250 Participants NeededMy employer runs this trial

Hypoglycemia Prevention for Type 2 Diabetes

LK
AJ
Overseen ByAndrew J Karter, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kaiser Permanente
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

LK

Lisa K Gilliam, MD, PhD

Principal Investigator

The Permanente Medical Group

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are members of Kaiser Permanente Northern California, have a valid medical record number, and are considered at high risk for severe low blood sugar based on a special screening tool.

Inclusion Criteria

I am an active member of KPNC with a valid medical record number as of June 1, 2023.
I am at high risk for low blood sugar as per a specific test.
I am registered in the KPNC diabetes registry.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive proactive intervention by a clinical pharmacist using the HOAP guidelines to manage hypoglycemia risk

6 months
Regular visits as per protocol-driven outreach

Usual Care

Participants receive standard care with system-wide dissemination of HOAP

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Hypoglycemia on a Page (HOAP) Guidelines
  • Proactive population care with clinical pharmacist support

Trial Overview

The study compares usual diabetes care to proactive care using the 'Hypoglycemia on a Page' (HOAP) guide. In the proactive group, clinical pharmacists actively help high-risk patients follow HOAP guidelines to prevent dangerous drops in blood sugar.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention
Group II: Usual care groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+