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Mobile Health Program for Low Blood Sugar Management

N/A
Waitlist Available
Led By Yu Kuei Alex Lin, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reported diagnosis of type 1 diabetes for at least 5 years
Be older than 18 years old
Must not have
Untreated adrenal insufficiency or hypothyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year (recruitment period)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a mobile health program ("HypoPals") that sends personalized texts to help people detect low blood sugar & consider how they think of it. It will randomize participants to receive basic hypoglycemia education texts, Symptom Detection Training, or both.

Who is the study for?
This trial is for people with Type 1 Diabetes who've had severe low blood sugar in the past year or frequent low sugars, use a Dexcom CGM regularly, have completed diabetes education, and can read English texts. They should be willing to share glucose data and not be pregnant or planning pregnancy soon, have untreated hormonal issues, uncontrolled mental disorders, cognitive dysfunctions or be in other diabetes studies.
What is being tested?
The 'HypoPals' mobile health program uses continuous glucose monitoring data to send personalized texts aiming to improve hypoglycemia management. Participants will get basic education messages plus additional training based on their group assignment after being randomly placed into one of four groups: detection training only, advanced education only, both trainings or usual care.
What are the potential side effects?
Since this study involves educational text messages rather than medication there are no direct medical side effects; however participants may experience stress from increased attention to their condition or frustration if technical issues occur with the mobile health program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had type 1 diabetes for at least 5 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have untreated adrenal or thyroid issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year (recruitment period)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year (recruitment period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of participants recruited to reach 20 participants that complete the intervention
Secondary study objectives
Percentage of participants finding message content helpful (positive) at the end of the intervention

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Continuing usual care after basic education.
Group II: Hypoglycemia Symptom Detection Training and Education PlusExperimental Treatment3 Interventions
To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.
Group III: Hypoglycemia Symptom Detection TrainingExperimental Treatment2 Interventions
To provide Hypoglycemia Symptom Detection Training intervention.
Group IV: Education PlusExperimental Treatment2 Interventions
To provide Education Plus intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Basic Education
2002
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,792 Total Patients Enrolled
46 Trials studying Hypoglycemia
21,141 Patients Enrolled for Hypoglycemia
University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,432,985 Total Patients Enrolled
1 Trials studying Hypoglycemia
105 Patients Enrolled for Hypoglycemia
Yu Kuei Alex Lin, MDPrincipal InvestigatorUniversity of Michigan

Media Library

Education Plus Clinical Trial Eligibility Overview. Trial Name: NCT05916131 — N/A
Hypoglycemia Research Study Groups: Education Plus, Hypoglycemia Symptom Detection Training, Hypoglycemia Symptom Detection Training and Education Plus, Usual Care
Hypoglycemia Clinical Trial 2023: Education Plus Highlights & Side Effects. Trial Name: NCT05916131 — N/A
Education Plus 2023 Treatment Timeline for Medical Study. Trial Name: NCT05916131 — N/A
~3 spots leftby Jan 2025
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