoglycemia event in the prior 12 months. Participants must be members of Kaiser Permanente Washington and identified by the study.

Following randomization, we will compare patients who receive proactive care management from nurses to patients receiving proactive care management plus MyHC-T2D, a structured educational intervention that reduces the frequency of severe hypoglycemia in individuals with type 1 diabetes. In both groups, we will use proactive care management to assess and provide evidence-based care for impaired awareness of hypoglycemia and other potential contributors to severe hypoglycemia risk.

Our primary outcome is participant-reported severe hypoglycemia, to capture all events, including those not involving clinical care. We will also examine biochemical measures of hypoglycemia measured using continuous glucose monitoring (CGM), participant-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. We will conduct a process evaluation to assess the fidelity of implementation and clarify the causal pathway.

Inclusion criteria

• Age 18 years or older
• Diagnosed with type 2 diabetes
• Receiving primary care at Kaiser Permanente Washington (KPWA)
• Enrollment in KPWA at baseline and planning to stay with a KPWA health plan for the next 6 months
• Current prescription for insulin or at intermediate to high risk for severe hypoglycemia episode using the hypoglycemia risk stratification tool developed by Karter et. al.
• History of severe hypoglycemia in the prior 12 months or impaired awareness of hypoglycemia

Exclusion criteria

• Inability to give informed consent
• Unable to speak or read English
• Inability or unwillingness to attend online or telephone educational sessions, follow up calls, or to complete outcome assessments
• Prior diagnosis of dementia, severe psychiatric conditions with psychosis, severe cognitive impairment
• Currently living in a nursing home or under hospice care
• Current use at baseline of Continuous Glucose Monitor
• Pregnant or planning to become pregnant