CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06746714
NCT06746714N/ACompleted

Testing a New Population Management Model for Hypoglycemia Prevention in High-Risk KPNC Members

Kaiser Permanente·interventional·Posted Dec 24, 2024·Updated Dec 24, 2024

In Brief

A clinical study evaluating Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia) and Usual care, after system-side dissemination of HOAP for Diabetes. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Severe low blood sugar (hypoglycemia) is a serious problem for people with diabetes. It can lead to dangerous falls, heart problems, memory issues, and even death. However, many healthcare providers don't recognize or manage this problem well. The investigators believe that creating a clear set of guidelines for preventing hypoglycemia, along with having a clinical pharmacist actively help high-risk patients, can make diabetes treatment safer. In this study, the investigators developed a simple, evidence-based guide called "Hypoglycemia on a Page" (HOAP) to prevent low blood sugars. The investigators then tested it by comparing two groups of patients with type 2 diabetes who are at high risk for hypoglycemia. One group received active support from a clinical pharmacist using the HOAP guidelines, while the other group received standard care. The main goal of this study is to see if the pharmacist's support leads to safer diabetes treatment. The investigators will also look at other factors, such as whether patients are prescribed glucagon (a medicine for severe low blood sugar), if they use continuous glucose monitoring, and whether they have worse blood sugar control or end up in the hospital for hypoglycemia. This trial aims to improve patient safety, health outcomes, and possibly lower healthcare costs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedDec 24, 2024
Enrollment StartJul 20, 2023
Primary CompletionJul 22, 2024
Study CompletionDec 20, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 1.5 years ago

Interventions

Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia)behavioral

The Hypoglycemia Champion (HC) pharmacist reviewed patient charts before conducting proactive outreach. They did not contact subjects with active psychiatric issues or those admitted to a skilled nursing facility. The patient's care team (PCP and APM) were also contacted for peer consent. The outreach process involved an initial phone call with a secure electronic message or mailed letter (for those without secure KPNC patient portal access) if the initial call was unsuccessful. A second and third phone call attempt was made for non-responders.

Usual care, after system-side dissemination of HOAPbehavioral

Patients had their diabetes treated as usual by their diabetes care provider or primary care physician, after system-wide dissemination of HOAP.