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Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a pharmacist using a low blood sugar prevention guide can make diabetes care safer than usual care. It is for adults with likely type 2 diabetes who have a high risk of low blood sugar.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • An active KPNC member with a valid medical record number on June 1, 2023.
  • Age 18 or older.
  • Listed in the KPNC diabetes registry.
  • Likely to have type 2 diabetes, based on a tested screening method.
  • At high risk for low blood sugar, based on the study team's risk tool.
  • For Aim 4 only: Have type 2 diabetes and use a continuous glucose monitor (CGM), a device that tracks blood sugar.
  • For Aim 4 only: Have agreed to share CGM data with your healthcare provider.
  • For Aim 4 only: CGM readings show blood sugar below the target range at least 4% of the time.

Who can't join

  • Dementia or problems with memory or thinking.
  • A diagnosis of psychosis or schizophrenia, conditions that can affect your sense of reality.
  • End-stage kidney disease, when the kidneys no longer work well enough.
  • A request on file not to be contacted.
  • No primary care doctor or assigned care facility.
  • Receiving care in a skilled nursing facility.
  • Deceased or pregnant.
  • Taking part in another pharmacy pilot program to reduce or stop medicines.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

CA