Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

NCT06746714 | Completed

• 1 other identifier: IRBNetID: 1980653
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes

Keywords

hypoglycemia; population management; clinical guideline

Outcome Measures

Primary Outcomes (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)

  6 months

Secondary Outcomes (4)

• Number of participants prescribed CGM

  6 months

• Number of participants prescribed glucagon

  6 months

• Number of participants with A1c <8%

  6 months

• Number of participants with ED visit or hospitalization for hypoglycemia

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group, receiving protocol-driven outreach by a clinical pharmacist (the "hypoglycemia champion", or HC) to hypoglycemia-prone patients with T2D

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

Usual care group

ACTIVE COMPARATOR

Usual care, after system-wide dissemination of HOAP

Behavioral: Usual care, after system-side dissemination of HOAP

Interventions

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

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.

Intervention group

Usual care, after system-side dissemination of HOAP BEHAVIORAL

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

Usual care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• deceased,
• enrolled in concurrent pharmacy deprescribing pilots

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Department of Research

Pleasanton, California, 94588, United States

Location

Related Publications (17)

• 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.

  PMID: 28828479 BACKGROUND

• 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.

  PMID: 29292555 BACKGROUND

• 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.

  PMID: 23193215 BACKGROUND

• 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.

  PMID: 26078413 BACKGROUND

• 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.

  PMID: 19500161 BACKGROUND

• 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.

  PMID: 18326513 BACKGROUND

• 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.

  PMID: 31347983 BACKGROUND

• 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.

  PMID: 35550730 BACKGROUND

• 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.

  PMID: 35151583 BACKGROUND

• 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.

  PMID: 15839185 BACKGROUND

• 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.

  PMID: 23900589 BACKGROUND

• 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.

  PMID: 38409644 BACKGROUND

• 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.

  PMID: 32943439 BACKGROUND

• 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.

  PMID: 27074526 BACKGROUND

• 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.

  PMID: 24838229 BACKGROUND

• Shehab N, Lovegrove MC, Geller AI, Rose KO, Weidle NJ, Budnitz DS. US Emergency Department Visits for Outpatient Adverse Drug Events, 2013-2014. JAMA. 2016 Nov 22;316(20):2115-2125. doi: 10.1001/jama.2016.16201.

  PMID: 27893129 BACKGROUND

• Karter AJ, Moffet HH, Liu JY, Lipska KJ. Surveillance of Hypoglycemia-Limitations of Emergency Department and Hospital Utilization Data. JAMA Intern Med. 2018 Jul 1;178(7):987-988. doi: 10.1001/jamainternmed.2018.1014.

  PMID: 29710182 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lisa K Gilliam, MD, PhD

  The Permanente Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endocrinology, South San Francisco Medical Center

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 24, 2024
• Study Start: July 20, 2023
• Primary Completion: July 22, 2024
• Study Completion: December 20, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)