Hypoglycemia, Type 1 Diabetes
Conditions
Keywords
hypoglycemia, mobile health technology, text messaging
Brief 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. 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).
Interventions
BEHAVIORALBasic Education
2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
BEHAVIORALHypoglycemia Symptom Detection Training
10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.
BEHAVIORALEducation Plus
10-week text message intervention for helping people consider how they think of hypoglycemia.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention | Approximately 4.5 months | This number will include participants that were enrolled and received part or all of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Contacted Potential Candidates Being Eligible | Approximately 1 year (recruitment period) | Percentage of contacted potential candidates who were eligibility-assessed and determined to be eligible for the study. |
| Rate of Participant Retention at 12 Weeks | 12 weeks | Number of participants who completed 12 weeks of the intervention |
| Rate of Participant Retention at 26 Weeks | 6 months | Number of participants who completed 26-week follow-up visit |
| Rate of Participant Retention at 52 Weeks | 1 year | Number of participants who completed 52-week follow-up visit |
| Number of Potential Candidates Contacted During the Entire Recruitment Period | Approximately 1 year (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. |
| Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks | 6 months | 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. |
| Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks | 1 year | 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. |
| Participants Reporting Reading Message Content at the End of the Intervention | 12 weeks | 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. |
| Participants Finding Message Content Helpful (Positive) at the End of the Intervention | 12 weeks | 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. |
| Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypoglycemia Symptom Detection Training To provide Hypoglycemia Symptom Detection Training intervention. | 9 |
| Education Plus To provide Education Plus intervention. | 10 |
| Hypoglycemia Symptom Detection Training and Education Plus To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. | 11 |
| Usual Care Continuing usual care after basic education. | 10 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Hypoglycemia Symptom Detection Training | Total | Usual Care | Hypoglycemia Symptom Detection Training and Education Plus | Education Plus |
|---|---|---|---|---|---|
| Age, Continuous | 40 year | 40 year | 42 year | 37 year | 43 year |
| Continuous Glucose Monitoring (CGM) use duration 1-2 years | 0 Participants | 4 Participants | 1 Participants | 3 Participants | 0 Participants |
| Continuous Glucose Monitoring (CGM) use duration 3-6 years | 6 Participants | 23 Participants | 8 Participants | 4 Participants | 5 Participants |
| Continuous Glucose Monitoring (CGM) use duration More than 6 years | 3 Participants | 13 Participants | 1 Participants | 4 Participants | 5 Participants |
| Diabetes duration | 13 years | 21 years | 24 years | 24 years | 16 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 35 Participants | 9 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1C | 6.2 percent | 6.4 percent | 6.4 percent | 6.4 percent | 6.5 percent |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 33 Participants | 8 Participants | 10 Participants | 9 Participants |
| Region of Enrollment United States | 9 Participants | 40 Participants | 10 Participants | 11 Participants | 10 Participants |
| Sex/Gender, Customized Men | 5 Participants | 20 Participants | 3 Participants | 5 Participants | 7 Participants |
| Sex/Gender, Customized Prefer Not to Answer | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Women | 4 Participants | 19 Participants | 6 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 1 / 9 | 1 / 10 | 1 / 11 | 3 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 | 1 / 11 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Approximately 4.5 months
Population: Because this measure pertains to the study as a whole, regardless of arm, number of participants is not reported by arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention | 20 Participants |
Secondary
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.
Time frame: Approximately 1 year (recruitment period)
Population: Total number of potential candidates who were contacted for potential enrollment, whether they were ultimately eligibility assessed/enrolled or not. Because this measure pertains to the study as a whole, regardless of arm, number of participants is not reported by arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Number of Potential Candidates Contacted During the Entire Recruitment Period | 227 Potential candidates |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Recruited Who Completed the Intervention | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'definitively' and 'somewhat' | 1 Participants |
| Participants Recruited Who Completed the Intervention | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Definitively | 4 Participants |
| Participants Recruited Who Completed the Intervention | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Somewhat | 3 Participants |
| Participants Recruited Who Completed the Intervention | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Not at all | 0 Participants |
| Participants Recruited Who Completed the Intervention | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'somewhat' and 'not at all' | 1 Participants |
| Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Somewhat | 1 Participants |
| Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Definitively | 3 Participants |
| Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'definitively' and 'somewhat' | 4 Participants |
| Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'somewhat' and 'not at all' | 1 Participants |
| Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Not at all | 1 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Somewhat | 3 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Definitively | 1 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Not at all | 1 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'somewhat' and 'not at all' | 0 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'definitively' and 'somewhat' | 6 Participants |
| Usual Care | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'somewhat' and 'not at all' | 0 Participants |
| Usual Care | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Somewhat | 4 Participants |
| Usual Care | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Definitively | 3 Participants |
| Usual Care | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Not at all | 1 Participants |
| Usual Care | Participants Finding Message Content Helpful (Positive) at the End of the Intervention | Between 'definitively' and 'somewhat' | 2 Participants |
Secondary
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.
