Trial Outcomes & Findings for Comparing the Effectiveness of Two Approaches to Preventing Severe Hypoglycemia in Patients With Type 2 Diabetes (PHT2) (NCT NCT04863872)

NCT ID: NCT04863872

Last Updated: 2025-05-06

Results Overview

Any self-reported severe hypoglycemia in prior 12 months

Recruitment status

COMPLETED

Study phase

Target enrollment

259 participants

Primary outcome timeframe

14 months

Results posted on

2025-05-06

Participant Flow

Participants were enrolled based on identification from the Electronic Medical Record followed by outreach and telephone screening from January 2022 to January 2023. The first participant was enrolled on January 26, 2022 and the last participant was enrolled in January 2023.

Participant milestones

Participant milestones
Measure	Proactive Care Management Proactive Care Management: 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 + MyHC-T2D Education Program Proactive Care Management: 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 program: 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.
Overall Study STARTED	129	130
Overall Study COMPLETED	118	112
Overall Study NOT COMPLETED	11	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Proactive Care Management Proactive Care Management: 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 + MyHC-T2D Education Program Proactive Care Management: 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 program: 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.
Overall Study Withdrawal by Subject	4	15
Overall Study Death	5	2
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proactive Care Management n=129 Participants Proactive Care Management: 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 + MyHC-T2D Education Program n=130 Participants Proactive Care Management: 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 program: 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.	Total n=259 Participants Total of all reporting groups
Age, Customized Age, categorical · Age less than 75 years	92 Participants n=5 Participants	92 Participants n=7 Participants	184 Participants n=5 Participants
Age, Customized Age, categorical · Age 75 years and older	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	81 Participants n=7 Participants	157 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	49 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants n=5 Participants	122 Participants n=7 Participants	246 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	99 Participants n=5 Participants	102 Participants n=7 Participants	201 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Hypoglycemic risk score Low	60 Participants n=5 Participants	61 Participants n=7 Participants	121 Participants n=5 Participants
Hypoglycemic risk score Moderate	60 Participants n=5 Participants	61 Participants n=7 Participants	121 Participants n=5 Participants
Hypoglycemic risk score High	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Impaired awareness of hypoglycemia No impaired awareness	24 Participants n=5 Participants	12 Participants n=7 Participants	36 Participants n=5 Participants
Impaired awareness of hypoglycemia Impaired awareness	104 Participants n=5 Participants	118 Participants n=7 Participants	222 Participants n=5 Participants
Impaired awareness of hypoglycemia Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Self report of any severe hypoglycemia in past 12 months Zero	85 Participants n=5 Participants	97 Participants n=7 Participants	182 Participants n=5 Participants
Self report of any severe hypoglycemia in past 12 months One or more	44 Participants n=5 Participants	32 Participants n=7 Participants	76 Participants n=5 Participants
Self report of any severe hypoglycemia in past 12 months Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 months

Population: Participants included who completed the 14-month survey.

Any self-reported severe hypoglycemia in prior 12 months

Outcome measures

Outcome measures
Measure	Proactive Care Management n=118 Participants Proactive Care Management: 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 + MyHC-T2D Education Program n=112 Participants Proactive Care Management: 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 program: 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.
Self-reported Severe Hypoglycemia Zero	99 Participants	99 Participants
Self-reported Severe Hypoglycemia One or more	19 Participants	13 Participants

Adverse Events

Proactive Care Management

Serious events: 46 serious events

Other events: 39 other events

Deaths: 5 deaths

Proactive Care Management + MyHC-T2D Education Program

Serious events: 56 serious events

Other events: 54 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Proactive Care Management n=129 participants at risk Proactive Care Management: 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 + MyHC-T2D Education Program n=130 participants at risk Proactive Care Management: 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 program: 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.
Infections and infestations COVID-19	7.0% 9/129 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.	9.2% 12/130 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.
Injury, poisoning and procedural complications Fall	6.2% 8/129 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.	5.4% 7/130 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.
Skin and subcutaneous tissue disorders Itching with Continuous glucose monitor	3.9% 5/129 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.	7.7% 10/130 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.
Endocrine disorders Hypoglycemia	3.9% 5/129 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.	6.2% 8/130 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.
Skin and subcutaneous tissue disorders Bleeding with Continuous glucose monitor	1.6% 2/129 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.	7.7% 10/130 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.
Skin and subcutaneous tissue disorders Discomfort with Continuous Glucose Monitor	3.9% 5/129 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.	3.8% 5/130 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.
Nervous system disorders Confusion	3.9% 5/129 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.	1.5% 2/130 • Self-reported adverse events were collected over 14 months from the time of the baseline survey through 14-month follow up. If a participant experienced an adverse event after informed consent was completed but before the participant started to receive the study intervention, the event was recorded and reported, but was determined as not related to the study intervention. Adverse events were collected using self-report open-ended survey questions at 6-, 10- and 14-month follow-up, and an open-ended question "Did you experience any difficulties with the Continuous Glucose Monitor (CGM)" after CGM data collection at baseline and 14 months. Study staff also recorded any adverse events reported spontaneously during scheduling calls. There were no differences between the ClinicalTrials.gov definitions and those used for this study.

Additional Information

James Ralston, MD, MPH

Kaiser Permanente Washington Health Research Institute

Phone: 206-287-2076

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place