Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

December 20, 2024 updated by: Lisa K Gilliam, Kaiser Permanente

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary research question is whether using a "Hypoglycemia Champion" (HC) to target high risk patients with type 2 diabetes (T2D) is a feasible and effective model of care to reduce hypoglycemia risk in this population.

The goals of this study are to:

  1. Develop an evidence-based, expert consensus clinical guideline, "Hypoglycemia on a Page" (HOAP), for hypoglycemia prevention in patients with T2D at high risk of hypoglycemia. Guideline development will include stakeholders across multiple Kaiser Permanente regions.
  2. Develop a workflow for use by a "Hypoglycemia Champion" (HC), a clinical pharmacist who will apply the HOAP guideline in the proactive, protocol-driven management of Kaiser Permanente Northern California (KPNC) members identified as having high hypoglycemic risk;
  3. Conduct a pragmatic, randomized trial of the proactive HC intervention vs. usual care on diabetes regimen safety among KPNC members at high risk of hypoglycemia. The investigators hypothesize that at 6 months, high-risk members assigned to the HC intervention will be prescribed safer diabetes regimens (defined as discontinuation of sulfonylureas and/or rapid-/short-acting or mixed insulins) compared to usual care.

The study design will include: 1) Engaging expert clinical stakeholders and experienced KP guideline developers to create an evidence-based hypoglycemia prevention algorithm (HOAP) analogous to KPNC's successful "PHASE on a Page" guideline for cardiovascular risk management; 2) Crafting a population-based workflow protocol for proactive outreach by the HC (specifically trained clinical pharmacist) to apply this new guideline to high-risk members; and 3) Performing a pragmatic randomized trial comparing proximal clinical outcomes (diabetes medication changes) available directly from the EHR between the intervention arm (pro-active outreach by the HC) vs. controls (usual care, including availability of the HOAP). The primary analysis will be intent-to-treat and will assess differences in the proportion of patients using safer diabetes regimens (relative to their baseline regimen) between study arms. The investigators will also examine heterogeneity of treatment effects by age, race/ethnicity, and prior severe hypoglycemia events. Deliverables include: 1) Inter-regional dissemination of the HOAP algorithm and the HC workflow protocol, 2) High quality, pragmatic RCT results to inform operational decision-making, and 3) Presentations and manuscripts to further disseminate findings. This study is highly relevant to TPMG and KP because: 1) Hypoglycemia is common, morbid, and costly, 2) Providers are challenged to address the competing demands of prescribing diabetes medications to meet glycemic targets while avoiding iatrogenic hypoglycemia, 3) No regional strategies currently exist to reduce hypoglycemia risk. This work has strategic implications for our organization because a new HEDIS measure proposed for measurement year 2023 will assess emergency department admissions for hypoglycemia in older adults with diabetes. Our proposal will address this gap in organizational clinical care by developing and evaluating a practical, proactive, population management approach to hypoglycemia prevention for members with T2D at high risk of hypoglycemia.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pleasanton, California, United States, 94588
        • Kaiser Permanente Department of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Active KPNC members with valid MRNs at baseline (06/01/2023),
  2. age >=18 years,
  3. in the KPNC diabetes registry,
  4. likely type 2 diabetes (determined using a validated algorithm
  5. high risk for hypoglycemia, determined using the hypoglycemia risk stratification tool developed by the investigator team

Exclusion Criteria:

  1. Dementia or impaired cognition,
  2. psychosis or schizophrenia diagnosis,
  3. end-stage renal disease,
  4. "no contact" preferences on file,
  5. no primary care physician or home facility,
  6. receiving care at skill nursing facilities,
  7. deceased,
  8. enrolled in concurrent pharmacy deprescribing pilots

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Intervention group, receiving protocol-driven outreach by a clinical pharmacist (the "hypoglycemia champion", or HC) to hypoglycemia-prone patients with T2D
Behavioral: Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia)
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.
Active Comparator: Usual care group
Usual care, after system-wide dissemination of HOAP
Behavioral: Usual care, after system-side dissemination of HOAP
Patients had their diabetes treated as usual by their diabetes care provider or primary care physician, after system-wide dissemination of HOAP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with sulfonylureas, mealtime, or mixed insulin discontinued
Time Frame: 6 months
We will test for differences in the proportion of patients prescribed safer diabetes regimens (i.e., discontinuation of sulfonylureas, mealtime or mixed insulin)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants prescribed CGM
Time Frame: 6 months
We will test for differences in the proportion of patients prescribed CGM
6 months
Number of participants prescribed glucagon
Time Frame: 6 months
We will test for differences in the proportion of patients prescribed glucagon
6 months
Number of participants with A1c <8%
Time Frame: 6 months
We will test for differences in the proportion of patients with good glycemic control (A1c <8%)
6 months
Number of participants with ED visit or hospitalization for hypoglycemia
Time Frame: 6 months
We will test for differences in the proportion of patients who had an ED visit or hospitalization for hypoglycemia
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Lisa K Gilliam, MD, PhD, The Permanente Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Actual)

July 22, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBNetID: 1980653

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data generated and/or analyzed by the described study are not publicly available due to institutional policies but are available from the corresponding author on reasonable request and with the appropriate IRB approvals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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