Type 1 DiabetesNCT05916131
Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
A study testing Basic Education, Hypoglycemia Symptom Detection Training and Education Plus in people with Type 1 Diabetes and Hypoglycemia, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Basic Education, Hypoglycemia Symptom Detection Training and Education Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 12 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Self-reported diagnosis of type 1 diabetes for at least 5 years
- Previous attendance of structured diabetes education program
- Using CGM greater or equal to (≥1) year
- Ongoing Dexcom CGM use time ≥70% based on CGM report at screening
- Have had experienced ≥1 episode of severe hypoglycemia in the past year while using CGMs or spending ≥1% of time in level 2 hypoglycemia at the time of pre-screening
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- Using cellphone with functionality for sharing real-time data to Dexcom Clarity and receiving text messages
- Be able to communicate in English (spoken and written)
- Willing to comply with all study procedures including sharing CGM glucose information, receiving and reading intervention text messages, and completing study questionnaires
Who cannot join
- Active participation in clinical trials on diabetes/hypoglycemia interventions
- Pregnancy or planning for pregnancy within a year
- Untreated adrenal insufficiency or hypothyroidism
- Uncontrolled mental disorder or chronic cognitive dysfunctions (include but not limited to uncontrolled schizophrenia, depression and bipolar disorders; learning disability; active alcohol and substance dependence; dementia or cognitive impairment independent of hypoglycemia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot and Feasibility Trial of HypoPals, a Mobile Health Intervention for Improving Hypoglycemia Self-management in Type 1 Diabetes Adults Using Advanced Diabetes Technologies
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).
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Basic Education, Hypoglycemia Symptom Detection Training, Education Plus
- Keywords
- hypoglycemia, mobile health technology, text messaging
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic EducationBehavioural
2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
Hypoglycemia Symptom Detection TrainingBehavioural
10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.
Education PlusBehavioural
10-week text message intervention for helping people consider how they think of hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Hypoglycemia Symptom Detection Training | Experimental | To provide Hypoglycemia Symptom Detection Training intervention. Receives: Behavioral: Basic Education; Behavioral: Hypoglycemia Symptom Detection Training |
| Education Plus | Experimental | To provide Education Plus intervention. Receives: Behavioral: Basic Education; Behavioral: Education Plus |
| Hypoglycemia Symptom Detection Training and Education Plus | Experimental | To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. Receives: Behavioral: Basic Education; Behavioral: Hypoglycemia Symptom Detection Training; Behavioral: Education Plus |
| Usual Care | Other | Continuing usual care after basic education. Receives: Behavioral: Basic Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention
This number will include participants that were enrolled and received part or all of the intervention.
Measured: Approximately 4.5 months
Secondary outcomes (10)
Number of Potential Candidates Contacted During the Entire Recruitment Period
This number includes all potential candidates for enrollment contacted during the entire recruitment period, regardless of whether or not they ultimately enrolled in the study.
Measured: Approximately 1 year (recruitment period)
Percentage of Contacted Potential Candidates Being Eligible
Percentage of contacted potential candidates who were eligibility-assessed and determined to be eligible for the study.
Measured: Approximately 1 year (recruitment period)
Rate of Participant Retention at 12 Weeks
Number of participants who completed 12 weeks of the intervention
Measured: 12 weeks
Rate of Participant Retention at 26 Weeks
Number of participants who completed 26-week follow-up visit
Measured: 6 months
Rate of Participant Retention at 52 Weeks
Number of participants who completed 52-week follow-up visit
Measured: 1 year
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks
Percentage of participants whose CGM data was successfully collected at 12 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.
Measured: 12 weeks
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks
Percentage of participants whose CGM data was successfully collected at 26 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.
Measured: 6 months
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks
Percentage of participants whose CGM data was successfully collected at 52 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.
Measured: 1 year
Participants Reporting Reading Message Content at the End of the Intervention
Assessed with a question adapted from mSustain questionnaire: "When you receive a HypoPals message, how much of it do you read?" Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.
