Skip to main content
OpenTrials
Completed

NCT Number: NCT06353217

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Group

Other

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 Group

Other

Clinic staff will provide the tablet to the participant immediately prior to the patient's primary care provider visit.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Other outcomes

  1. Intervention coherence (patients)

    Time frame: Immediately after the intervention

    Mean score for intervention coherence on patient intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)

  2. Opportunity costs (patients)

    Time frame: Immediately after the intervention

    Mean score for opportunity costs on patient intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)

  3. Ethicality (patients)

    Time frame: Immediately after the intervention

    Mean score for ethicality on patient intervention evaluation survey (developed for this study, range 1-very unfair, to 5-very fair)

  4. Affective attitude (patients)

    Time frame: Immediately after the intervention

    Mean score for affective attitude on patient intervention evaluation survey (developed for this study, range 1-very uncomfortable, to 5-very comfortable)

  5. Burden (patients)

    Time frame: Immediately after the intervention

    Mean score for burden on patient intervention evaluation survey (developed for this study, range 1-no effort at all, to 5-huge effort)

  6. Self-efficacy (patients)

    Time frame: Immediately after the intervention

    Mean score for self-efficacy on patient intervention evaluation survey (developed for this study, range 1-very un-confident, to 5-very confident)

  7. Perceived effectiveness (primary care providers)

    Time frame: Immediately after the intervention

    Mean score for perceived effectiveness on primary care provider intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)

  8. Intervention coherence (primary care providers)

    Time frame: Immediately after the intervention

    Mean score for intervention coherence on primary care provider intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)

  9. Opportunity costs (primary care providers)

    Time frame: Immediately after the intervention

    Mean score for opportunity costs on primary care provider intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)

  10. Ethicality (primary care providers)

    Time frame: Immediately after the intervention

    Mean score for ethicality on patient intervention evaluation survey (developed for this study, range 1-very unfair, to 5-very fair)

  11. Affective attitude (primary care providers)

    Time frame: Immediately after the intervention

    Mean score for affective attitude on primary care provider intervention evaluation survey (developed for this study, range 1-very uncomfortable, to 5-very comfortable)

  12. Burden (primary care providers)

    Time frame: Immediately after the intervention

    Mean score for burden on primary care provider intervention evaluation survey (developed for this study, range 1-no effort at all, to 5-huge effort)

  13. Self-efficacy (primary care providers)

    Time frame: Immediately after the intervention

    Mean score for self-efficacy on primary care provider intervention evaluation survey (developed for this study, range 1-Very unconfident, to 5-very confident)

  14. Intervention coherence (clinic staff)

    Time frame: Immediately after the intervention

    Mean score for intervention coherence on patient intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)

  15. Opportunity costs (clinic staff)

    Time frame: Immediately after the intervention

    Mean score for opportunity costs on clinic staff intervention evaluation survey (developed for this study, range 1-strongly disagree, to 5-strongly agree)

  16. Ethicality (clinic staff)

    Time frame: Immediately after the intervention

    Mean score for ethicality on patient intervention evaluation survey (developed for this study, range 1-very unfair, to 5-very fair)

  17. Affective attitude (clinic staff)

    Time frame: Immediately after the intervention

    Mean score for affective attitude on patient intervention evaluation survey (developed for this study, range 1-very uncomfortable, to 5-very comfortable)

  18. Burden (clinic staff)

    Time frame: Immediately after the intervention

    Mean score for burden on clinic staff intervention evaluation survey (developed for this study, range 1-no effort at all, to 5-huge effort)

  19. Self-efficacy (clinic staff)

    Time frame: Immediately after the intervention

    Mean score for self-efficacy on patient intervention evaluation survey (developed for this study, range 1-very un-confident, to 5-very confident)

