Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)

NCT04863872 | Completed Results DMC

• 1 other identifier: IHS-2019C3-17889
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

Severe hypoglycemia is the most feared complication of medications used to lower blood glucose levels in patients with diabetes. Severe hypoglycemia, defined as plasma glucose low enough to require assistance, has been linked to poor health-related quality of life, emotional and interpersonal challenges, car accidents, serious falls, cardiovascular events, dementia, and death. Older adults with type 2 diabetes are particularly vulnerable to the complications of severe hypoglycemia. Each year, approximately 11% of patients with type 2 diabetes self-report severe hypoglycemia episodes. An estimated 14% of emergency hospitalizations of older Americans for adverse drug events implicate insulin and 11% implicate oral hypoglycemic agents. One in four diabetes-related hospital admissions is for hypoglycemia. This study will compare two ways to reduce severe hypoglycemia in people with type 2 diabetes. The two methods to be compared are:

1. 1.Proactive care management. This will be a nurse outreach call which is similar to the usual care that people with type 2 diabetes get to reduce their risk of severe hypoglycemia, but given in advance rather than in response to a recent severe hypoglycemia event.
2. 2.The same proactive care management (nurse outreach call) plus enrollment in MyHC-T2D, a health education program aimed at improving awareness of hypoglycemia and preventing severe hypoglycemia. This program has been shown to reduce severe hypoglycemia in people with type 1 diabetes but has not been tested in persons with type 2.

Conditions

Severe Hypoglycemia

Keywords

Hypoglycemia; Self-management; Diabetes Mellitus, Type 2; Patient Education

Outcome Measures

Primary Outcomes (1)

• Self-reported Severe Hypoglycemia

  Any self-reported severe hypoglycemia in prior 12 months

  14 months

Study Arms (2)

Proactive Care Management

ACTIVE COMPARATOR

Participants will receive one telephone nurse outreach call with follow up by the nurse or their primary care provider as clinically indicated.

Other: Proactive Care Management

Proactive Care Management + MyHC-T2D education program

EXPERIMENTAL

Participants will receive the same telephone nurse outreach call with follow up as clinically indicated as the comparator arm and will in in additional be enrolled in a structured education program designed to improve hypoglycemia awareness and reduce severe hypoglycemia. The structured program will include 2 online group education sessions, 2 nurse follow up calls and use of glucose and hypoglycemia diaries, delivered over approximately 3 months.

Other: Proactive Care Management; Behavioral: MyHC-T2D education program

Interventions

Proactive Care Management OTHER

Participants will receive one telephone nurse outreach call with follow up by the nurse or their primary care provider as clinically indicated.

Proactive Care Management; Proactive Care Management + MyHC-T2D education program

MyHC-T2D education program BEHAVIORAL

Participants will be enrolled in a structured education program designed to improve hypoglycemia awareness and reduce severe hypoglycemia. The structured program will include 2 online group education sessions, 2 nurse follow up calls and use of glucose and hypoglycemia diaries, delivered over approximately 3 months.

Proactive Care Management + MyHC-T2D education program

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Diagnosed with type 2 diabetes
• Receiving primary care at Kaiser Permanente Washington (KPWA)
• Enrollment in KPWA at baseline and planning to stay with a KPWA health plan for the next 6 months
• Current prescription for insulin or at intermediate to high risk for severe hypoglycemia episode using the hypoglycemia risk stratification tool developed by Karter et. al.
• History of severe hypoglycemia in the prior 12 months or impaired awareness of hypoglycemia

You may not qualify if:

• Inability to give informed consent
• Unable to speak or read English
• Inability or unwillingness to attend online or telephone educational sessions, follow up calls, or to complete outcome assessments
• Prior diagnosis of dementia, severe psychiatric conditions with psychosis, severe cognitive impairment
• Currently living in a nursing home or under hospice care
• Current use at baseline of Continuous Glucose Monitor
• Pregnant or planning to become pregnant

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

• 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

• Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care. 1994 Jul;17(7):697-703. doi: 10.2337/diacare.17.7.697.

  PMID: 7924780 BACKGROUND

• Fitzgerald JT, Davis WK, Connell CM, Hess GE, Funnell MM, Hiss RG. Development and validation of the Diabetes Care Profile. Eval Health Prof. 1996 Jun;19(2):208-30. doi: 10.1177/016327879601900205.

  PMID: 10186911 BACKGROUND

• Ralston JD, Anderson M, Ng J, Bashir A, Ehrlich K, Burns-Hunt D, Cotton M, Hansell L, Hsu C, Hunt H, Karter AJ, Levy SM, Ludman E, Madziwa L, Omura EM, Rogers K, Sevey B, Shaw JAM, Shortreed SM, Singh U, Speight J, Sweeny A, Tschernisch K, Sergei Tschernisch S, Yarborough L. Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial. Contemp Clin Trials. 2024 Apr;139:107456. doi: 10.1016/j.cct.2024.107456. Epub 2024 Jan 20.

  PMID: 38253252 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Both study groups received an intervention. Comparison to a group receiving usual care may have found different results. The proportion of individuals reporting a severe hypoglycemic event in the 12 months prior to baseline limited the ability to detect a change in the outcome at 14 months.

Results Point of Contact

• Title: James Ralston, MD, MPH
• Organization: Kaiser Permanente Washington Health Research Institute

James.D.Ralston@kp.org

206-287-2076

Study Officials

• James Ralston, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm randomized controlled trial comparing the effectiveness of 2 approaches for preventing severe hypoglycemia among participants with type 2 diabetes who are at risk for severe hypoglycemia. Participants were randomly assigned to one of two interventions: 1) Proactive Care Management, consisting of outreach from Kaiser Permanente Washington (KPWA) nurses using standard KPWA clinical tools; 2) the same Proactive Care Management plus MyHC-T2D, a structured educational intervention.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: January 26, 2022
• Primary Completion: April 24, 2024
• Study Completion: June 21, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)