Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05916131
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Basic Education — BEHAVIORAL
    2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
  • Hypoglycemia Symptom Detection Training — BEHAVIORAL
    10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.
  • Education Plus — BEHAVIORAL
    10-week text message intervention for helping people consider how they think of hypoglycemia.

Study Details

A mobile health program "HypoPals", which incorporates data from continuous glucose monitoring systems (CGMs) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. The goal of the current study is to make sure that HypoPals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods). All participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: Hypoglycemia Symptom Detection Training, Education Plus, both Symptom Detection Training and Education Plus, and usual care. Participants may receive additional interventional text messages based on the experimental condition participants are assigned to. The study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).

Key Dates

Start date
Sep 19, 2023
Status verified
Jun 2025
Primary completion
Feb 2, 2024
Completion
Feb 12, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Hypoglycemia Symptom Detection Training
    To provide Hypoglycemia Symptom Detection Training intervention.
  • Experimental: Education Plus
    To provide Education Plus intervention.
  • Experimental: Hypoglycemia Symptom Detection Training and Education Plus
    To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.
  • Other: Usual Care
    Continuing usual care after basic education.

Primary Outcome Measure

The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention [ Time Frame: Approximately 4.5 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Michigan· Ann Arbor, MI

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