  20. Recruitment rate

    Time frame: Immediately after the intervention

    % of eligible participants who consented to participate

  21. Retention rate for second clinic visit

    Time frame: Immediately after the intervention

    % of participants who completed two clinic visits

  22. Continuous glucose monitoring (CGM) completion

    Time frame: Immediately after the final CGM measurement (4-12 weeks after the intervention)

    % of participants who completed CGM measurements

  23. Continuous glucose monitoring (CGM) wear time

    Time frame: Immediately after the final CGM measurement (4-12 weeks after the intervention)

    Mean days with complete CGM data

  24. Time needed to complete patient hypoglycemia profile

    Time frame: Immediately after completion of intervention clinic visit

    Mean completion time (minutes) for patient hypoglycemia profile

  25. Duration of clinical visit

    Time frame: Change from baseline to immediately after completion of intervention clinic visit

    Change from baseline in mean duration of clinic visit (minutes)

  26. Patient completion of hypoglycemia assessment

    Time frame: Immediately after completion of intervention clinic visit

    Completion rate overall and for individual items

  27. Primary care provider use of provider hypoglycemia toolkit

    Time frame: Immediately after completion of intervention clinic visit

    Rate of toolkit use overall and for individual tools

  28. Patient hypoglycemia burden on continuous glucose monitoring (CGM)

    Time frame: Baseline to post-intervention up to 12 weeks

    Change from baseline in mean minutes per day with glucose <70 mg/dl and <54 mg/dl

  29. Patient time below range on continuous glucose monitoring (CGM)

    Time frame: Baseline to post-intervention up to 12 weeks

    Change from baseline in % time with glucose <70 mg/dl

  30. Patient time above range on continuous glucose monitoring (CGM)

    Time frame: Baseline to post-intervention up to 12 weeks

    Change from baseline in % time with glucose >180 mg/dl

  31. Patient mean glucose on continuous glucose monitoring (CGM)

    Time frame: Baseline to post-intervention up to 12 weeks

    Change from baseline in mean glucose

  32. Patient satisfaction with care

    Time frame: Change from baseline to immediately after the intervention

    Change from baseline in mean score on The Patient Satisfaction Questionnaire Short Form (PSQ-18), range 1 (lowest satisfaction) to 5 (highest satisfaction) in 7 domains

  33. Patient activation

    Time frame: Change from baseline to immediately after the intervention

    Change from baseline in mean score on Patient Activation Measure (PAM 10), range 0 (lowest activation) to 100 (highest activation)

  34. Patient self-reported hypoglycemic events

    Time frame: Change from pre-intervention to 4-12 weeks after the intervention

    Change from baseline in frequency of level 1, level 2, and level 3 hypoglycemia events on hypoglycemia history survey

  35. Changes to hypoglycemia-causing medications

    Time frame: Change from baseline to immediately after the intervention

    % of patients with changes in diabetes medications (dose increase, decrease, stop, switch, initiate)

  36. Glucagon prescription

    Time frame: Change from baseline to immediately after the intervention

    % of patients with active glucagon prescription

  37. Continuous glucose monitoring (CGM) prescription

    Time frame: Change from baseline to immediately after the intervention

    Change from baseline in frequency of CGM prescription

  38. Frequency of hypoglycemia history discussions

    Time frame: Change from baseline to immediately after the intervention

    Frequency and content of hypoglycemia history discussion by audio-recording

  39. Frequency of Hypoglycemia anticipatory guidance discussions

    Time frame: Change from baseline to immediately after the intervention

    Frequency, content, and accuracy of hypoglycemia anticipatory guidance

  40. Frequency of Medication adherence discussions

    Time frame: Change from baseline to immediately after the intervention

    Frequency and content of discussions of adherence to diabetes medications

  41. Hemoglobin A1c

    Time frame: Pre-intervention up to 220 days post intervention

    Change in hemoglobin A1c level from electronic health record, from before the intervention visit (most recent value within 6 months) to the next value >60 days after the intervention visit.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Pilot Study of a Primary Care Hypoglycemia Prevention Program

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.