Measured: 12 weeks
Participants Finding Message Content Helpful (Positive) at the End of the Intervention
Assessed with a study-purposed question: "Overall, HypoPals was helpful for me". Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start19 Sep 2023
- Primary completion2 Feb 2024
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Adaptive randomization with minimization method will be conducted to ensure equal number of participants (n=10) will be randomized into the same number of the 4 experimental conditions (i.e., in 1:1:1:1 ratio). The randomization will be stratified based on whether the participant have severe hypoglycemia within the year or spending greater or equal to 1 percent of time in level 2 hypoglycemia on CGM, and the status of closed-loop pump use.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Kuei Alex Lin, University of Michigan
- Investigators
- Yu Kuei Alex Lin, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916131
- Sponsor's protocol ID
- HUM00228484
- Other IDs
- 1K23DK129724-01
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2023
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Trial of HypoPals, a Mobile Health Intervention for Improving Hypoglycemia Self-management in Type 1 Diabetes Adults Using Advanced Diabetes Technologies
- ClinicalTrials.gov ID
- NCT05916131
- Acronym / sponsor ID
- HUM00228484
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- hypoglycemia, mobile health technology, text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Adaptive randomization with minimization method will be conducted to ensure equal number of participants (n=10) will be randomized into the same number of the 4 experimental conditions (i.e., in 1:1:1:1 ratio). The randomization will be stratified based on whether the participant have severe hypoglycemia within the year or spending greater or equal to 1 percent of time in level 2 hypoglycemia on CGM, and the status of closed-loop pump use.
| Arm | Type | Receives |
|---|---|---|
| Hypoglycemia Symptom Detection Training | Experimental | Behavioral: Basic Education, Behavioral: Hypoglycemia Symptom Detection TrainingTo provide Hypoglycemia Symptom Detection Training intervention. |
| Education Plus | Experimental | Behavioral: Basic Education, Behavioral: Education PlusTo provide Education Plus intervention. |
| Hypoglycemia Symptom Detection Training and Education Plus | Experimental | Behavioral: Basic Education, Behavioral: Hypoglycemia Symptom Detection Training, Behavioral: Education PlusTo provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. |
| Usual Care | Other | Behavioral: Basic EducationContinuing usual care after basic education. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed and dated informed consent form
- Self-reported diagnosis of type 1 diabetes for at least 5 years
- Previous attendance of structured diabetes education program
- Using CGM greater or equal to (≥1) year
- Ongoing Dexcom CGM use time ≥70% based on CGM report at screening
Key exclusion criteria (4 listed)
- Active participation in clinical trials on diabetes/hypoglycemia interventions
- Pregnancy or planning for pregnancy within a year
- Untreated adrenal insufficiency or hypothyroidism
- Uncontrolled mental disorder or chronic cognitive dysfunctions (include but not limited to uncontrolled schizophrenia, depression and bipolar disorders; learning disability; active alcohol and substance dependence; dementia or cognitive impairment independent of hypoglycemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Education2-week text message intervention for providing knowledge about hypoglycemia management and prevention. | Behavioural | Education Plus, Hypoglycemia Symptom Detection Training, Hypoglycemia Symptom Detection Training and Education Plus, Usual Care |
| Hypoglycemia Symptom Detection Training10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms. | Behavioural | Hypoglycemia Symptom Detection Training, Hypoglycemia Symptom Detection Training and Education Plus |
| Education Plus10-week text message intervention for helping people consider how they think of hypoglycemia. | Behavioural | Education Plus, Hypoglycemia Symptom Detection Training and Education Plus |
Primary outcome
The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention
Time frame: Approximately 4.5 months
This number will include participants that were enrolled and received part or all of the intervention.
10 secondary outcomes
Number of Potential Candidates Contacted During the Entire Recruitment Period
Time frame: Approximately 1 year (recruitment period)
Percentage of Contacted Potential Candidates Being Eligible
Time frame: Approximately 1 year (recruitment period)
Rate of Participant Retention at 12 Weeks
Time frame: 12 weeks
Rate of Participant Retention at 26 Weeks
Time frame: 6 months
Rate of Participant Retention at 52 Weeks
Time frame: 1 year
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks
Time frame: 12 weeks
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks
Time frame: 6 months
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks
Time frame: 1 year
Participants Reporting Reading Message Content at the End of the Intervention
Time frame: 12 weeks
Participants Finding Message Content Helpful (Positive) at the End of the Intervention
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Kuei Alex Lin, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Education, Hypoglycemia Symptom Detection Training and Education Plus in people with Type 1 Diabetes and Hypoglycemia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention (time frame: Approximately 4.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.