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DiabetesNCT06746714

Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

A study testing Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia) in people with Diabetes, run by Kaiser Permanente at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes
What is being tested?
Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
20 Jul 2023to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Active KPNC members with valid MRNs at baseline (06/01/2023),
  • age >=18 years,
  • in the KPNC diabetes registry,
  • likely type 2 diabetes (determined using a validated algorithm)
  • high risk for hypoglycemia, determined using the hypoglycemia risk stratification tool developed by the investigator team

Who cannot join

  • Dementia or impaired cognition,
  • psychosis or schizophrenia diagnosis,
  • end-stage renal disease,
  • "no contact" preferences on file,
  • no primary care physician or home facility,
  • receiving care at skill nursing facilities,
Show all 10Show fewer
  • deceased,
  • enrolled in concurrent pharmacy deprescribing pilots
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa K Gilliam, MD, PhD contact

650-676-7584

lisa.k.gilliam@kp.org

Andrew J Karter, PhD contact

206-817-5391

andy.j.karter@kp.org

United States1 site, 1 recruiting

  • Kaiser Permanente Department of Research

    Pleasanton, California, 94588

    Lisa K Gilliam, MD, PhD, 650-676-7584, lisa.k.gilliam@kp.org

    Andrew J Karter, PhD, 1-206-817-5391, andy.j.karter@kp.org

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

The primary research question is whether using a "Hypoglycemia Champion" (HC) to target high risk patients with type 2 diabetes (T2D) is a feasible and effective model of care to reduce hypoglycemia risk in this population.

The goals of this study are to:

  1. Develop an evidence-based, expert consensus clinical guideline, "Hypoglycemia on a Page" (HOAP), for hypoglycemia prevention in patients with T2D at high risk of hypoglycemia. Guideline development will include stakeholders across multiple Kaiser Permanente regions.
  2. Develop a workflow for use by a "Hypoglycemia Champion" (HC), a clinical pharmacist who will apply the HOAP guideline in the proactive, protocol-driven management of Kaiser Permanente Northern California (KPNC) members identified as having high hypoglycemic risk;
  3. Conduct a pragmatic, randomized trial of the proactive HC intervention vs. usual care on diabetes regimen safety among KPNC members at high risk of hypoglycemia. The investigators hypothesize that at 6 months, high-risk members assigned to the HC intervention will be prescribed safer diabetes regimens (defined as discontinuation of sulfonylureas and/or rapid-/short-acting or mixed insulins) compared to usual care. The study design will include: 1) Engaging expert clinical stakeholders and experienced KP guideline developers to create an evidence-based hypoglycemia prevention algorithm (HOAP) analogous to KPNC's successful "PHASE on a Page" guideline for cardiovascular risk management; 2) Crafting a population-based workflow protocol for proactive outreach by the HC (specifically trained clinical pharmacist) to apply this new guideline to high-risk members; and 3) Performing a pragmatic randomized trial comparing proximal clinical outcomes (diabetes medication changes) available directly from the EHR between the intervention arm (pro-active outreach by the HC) vs. controls (usual care, including availability of the HOAP). The primary analysis will be intent-to-treat and will assess differences in the proportion of patients using safer diabetes regimens (relative to their baseline regimen) between study arms. The investigators will also examine heterogeneity of treatment effects by age, race/ethnicity, and prior severe hypoglycemia events. Deliverables include: 1) Inter-regional dissemination of the HOAP algorithm and the HC workflow protocol, 2) High quality, pragmatic RCT results to inform operational decision-making, and 3) Presentations and manuscripts to further disseminate findings. This study is highly relevant to TPMG and KP because: 1) Hypoglycemia is common, morbid, and costly, 2) Providers are challenged to address the competing demands of prescribing diabetes medications to meet glycemic targets while avoiding iatrogenic hypoglycemia, 3) No regional strategies currently exist to reduce hypoglycemia risk. This work has strategic implications for our organization because a new HEDIS measure proposed for measurement year 2023 will assess emergency department admissions for hypoglycemia in older adults with diabetes. The proposal will address this gap in organizational clinical care by developing and evaluating a practical, proactive, population management approach to hypoglycemia prevention for members with T2D at high risk of hypoglycemia.
  4. Conduct a prospective evaluation of whether proactive intervention by the Hypoglycemia Champion APM (i.e., assignment to augmented usual care group) is associated with reduced hypoglycemia among KPNC members with biochemical evidence of excess hypoglycemia, compared to usual care (control). The study will randomly assign eligible patients (patients who meet eligibility criteria and have "excess hypoglycemia" (>=4% time below range (TBR) on continuous glucose monitor (CGM) readouts)) to receive proactive intervention by the HC APM (augmented usual care group) for comparison to data-only patients receiving usual care. All eligible patients will be managed according to the regionally disseminated HOAP as the standard of care. All medical decisions for all patients (augmented usual care and usual care) are made by each member's medical care team responsible for his or her care (not by study personnel).
Conditions
Diabetes
Being tested
Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia), Usual care, after system-side dissemination of HOAP
Keywords
hypoglycemia, population management, clinical guideline
Medical subject headings
Diabetes Mellitus, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia)Behavioural

