Hypoglycemia Prevention for High-Risk Type 2 Diabetes Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, randomized trial develops and applies the Hypoglycemia on a Page (HOAP) guideline to high-risk type 2 diabetes patients. A clinical pharmacist, acting as a Hypoglycemia Champion, uses HOAP to proactively manage patients identified as high risk within Kaiser Permanente Northern California. The study compares proactive HOAP-guided care to usual care, focusing on safety of diabetes regimens and reductions in hypoglycemia risk over six months. The HOAP guideline was created with stakeholder input and mirrors successful population-health guidelines used in cardiovascular risk management. Eligibility includes adult KPNC members with type 2 diabetes, high hypoglycemia risk, CGM-documented excess hypoglycemia, and consent for CGM data sharing.

Why it matters

Who can join: the full rules

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).

Where it's running

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

Study contacts

• Principal investigator: Lisa K Gilliam, MD, PhD — The Permanente Medical Group
• Study coordinator: Lisa K Gilliam, MD, PhD
• Email: lisa.k.gilliam@kp.org
• Phone: 650-676-7584

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.