No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
250 (estimated)
Sponsor
Kaiser Permanente · Other
Who this trial is looking for
This trial is looking for people with type 2 diabetes who are at risk of severe low blood sugar. Participants will receive support from a clinical pharmacist using new guidelines to help manage their condition safely.
Are You a Good Fit for This Trial?
You may be able to join if
I am an active member of KPNC with a valid medical record number.
I am 18 years or older.
I am part of the KPNC diabetes registry.
I have likely type 2 diabetes.
I am at high risk for hypoglycemia.
You may not be able to join if
I have dementia or impaired cognition.
I have a diagnosis of psychosis or schizophrenia.
I have end-stage renal disease.
I have 'no contact' preferences on file.
I do not have a primary care physician.
I am receiving care at a skilled nursing facility.
I am deceased.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-ri…
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.
Trial Locations
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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 dev…
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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