Diabetes MellitusNCT06353217
Study of a Primary Care Hypoglycemia Prevention Program
A study testing Patient Group (Hypoglycemia Prevention Program), Primary Care Physician Group and Clinic Staff Group in people with Diabetes Mellitus and Hypoglycemia, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypoglycemia
- What is being tested?
- Patient Group (Hypoglycemia Prevention Program), Primary Care Physician Group and Clinic Staff Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diabetes mellitus by electronic health record review
- Treatment with any of the following medication classes: insulin, sulfonylureas, meglitinides
- Community dwelling (not residing in long-term care or a skilled nursing facility)
- Receiving primary care from a participating primary care provider at Johns Hopkins Internal Medicine at Green Spring Station
- The patient's primary care provider approves their participation
- Practicing at Johns Hopkins Internal Medicine Green Spring Station
- Participating in check-in at Johns Hopkins Internal Medicine Green Spring Station
Who cannot join
- Significant cognitive impairment or dementia
- Receiving hospice or end of life care
- Any other serious illness or condition not compatible with participation as determined by the investigators
- Planning to leave area prior to end of study
- Investigator discretion
- Exclusion Criteria for continuous glucose monitoring (not required for study participation):
Show all 11Show fewer
- History of allergic skin reaction to adhesive
- Implantable pacemaker
- Planning to leave their position prior to end of study
- Not serving as primary care provider for any included patient
- Planning to leave their position prior to end of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Pilot Study of a Primary Care Hypoglycemia Prevention Program
This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.
- Conditions
- Diabetes Mellitus, Hypoglycemia
- Being tested
- Patient Group (Hypoglycemia Prevention Program), Primary Care Physician Group, Clinic Staff Group
- 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.
Patient Group (Hypoglycemia Prevention Program)Other
The Hypoglycemia Prevention Program:
The patient hypoglycemia profile - this is a set of survey questions about hypoglycemia and related aspects of diabetes care. The questions will be administered as an Epic MyChart message sent to the patient in the week prior to the clinic visit, and in the clinic waiting room on a tablet immediately prior to the patient's primary care provider visit.
Primary Care Physician GroupOther
The provider hypoglycemia toolkit - this is the report from the patient hypoglycemia profile, which triggers a set of hypoglycemia prevention tools and patient education materials as appropriate. Primary Care Providers will not be exposed to the intervention until all of their patients have completed the Baseline Clinic Visit.
Clinic Staff GroupOther
Clinic staff will provide the tablet to the participant immediately prior to the patient's primary care provider visit.
| Study group | Role | What they receive |
|---|---|---|
| Primary care hypoglycemia prevention program | Other | Not described Receives: Other: Patient Group (Hypoglycemia Prevention Program); Other: Primary Care Physician Group; Other: Clinic Staff Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall acceptability to patients
Mean score for overall acceptability on patient intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Measured: Immediately after the intervention
Overall acceptability to primary care providers
Mean score for overall acceptability on primary care provider intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Measured: Immediately after the intervention
Overall acceptability to clinic staff
Mean score for overall acceptability on clinic staff intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start22 May 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre/post pilot study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott J Pilla, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353217
- Sponsor's protocol ID
- IRB00419034
- Other IDs
- K23DK128572
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Primary Care Hypoglycemia Prevention Program
- ClinicalTrials.gov ID
- NCT06353217
- Acronym / sponsor ID
- IRB00419034
- Conditions
- Diabetes Mellitus, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 May 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/post pilot study
| Arm | Type | Receives |
|---|---|---|
| Primary care hypoglycemia prevention program | Other | Other: Patient Group (Hypoglycemia Prevention Program), Other: Primary Care Physician Group, Other: Clinic Staff Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Diabetes mellitus by electronic health record review
- Treatment with any of the following medication classes: insulin, sulfonylureas, meglitinides
- Community dwelling (not residing in long-term care or a skilled nursing facility)
- Receiving primary care from a participating primary care provider at Johns Hopkins Internal Medicine at Green Spring Station
Key exclusion criteria (11 listed)
- Significant cognitive impairment or dementia
- Receiving hospice or end of life care
- Any other serious illness or condition not compatible with participation as determined by the investigators
- Planning to leave area prior to end of study
- Investigator discretion
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 |
|---|---|---|
| Patient Group (Hypoglycemia Prevention Program)The Hypoglycemia Prevention Program: The patient hypoglycemia profile - this is a set of survey questions about hypoglycemia and related aspects of diabetes care. The questions will be administered as an Epic MyChart message sent to the patient in the week prior to the clinic visit, and in the clinic waiting room on a tablet immediately prior to the patient's primary care provider visit. | Other | Primary care hypoglycemia prevention program |
| Primary Care Physician GroupThe provider hypoglycemia toolkit - this is the report from the patient hypoglycemia profile, which triggers a set of hypoglycemia prevention tools and patient education materials as appropriate. Primary Care Providers will not be exposed to the intervention until all of their patients have completed the Baseline Clinic Visit. | Other | Primary care hypoglycemia prevention program |
| Clinic Staff GroupClinic staff will provide the tablet to the participant immediately prior to the patient's primary care provider visit. | Other | Primary care hypoglycemia prevention program |
Primary outcome
Overall acceptability to patients
Time frame: Immediately after the intervention
Mean score for overall acceptability on patient intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Overall acceptability to primary care providers
Time frame: Immediately after the intervention
Mean score for overall acceptability on primary care provider intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Overall acceptability to clinic staff
Time frame: Immediately after the intervention
Mean score for overall acceptability on clinic staff intervention evaluation survey (developed for this study, range 1-completely unacceptable, to 5-completely acceptable)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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.
Scott J Pilla, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Group (Hypoglycemia Prevention Program), Primary Care Physician Group and Clinic Staff Group in people with Diabetes Mellitus and Hypoglycemia, run by Johns Hopkins University 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 8 inclusion and 11 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 9 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall acceptability to patients (time frame: Immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2026.