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Mobile Health Program for Low Blood Sugar Management
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had type 1 diabetes for at least 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of participants recruited to reach 20 participants that complete the intervention
Secondary outcome measures
Number of patients contacted during the entire recruitment period
Percentage of contacted patients being eligible and consented
Percentage of participants finding message content helpful (positive) at the end of the intervention
+7 moreTrial 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
2,359 Previous Clinical Trials
4,314,552 Total Patients Enrolled
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,098 Total Patients Enrolled
Yu Kuei Alex Lin, MDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow the study's rules, share my glucose data, get texts, and fill out questionnaires.I have untreated adrenal or thyroid issues.You have had very low blood sugar episodes while using CGMs or spend a lot of time with low blood sugar levels.You have a cellphone that can share data to Dexcom Clarity and receive text messages.You are currently taking part in a study related to diabetes or low blood sugar treatments.I have been using a continuous glucose monitor for at least 1 year.You have a mental disorder or cognitive dysfunction that is not being controlled with treatment.I have had type 1 diabetes for at least 5 years.You have been using a Dexcom continuous glucose monitor for at least 70% of the time according to your recent reports.You have attended a diabetes education program before.
Research Study Groups:
This trial has the following groups:- Group 1: Education Plus
- Group 2: Hypoglycemia Symptom Detection Training
- Group 3: Hypoglycemia Symptom Detection Training and Education Plus
- Group 4: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to enroll in this research study?
"The study seeks 40 volunteers with low blood sugar levels and aged between 18 to 70."
Answered by AI
Is the participant criteria for this study limited to adults 18 years of age and older?
"According to the set prerequisites of this trial, only individuals aged 18-70 can be admitted as participants."
Answered by AI
Is it still possible to enroll in this experiment?
"As per the information found on clinicaltrials.gov, this experiment is no longer looking for participants - its initial posting was July 1st 2023 and it was last updated June 14th of that same year. Despite not actively recruiting patients at present, there are 436 other studies currently searching for trial candidates."
Answered by AI
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