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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK129724-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglycemia Symptom Detection Training | Experimental | To provide Hypoglycemia Symptom Detection Training intervention. |
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| Education Plus | Experimental | To provide Education Plus intervention. |
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| Hypoglycemia Symptom Detection Training and Education Plus | Experimental | To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. |
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| Usual Care | Other | Continuing usual care after basic education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basic Education | Behavioral | 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 4.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 1 year (recruitment period) |
| Percentage of Contacted Potential Candidates Being Eligible |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Kuei Alex Lin, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypoglycemia Symptom Detection Training | To provide Hypoglycemia Symptom Detection Training intervention. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. Hypoglycemia Symptom Detection Training: 10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms. |
| FG001 | Education Plus | To provide Education Plus intervention. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. Education Plus: 10-week text message intervention for helping people consider how they think of hypoglycemia. |
| FG002 | Hypoglycemia Symptom Detection Training and Education Plus | To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. Hypoglycemia Symptom Detection Training: 10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms. Education Plus: 10-week text message intervention for helping people consider how they think of hypoglycemia. |
| FG003 | Usual Care | Continuing usual care after basic education. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypoglycemia Symptom Detection Training | To provide Hypoglycemia Symptom Detection Training intervention. |
| BG001 | Education Plus | To provide Education Plus intervention. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Because this measure pertains to the study as a whole, regardless of arm, number of participants is not reported by arm. | Posted | Count of Participants | Participants | No | Approximately 4.5 months |
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|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypoglycemia Symptom Detection Training | To provide Hypoglycemia Symptom Detection Training intervention. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. Hypoglycemia Symptom Detection Training: 10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to Hypoglycemia | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia with/without confirmed ketosis | Endocrine disorders | Systematic Assessment |
This is a pilot feasibility trial focused on the feasibility of running similar studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yu Kuei Lin, MD | University of Michigan | 734-232-1573 | yuklin@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2023 | May 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 21, 2023 | May 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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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.
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| Hypoglycemia Symptom Detection Training | Behavioral | 10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms. |
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| Education Plus | Behavioral | 10-week text message intervention for helping people consider how they think of hypoglycemia. |
|
Percentage of contacted potential candidates who were eligibility-assessed and determined to be eligible for the study. |
| Approximately 1 year (recruitment period) |
| Rate of Participant Retention at 12 Weeks | Number of participants who completed 12 weeks of the intervention | 12 weeks |
| Rate of Participant Retention at 26 Weeks | Number of participants who completed 26-week follow-up visit | 6 months |
| Rate of Participant Retention at 52 Weeks | Number of participants who completed 52-week follow-up visit | 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. | 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. | 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. | 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. | 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. | 12 weeks |
| BG002 | Hypoglycemia Symptom Detection Training and Education Plus | To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. |
| BG003 | Usual Care | Continuing usual care after basic education. |
| BG004 | Total | Total of all reporting groups |
| year |
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| Sex/Gender, Customized | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Diabetes duration | Median | Inter-Quartile Range | years |
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| Hemoglobin A1C | Median | Inter-Quartile Range | percent |
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| Continuous Glucose Monitoring (CGM) use duration | Count of Participants | Participants | No |
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| 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. | 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. | Posted | Number | Potential candidates | Approximately 1 year (recruitment period) |
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|
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| 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. | All potential candidates who were contacted and completed the eligibility assessment for enrollment, regardless of whether or not they ultimately enrolled in the study. | Posted | Number | Percent of assessed potential candidates | Approximately 1 year (recruitment period) |
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|
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| Secondary | Rate of Participant Retention at 12 Weeks | Number of participants who completed 12 weeks of the intervention | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Rate of Participant Retention at 26 Weeks | Number of participants who completed 26-week follow-up visit | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Rate of Participant Retention at 52 Weeks | Number of participants who completed 52-week follow-up visit | Posted | Count of Participants | Participants | 1 year |
|
|
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| 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
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| 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. | Posted | Count of Participants | Participants | 1 year |
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|
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| 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. | The usual care group did not receive any intervention messages after completing the initial 2-week basic education. | Posted | Count of Participants | Participants | 12 weeks |
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| 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. | Posted | Count of Participants | Participants | 12 weeks |
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| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | Education Plus | To provide Education Plus intervention. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. Education Plus: 10-week text message intervention for helping people consider how they think of hypoglycemia. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Hypoglycemia Symptom Detection Training and Education Plus | To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. Hypoglycemia Symptom Detection Training: 10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms. Education Plus: 10-week text message intervention for helping people consider how they think of hypoglycemia. | 0 | 11 | 1 | 11 | 1 | 11 |
| EG003 | Usual Care | Continuing usual care after basic education. Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention. | 0 | 10 | 0 | 10 | 3 | 10 |
| Hypoglycemia requiring Emergency Medical Services | Endocrine disorders | Systematic Assessment |
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| Food allergy | Immune system disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Fibrosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Kidney stone | Renal and urinary disorders | Systematic Assessment |
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| Papanicolaou smear abnormal | Reproductive system and breast disorders | Systematic Assessment |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| About half of the message |
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| About a quarter of the message |
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| Not at all |
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| Between 'definitively' and 'somewhat' |
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| Somewhat |
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| Between 'somewhat' and 'not at all' |
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| Not at all |
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