    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 HOAPBehavioural

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

Study groups in NCT06746714
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention group, receiving protocol-driven outreach by a clinical pharmacist (the "hypoglycemia champion", or HC) to hypoglycemia-prone patients with T2D
Receives: Behavioral: Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia)
Usual care groupActive comparatorUsual care, after system-wide dissemination of HOAP
Receives: Behavioral: Usual care, after system-side dissemination of HOAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with sulfonylureas, mealtime, or mixed insulin discontinued

    We will test for differences in the proportion of patients prescribed safer diabetes regimens (i.e., discontinuation of sulfonylureas, mealtime or mixed insulin)

    Measured: 6 months

  2. Proportion of patient with "excess hypoglycemia"

    Proportion of patients with "excess hypoglycemia" (>=4% TBR on continuous glucose monitor readouts) who achieve "acceptable levels of hypoglycemia" (<4% TBR on continuous glucose monitor readouts), comparing study participants (augmented usual care) to data-only patients (usual care controls).

    Measured: 6 months

Secondary outcomes (10)

  1. Number of participants prescribed CGM

    The study will test for differences in the proportion of patients prescribed CGM

    Measured: 6 months

  2. Number of participants prescribed glucagon

    The study will test for differences in the proportion of patients prescribed glucagon

    Measured: 3, 6, 12 months

  3. Number of participants with A1c <8%

    The study will test for differences in the proportion of patients with good glycemic control (A1c <8%)

    Measured: 3, 6, 12 months

  4. Number of participants with ED visit or hospitalization for hypoglycemia

    The study will test for differences in the proportion of patients who had an ED visit or hospitalization for hypoglycemia

    Measured: 6 months

  5. Percentage of patients who achieve "acceptable levels of hypoglycemia"

    Examine differences between study participants and data-only patients in the percentage of patients who achieve "acceptable levels of hypoglycemia"

    Measured: 6 and 12 months

  6. Number of study PharmD visits

    The study will examine the differences between participant arms for the number of PharmD visits.

    Measured: 3, 6, 12 months

  7. Diabetes Focused visits

    The study will examine the differences between participant arms for the number of diabetes focused visits.

    Measured: 3, 6, 12 months

  8. Changes in insulin regimens

    The study will examine the differences between participant arms for the changes in insulin regimens.

    Measured: 3, 6, 12 months

  9. Hypoglycemia on the problem list

    The study will examine the differences between participant arms for the presence of 'hypoglycemia' on the problem list.

    Measured: 3, 6, 12 months

  10. ED visits/ hospitalizations (any cause)

    The study will examine the differences between participant arms for number of ED visits or hospitalizations, for any cause.

    Measured: 3, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2024
  2. Study start20 Jul 2023
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06746714
Sponsor's protocol ID
IRBNetID: 1980653
Status last verified
Oct 2026
First submitted
13 Dec 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data generated and/or analyzed by the described study are not publicly available due to institutional policies but are available from the corresponding author on reasonable request and with the appropriate IRB approvals.

Publications

  • Karter AJ, Warton EM, Lipska KJ, Ralston JD, Moffet HH, Jackson GG, Huang ES, Miller DR. Development and Validation of a Tool to Identify Patients With Type 2 Diabetes at High Risk of Hypoglycemia-Related Emergency Department or Hospital Use. JAMA Intern Med. 2017 Oct 1;177(10):1461-1470. doi: 10.1001/jamainternmed.2017.3844.

    PubMed 28828479

  • Schroeder EB, Donahoo WT, Goodrich GK, Raebel MA. Validation of an algorithm for identifying type 1 diabetes in adults based on electronic health record data. Pharmacoepidemiol Drug Saf. 2018 Oct;27(10):1053-1059. doi: 10.1002/pds.4377. Epub 2018 Jan 2.

    PubMed 29292555

  • Klompas M, Eggleston E, McVetta J, Lazarus R, Li L, Platt R. Automated detection and classification of type 1 versus type 2 diabetes using electronic health record data. Diabetes Care. 2013 Apr;36(4):914-21. doi: 10.2337/dc12-0964. Epub 2012 Nov 27.

