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Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

Sponsor: Kaiser Permanente • ClinicalTrials.gov ID: NCT06746714

Registry updated: 2026-10-14

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Description

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.

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

Eligibility criteria

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).

Conditions

Diabetes

Locations

Kaiser Permanente Department of Research — Pleasanton, California, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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