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Abstract
<jats:p><p dir="ltr"><b>Objective:</b> Hypoglycemia, a major cause of morbidity for people with diabetes, is underrecognized in primary care, leading to underutilization of risk mitigation strategies. This study reports the development and acceptability/feasibility testing of the Hypoglycemia Prevention Program (HPP), an electronic health record integrated toolkit for primary care.</p><p dir="ltr"><b>Research Design and Methods:</b> The HPP was developed through stakeholder engagement, and included a pre-visit hypoglycemia history survey, primary care provider (PCP) hypoglycemia toolkit, and patient self-management handout. The HPP pilot study was a pre-post clinical trial at one primary care practice. Participants were adults with diabetes treated with insulin or sulfonylureas, their PCPs and clinic staff. The primary outcome was acceptability; exploratory outcomes included pre- to post-intervention change in PCP hypoglycemia prevention actions, self-reported hypoglycemia and optional blinded 10-day continuous glucose monitoring (CGM).</p><p dir="ltr"><b>Results:</b> The intervention was completed by 31 of 35 enrolled people with diabetes (89%) for whom it triggered frequent hypoglycemia alerts. The intervention was rated acceptable or completely acceptable by 87% of people with diabetes and 100% of participating PCPs (N=12) and clinic staff (N=5). PCPs increased indicated glucagon prescribing from pre- to post-intervention (0% to 32%, p=0.003); there were small increases in CGM initiation and deintensification of hypoglycemia-causing medications. Self-reported and CGM-detected hypoglycemia decreased from pre- to post-intervention, although with incomplete ascertainment and low CGM participation (N=11).</p><p dir="ltr"><b>Conclusions:</b> A hypoglycemia prevention program designed for primary care is feasible to implement and acceptable to clinical and patient stakeholders, with evidence of improved hypoglycemia prevention efforts. Further efficacy evaluation is needed.</p><p><br></p><p dir="ltr"><b>Clinical Trials Registration:</b></p><p dir="ltr">ClinicalTrials.gov number NCT06353217</p><p dir="ltr">https://clinicaltrials.gov/study/NCT06353217</p><p><br></p><p><br></p><p dir="ltr"><b>Article Highlights</b></p><p dir="ltr">· <b>Why did we undertake this study?</b> We developed the Hypoglycemia Prevention Program (HPP), an electronic health record integrated toolkit, to address current gaps in hypoglycemia prevention in primary care.</p><p dir="ltr">· <b>What is the specific question we wanted to answer?</b> We evaluated the acceptability and feasibility of the HPP among people with diabetes at risk for hypoglycemia, their primary care providers, and clinic staff.</p><p dir="ltr">· <b>What did we find? </b>Stakeholders developed the HPP tools, which included a hypoglycemia assessment survey, clinical alerts and orders, and patient education. The HPP was feasible to implement and highly acceptable to patient and clinical stakeholders.</p><p dir="ltr">· <b>What are the implications of our findings? </b>The HPP is a promising intervention to promote hypoglycemia risk reduction in primary care practice and should be evaluated for clinical efficacy.</p></jats:p>