    PubMed 23193215

  • Parker MM, Moffet HH, Adams A, Karter AJ. An algorithm to identify medication nonpersistence using electronic pharmacy databases. J Am Med Inform Assoc. 2015 Sep;22(5):957-61. doi: 10.1093/jamia/ocv054. Epub 2015 Jun 15.

    PubMed 26078413

  • Karter AJ, Parker MM, Moffet HH, Ahmed AT, Schmittdiel JA, Selby JV. New prescription medication gaps: a comprehensive measure of adherence to new prescriptions. Health Serv Res. 2009 Oct;44(5 Pt 1):1640-61. doi: 10.1111/j.1475-6773.2009.00989.x. Epub 2009 Jun 3.

    PubMed 19500161

  • Moffet HH, Adler N, Schillinger D, Ahmed AT, Laraia B, Selby JV, Neugebauer R, Liu JY, Parker MM, Warton M, Karter AJ. Cohort Profile: The Diabetes Study of Northern California (DISTANCE)--objectives and design of a survey follow-up study of social health disparities in a managed care population. Int J Epidemiol. 2009 Feb;38(1):38-47. doi: 10.1093/ije/dyn040. Epub 2008 Mar 7. No abstract available.

    PubMed 18326513

  • Hui RL, Chang CC, Niu F, Tang YK, Harano D, Deguzman L, Kao DJ, Awsare S, Draves M. Evaluation of a Pharmacist-Managed Antidiabetic Deprescribing Program in an Integrated Health Care System. J Manag Care Spec Pharm. 2019 Aug;25(8):927-934. doi: 10.18553/jmcp.2019.25.8.927.

    PubMed 31347983

  • Kaur U, Machado M, Mistry A. Hypoglycemia: A closer look at a community pharmacist's impact in optimizing diabetes care. J Am Pharm Assoc (2003). 2022 Sep-Oct;62(5):1686-1693.e6. doi: 10.1016/j.japh.2022.04.002. Epub 2022 Apr 12.

    PubMed 35550730

  • Whitfield N, Gregory P, Liu B, Spratt S, Smith BH. Impact of pharmacist outreach on glucagon prescribing. J Am Pharm Assoc (2003). 2022 Jul-Aug;62(4):1384-1388.e1. doi: 10.1016/j.japh.2022.01.017. Epub 2022 Jan 31.

    PubMed 35151583

  • Choe HM, Mitrovich S, Dubay D, Hayward RA, Krein SL, Vijan S. Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial. Am J Manag Care. 2005 Apr;11(4):253-60.

    PubMed 15839185

  • Lipska KJ, Warton EM, Huang ES, Moffet HH, Inzucchi SE, Krumholz HM, Karter AJ. HbA1c and risk of severe hypoglycemia in type 2 diabetes: the Diabetes and Aging Study. Diabetes Care. 2013 Nov;36(11):3535-42. doi: 10.2337/dc13-0610. Epub 2013 Jul 30.

    PubMed 23900589

  • Kunutsor SK, Balasubramanian VG, Zaccardi F, Gillies CL, Aroda VR, Seidu S, Khunti K. Glycaemic control and macrovascular and microvascular outcomes: A systematic review and meta-analysis of trials investigating intensive glucose-lowering strategies in people with type 2 diabetes. Diabetes Obes Metab. 2024 Jun;26(6):2069-2081. doi: 10.1111/dom.15511. Epub 2024 Feb 26.

    PubMed 38409644

  • Vijayakumar P, Liu S, McCoy RG, Karter AJ, Lipska KJ. Changes in Management of Type 2 Diabetes Before and After Severe Hypoglycemia. Diabetes Care. 2020 Nov;43(11):e188-e189. doi: 10.2337/dc20-0458. Epub 2020 Sep 17. No abstract available.

    PubMed 32943439

  • Zhao Y, Shi Q, Wang Y, Fonseca V, Shi L. Economic burden of hypoglycemia: Utilization of emergency department and outpatient services in the United States (2005-2009). J Med Econ. 2016 Sep;19(9):852-7. doi: 10.1080/13696998.2016.1178126. Epub 2016 May 4.

    PubMed 27074526

  • Lipska KJ, Ross JS, Wang Y, Inzucchi SE, Minges K, Karter AJ, Huang ES, Desai MM, Gill TM, Krumholz HM. National trends in US hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999 to 2011. JAMA Intern Med. 2014 Jul;174(7):1116-24. doi: 10.1001/jamainternmed.2014.1824.

    PubMed 24838229

Questions about this trial

What is this clinical trial studying?

A study testing Proactive population care (active application of HOAP principles in patients flagged as high risk for hypoglycemia) in people with Diabetes, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa K Gilliam, MD, PhD (650-676-7584, lisa.k.gilliam@kp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with sulfonylureas, mealtime, or mixed insulin discontinued (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06746714, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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