Clinical trial NCT06353217: Study of a Primary Care Hypoglycemia Prevention Program
Official title: Pilot Study of a Primary Care Hypoglycemia Prevention Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Hypoglycemia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-04-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre/post pilot study
Primary purpose: PREVENTION

Brief 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. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.


Eligibility criteria: Inclusion criteria for patients:

* 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

Exclusion criteria for patients:

* 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):

* History of allergic skin reaction to adhesive
* Implantable pacemaker

Inclusion criteria for primary care providers:

* Practicing at Johns Hopkins Internal Medicine Green Spring Station

Exclusion criteria for primary care providers:

* Planning to leave their position prior to end of study
* Not serving as primary care provider for any included patient

Inclusion criteria for clinic staff:

* Participating in check-in at Johns Hopkins Internal Medicine Green Spring Station

Exclusion criteria for clinic staff

* Planning to leave their position prior to end of study

Primary outcomes:
measure: Overall acceptability to patients
timeFrame: Immediately after the intervention
measure: Overall acceptability to primary care providers
timeFrame: Immediately after the intervention
measure: Overall acceptability to clinic staff
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
measure: Intervention coherence (patients)
timeFrame: Immediately after the intervention
measure: Opportunity costs (patients)
timeFrame: Immediately after the intervention
measure: Ethicality (patients)
timeFrame: Immediately after the intervention
measure: Affective attitude (patients)
timeFrame: Immediately after the intervention
measure: Burden (patients)
timeFrame: Immediately after the intervention
measure: Self-efficacy (patients)
timeFrame: Immediately after the intervention
measure: Perceived effectiveness (primary care providers)
timeFrame: Immediately after the intervention
measure: Intervention coherence (primary care providers)
timeFrame: Immediately after the intervention
measure: Opportunity costs (primary care providers)
timeFrame: Immediately after the intervention
measure: Affective attitude (primary care providers)
timeFrame: Immediately after the intervention
measure: Burden (primary care providers)
timeFrame: Immediately after the intervention
measure: Self-efficacy (primary care providers)
timeFrame: Immediately after the intervention
measure: Burden (clinic staff)
timeFrame: Immediately after the intervention
measure: Opportunity costs (clinic staff)
timeFrame: Immediately after the intervention
measure: Recruitment rate
timeFrame: Immediately after the intervention
measure: Retention rate for second clinic visit
timeFrame: Immediately after the intervention
measure: Continuous glucose monitoring (CGM) completion
timeFrame: Immediately after the final CGM measurement (4-12 weeks after the intervention)
measure: Continuous glucose monitoring (CGM) wear time
timeFrame: Immediately after the final CGM measurement (4-12 weeks after the intervention)
measure: Time needed to complete patient hypoglycemia profile
timeFrame: Immediately after completion of intervention clinic visit
measure: Duration of clinical visit
timeFrame: Change from baseline to immediately after completion of intervention clinic visit
measure: Patient completion of hypoglycemia assessment
timeFrame: Immediately after completion of intervention clinic visit
measure: Primary care provider use of provider hypoglycemia toolkit
timeFrame: Immediately after completion of intervention clinic visit
measure: Patient hypoglycemia burden on continuous glucose monitoring (CGM)
timeFrame: Baseline to post-intervention up to 12 weeks
measure: Patient time below range on continuous glucose monitoring (CGM)
timeFrame: Baseline to post-intervention up to 12 weeks
measure: Patient time above range on continuous glucose monitoring (CGM)
timeFrame: Baseline to post-intervention up to 12 weeks
measure: Patient mean glucose on continuous glucose monitoring (CGM)
timeFrame: Baseline to post-intervention up to 12 weeks
measure: Patient satisfaction with care
timeFrame: Change from baseline to immediately after the intervention
measure: Patient activation
timeFrame: Change from baseline to immediately after the intervention
measure: Patient self-reported hypoglycemic events
timeFrame: Change from baseline to 4-12 weeks after the intervention
measure: Changes to hypoglycemia-causing medications
timeFrame: Change from baseline to immediately after the intervention
measure: Glucagon prescription
timeFrame: Change from baseline to immediately after the intervention
measure: Continuous glucose monitoring (CGM) prescription
timeFrame: Change from baseline to immediately after the intervention
measure: Change in Frequency of Referrals to Diabetes Self Management Training (DSMT)
timeFrame: Change from baseline to immediately after the intervention
measure: Frequency of hypoglycemia history discussions
timeFrame: Change from baseline to immediately after the intervention
measure: Frequency of Hypoglycemia anticipatory guidance discussions
timeFrame: Change from baseline to immediately after the intervention
measure: Frequency of Medication adherence discussions
timeFrame: Change from baseline to immediately after the intervention
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Scott J Pilla, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: