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CompletedNCT03665870Updated Jul 22, 2020

Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia

An interventional study of Hypoglycemia Education in Diabetes Mellitus, Hypoglycemia Unawareness and Hypoglycemia, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study summary

This study aims to standardize and evaluate the benefits of the Prevention to Intervention program offered by the Birmingham Fire and Rescue Service. This will accomplished by standardizing the educational materials used, offering phone based follow-up and pre-post data collection.

02

Conditions studied

  • Diabetes Mellitus
  • Hypoglycemia Unawareness
  • Hypoglycemia
  • Hypoglycemia Acute

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Keywords

  • Telehealth
  • Emergency Medicine
  • Paramedicine
  • Diabetes
  • Hypoglycemia
  • Telecoaching
03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 50 is above the median of 29 across 471 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Be a citizen of Birmingham
  2. Be 18 years or older
  3. Receive Dextrose-50 IV (intravenous treatment provided by EMS personnel for hypoglycemia)
  4. Understand and speak English

Exclusion criteria

Exclusion Criteria:

a) Enrolled currently in any diabetes related educational programs

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Intervention Arm

    Hypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia.

    Behavioral: Hypoglycemia Education

Interventions

  • BehavioralHypoglycemia Education

    Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.

06

What researchers measure

Primary outcomes

  1. Fear of Hypoglycemia

    One of the most important impact of hypoglycemia, is non-compliance to diabetes treatment due to the fear of hypoglycemia. This would be measured using the "Hypoglycemia Scale: FH-15" scale.

    Time frame: Through study completion, an average of 8 weeks

Secondary outcomes

  1. Self Efficacy

    Measured using the "Perceived Diabetes Self-Management Scale".

    Time frame: Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks

  2. Knowledge of Diabetes

    Measured using the "The Knowledge in Low Literacy in Diabetes Knowledge Assessment Scale"

    Time frame: Through study completion, an average of 8 weeks

07

Study locations

1 site
  • Birmingham Fire and Rescue Service
    Birmingham, Alabama 35209, United States
08

References and documents

Publications

  • Thirumalai M, Zengul AG, Evans E. Challenges and Lessons Learned From a Telehealth Community Paramedicine Program for the Prevention of Hypoglycemia: Pre-Post Pilot Feasibility Study. JMIR Diabetes. 2021 Aug 3;6(3):e26941. doi: 10.2196/26941. PubMed 34342593 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03665870
Lead sponsor
University of Alabama at Birmingham
Collaborators
Birmingham Fire and Rescue Service
Responsible party
Mohanraj Thirumalai (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Sep 11, 2018
Start date
Oct 1, 2018
Primary completion
May 24, 2020
Completion
Jul 20, 2020
Last update
Jul 22, 2020

Study contacts

Mohanraj Thirumalai, PhD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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