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Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

RecruitingNAAges 18 Years - anyAllKaiser Permanente
NCT06746714 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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).
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What it tests

  • Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia)
  • Usual care, after system-side dissemination of HOAP
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Where

1 site
Kaiser Permanente Department of Research
Pleasanton, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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