Severe HypoglycemiaPHT2NCT04863872
Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2)
A study testing Proactive Care Management and MyHC-T2D education program in people with Severe Hypoglycemia, run by Kaiser Permanente at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Hypoglycemia
- What is being tested?
- Proactive Care Management and MyHC-T2D education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia
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:
Read more
- 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.
- 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.
Our hypothesis is that proactive care management plus MyHC-T2D will be more effective than proactive care management alone at preventing self-reported severe hypoglycemia in adults with type 2 diabetes at high risk for severe hypoglycemia. The primary outcome will be measured using surveys at the beginning of the study and 14-months later.
Read the detailed description
This study is a two-arm, individually-randomized, comparative effectiveness study of two evidence-based approaches to preventing severe hypoglycemia. We will identify participants using Electronic Health Record (EHR) data. They will be identified for potential recruitment if they are age 18 and older, diagnosed with type 2 diabetes, receiving primary care at Kaiser Permanente Washington and have a current prescription for insulin or identified using an EHR-based risk stratification tool as being at intermediate to high risk for a severe hypoglycemia event. Within this population, we will recruit participants who either have impaired awareness of hypoglycemia or self-report a severe hypoglycemia event in the prior 12 months. Participants must be members of Kaiser Permanente Washington and identified by the study.
Following randomization, we will compare patients who receive proactive care management from nurses to patients receiving proactive care management plus MyHC-T2D, a structured educational intervention that reduces the frequency of severe hypoglycemia in individuals with type 1 diabetes. In both groups, we will use proactive care management to assess and provide evidence-based care for impaired awareness of hypoglycemia and other potential contributors to severe hypoglycemia risk.
Our primary outcome is participant-reported severe hypoglycemia, to capture all events, including those not involving clinical care. We will also examine biochemical measures of hypoglycemia measured using continuous glucose monitoring (CGM), participant-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. We will conduct a process evaluation to assess the fidelity of implementation and clarify the causal pathway.
- Conditions
- Severe Hypoglycemia
- Being tested
- Proactive Care Management, MyHC-T2D education program
- Keywords
- Hypoglycemia, Self-management, Diabetes Mellitus, Type 2, Patient Education
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Care ManagementOther
Participants will receive one telephone nurse outreach call with follow up by the nurse or their primary care provider as clinically indicated.
MyHC-T2D education programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Proactive Care Management; Behavioral: MyHC-T2D education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Severe Hypoglycemia
Any self-reported severe hypoglycemia in prior 12 months
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start26 Jan 2022
- Primary completion24 Apr 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- James Ralston, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863872
- Sponsor's protocol ID
- IHS-2019C3-17889
- Acronym
- PHT2
- Status last verified
- May 2025
- First submitted
- 26 Apr 2021
- Last updated
- 6 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28828479Gold 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.
PubMed 7924780Fitzgerald 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.
PubMed 10186911Ralston JD, Anderson ML, 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, Speight J, Sweeny A, Tschernisch K, Tschernisch S, Yarborough L. Preventing Severe Hypoglycemia in Type 2 Diabetes: Randomized Controlled Trial of Proactive Care With Versus Without Psychoeducation. J Gen Intern Med. 2026 May 12. doi: 10.1007/s11606-026-10491-7. Online ahead of print.
PubMed 42118187Ralston 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.
PubMed 38253252
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia
- ClinicalTrials.gov ID
- NCT04863872
- Acronym / sponsor ID
- PHT2 / IHS-2019C3-17889
- Conditions
- Severe Hypoglycemia
- Keywords
- Hypoglycemia, Self-management, Diabetes Mellitus, Type 2, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Our hypothesis is that proactive care management plus MyHC-T2D will be more effective than proactive care management alone at preventing self-reported severe hypoglycemia in adults with type 2 diabetes at high risk for severe hypoglycemia. The primary outcome will be measured using surveys at the beginning of the study and 14-months later.
Detailed description
This study is a two-arm, individually-randomized, comparative effectiveness study of two evidence-based approaches to preventing severe hypoglycemia. We will identify participants using Electronic Health Record (EHR) data. They will be identified for potential recruitment if they are age 18 and older, diagnosed with type 2 diabetes, receiving primary care at Kaiser Permanente Washington and have a current prescription for insulin or identified using an EHR-based risk stratification tool as being at intermediate to high risk for a severe hypoglycemia event. Within this population, we will recruit participants who either have impaired awareness of hypoglycemia or self-report a severe hypoglycemia event in the prior 12 months. Participants must be members of Kaiser Permanente Washington and identified by the study.
Following randomization, we will compare patients who receive proactive care management from nurses to patients receiving proactive care management plus MyHC-T2D, a structured educational intervention that reduces the frequency of severe hypoglycemia in individuals with type 1 diabetes. In both groups, we will use proactive care management to assess and provide evidence-based care for impaired awareness of hypoglycemia and other potential contributors to severe hypoglycemia risk.
Our primary outcome is participant-reported severe hypoglycemia, to capture all events, including those not involving clinical care. We will also examine biochemical measures of hypoglycemia measured using continuous glucose monitoring (CGM), participant-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. We will conduct a process evaluation to assess the fidelity of implementation and clarify the causal pathway.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Proactive Care Management | Active comparator | Other: Proactive Care ManagementParticipants will receive one telephone nurse outreach call with follow up by the nurse or their primary care provider as clinically indicated. |
| Proactive Care Management + MyHC-T2D education program | Experimental | Other: Proactive Care Management, Behavioral: MyHC-T2D education programParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive Care ManagementParticipants 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 |
| MyHC-T2D education programParticipants 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. | Behavioural | Proactive Care Management + MyHC-T2D education program |
Primary outcome
Self-reported Severe Hypoglycemia
Time frame: 14 months
Any self-reported severe hypoglycemia in prior 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28828479Karter 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.
- Background: PubMed 7924780Gold 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.
- Background: PubMed 10186911Fitzgerald 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.
- Derived from this study: PubMed 42118187Ralston JD, Anderson ML, 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, Speight J, Sweeny A, Tschernisch K, Tschernisch S, Yarborough L. Preventing Severe Hypoglycemia in Type 2 Diabetes: Randomized Controlled Trial of Proactive Care With Versus Without Psychoeducation. J Gen Intern Med. 2026 May 12. doi: 10.1007/s11606-026-10491-7. Online ahead of print.
- Derived from this study: PubMed 38253252Ralston 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.
- Individual participant dataSharing planned: No
Related trials for Severe Hypoglycemia
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
RecruitingPhase 3
A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness
RecruitingPhase 1/2
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1, Hypoglycemia
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
RecruitingPhase 1/2
A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1, Impaired Hypoglycemic Awareness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ralston, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Care Management and MyHC-T2D education program in people with Severe Hypoglycemia, 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 6 May 2025. 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?
Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Severe Hypoglycemia (time frame: 14 months). 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 NCT04863872, which also lists 5 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 6 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.