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NCT06746714Recruiting

Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
250 (estimated)
First submitted
13 Dec 2024
Start date
20 Jul 2023
Primary completion date
31 Mar 2027
Lead sponsor
Kaiser Permanente
NCT number
NCT06746714

What you commit to

  • Study type: Interventional
  • Planned participants: 250
  • From 20 Jul 2023 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • receiving care at skill nursing facilities,
  • enrolled in concurrent pharmacy deprescribing pilots

Other illness

  • Dementia or impaired cognition,
  • end-stage renal disease,

Lab values

  • Pregnant patients
    • Aim 4: In addition to criteria above, participants will only include patients with type 2 diabetes (T2D) who use a CGM device, have authorized sharing of their CGM data with their healthcare provider and have evidence of "excess hypoglycemia" (\>=4% TBR on continuous glucose monitor readouts).

Other

  • psychosis or schizophrenia diagnosis,
  • "no contact" preferences on file,
  • no primary care physician or home facility,
  • deceased,

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kaiser Permanente Department of Research
Coordinator of this site? Confirm its status
PleasantonUnited StatesRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.