Recruiting

Pharmacist Support

Sponsor:

Kaiser Permanente

Code:

NCT06746714

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Usual care, after system-side dissemination of HOAP

Study Details

Brief 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.

Conditions

Diabetes

Study ID

NCT06746714

Start date

Jul 20, 2023

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
9. 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).

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention group

Intervention group, receiving protocol-driven outreach by a clinical pharmacist (the "hypoglycemia champion", or HC) to hypoglycemia-prone patients with T2D

active comparator: Usual care group

Usual care, after system-wide dissemination of HOAP

Interventions

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.

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.

Primary outcome measure

  • Number of patients with sulfonylureas, mealtime, or mixed insulin discontinued [ Time Frame: 6 months ]
  • Proportion of patient with "excess hypoglycemia" [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Lisa K Gilliam, MD, PhD

650-676-7584lisa.k.gilliam@kp.org

Andrew J Karter, PhD

206-817-5391andy.j.karter@kp.org

Locations

Kaiser Permanente Department of Research

Recruiting

Pleasanton, California, United States, 94588

Contacts

Lisa K Gilliam, MD, PhD

650-676-7584lisa.k.gilliam@kp.org

Andrew J Karter, PhD

1-206-817-5391andy.j.karter@kp.org

Principal Investigator:

Lisa K Gilliam, MD, PhD

More Information

Sponsor

Kaiser Permanente

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • hypoglycemia
  • population management
  • clinical guideline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.