Time frame: 12 weeks
Population: The usual care group did not receive any intervention messages after completing the initial 2-week basic education.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Recruited Who Completed the Intervention | Participants Reporting Reading Message Content at the End of the Intervention | About a quarter of the message | 0 Participants |
| Participants Recruited Who Completed the Intervention | Participants Reporting Reading Message Content at the End of the Intervention | About half of the message | 0 Participants |
| Participants Recruited Who Completed the Intervention | Participants Reporting Reading Message Content at the End of the Intervention | The whole message | 6 Participants |
| Participants Recruited Who Completed the Intervention | Participants Reporting Reading Message Content at the End of the Intervention | About three-quarters of the message | 2 Participants |
| Participants Recruited Who Completed the Intervention | Participants Reporting Reading Message Content at the End of the Intervention | Not at all | 1 Participants |
| Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | About half of the message | 0 Participants |
| Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | The whole message | 9 Participants |
| Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | About three-quarters of the message | 0 Participants |
| Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | About a quarter of the message | 1 Participants |
| Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | Not at all | 0 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | Not at all | 0 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | About a quarter of the message | 1 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | The whole message | 9 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | About half of the message | 0 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants Reporting Reading Message Content at the End of the Intervention | About three-quarters of the message | 1 Participants |
Secondary
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.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks | 9 Participants |
| Education Plus | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks | 10 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks | 11 Participants |
| Usual Care | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks | 10 Participants |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks | 9 Participants |
| Education Plus | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks | 10 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks | 11 Participants |
| Usual Care | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks | 10 Participants |
Secondary
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks | 9 Participants |
| Education Plus | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks | 10 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks | 11 Participants |
| Usual Care | Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks | 9 Participants |
Secondary
Percentage of Contacted Potential Candidates Being Eligible
Percentage of contacted potential candidates who were eligibility-assessed and determined to be eligible for the study.
Time frame: Approximately 1 year (recruitment period)
Population: All potential candidates who were contacted and completed the eligibility assessment for enrollment, regardless of whether or not they ultimately enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Percentage of Contacted Potential Candidates Being Eligible | 35.1 Percent of assessed potential candidates |
Secondary
Rate of Participant Retention at 12 Weeks
Number of participants who completed 12 weeks of the intervention
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Rate of Participant Retention at 12 Weeks | 9 Participants |
| Education Plus | Rate of Participant Retention at 12 Weeks | 10 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Rate of Participant Retention at 12 Weeks | 11 Participants |
| Usual Care | Rate of Participant Retention at 12 Weeks | 10 Participants |
Secondary
Rate of Participant Retention at 26 Weeks
Number of participants who completed 26-week follow-up visit
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Rate of Participant Retention at 26 Weeks | 9 Participants |
| Education Plus | Rate of Participant Retention at 26 Weeks | 10 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Rate of Participant Retention at 26 Weeks | 10 Participants |
| Usual Care | Rate of Participant Retention at 26 Weeks | 10 Participants |
Secondary
Rate of Participant Retention at 52 Weeks
Number of participants who completed 52-week follow-up visit
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Recruited Who Completed the Intervention | Rate of Participant Retention at 52 Weeks | 9 Participants |
| Education Plus | Rate of Participant Retention at 52 Weeks | 10 Participants |
| Hypoglycemia Symptom Detection Training and Education Plus | Rate of Participant Retention at 52 Weeks | 10 Participants |
| Usual Care | Rate of Participant Retention at 52 Weeks | 10 Participants |