Trial Outcomes & Findings for Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management. (NCT NCT05916131)
NCT ID: NCT05916131
Last Updated: 2025-06-18
Results Overview
This number will include participants that were enrolled and received part or all of the intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Approximately 4.5 months
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
Usual Care
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
11
|
10
|
|
Overall Study
Completed 12 Week Intervention
|
9
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
Usual Care
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
Baseline characteristics by cohort
| Measure |
Hypoglycemia Symptom Detection Training
n=9 Participants
To provide Hypoglycemia Symptom Detection Training intervention.
|
Education Plus
n=10 Participants
To provide Education Plus intervention.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40 year
n=5 Participants
|
43 year
n=7 Participants
|
37 year
n=5 Participants
|
42 year
n=4 Participants
|
40 year
n=21 Participants
|
|
Sex/Gender, Customized
Men
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Women
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Prefer Not to Answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Diabetes duration
|
13 years
n=5 Participants
|
16 years
n=7 Participants
|
24 years
n=5 Participants
|
24 years
n=4 Participants
|
21 years
n=21 Participants
|
|
Hemoglobin A1C
|
6.2 percent
n=5 Participants
|
6.5 percent
n=7 Participants
|
6.4 percent
n=5 Participants
|
6.4 percent
n=4 Participants
|
6.4 percent
n=21 Participants
|
|
Continuous Glucose Monitoring (CGM) use duration
1-2 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Continuous Glucose Monitoring (CGM) use duration
3-6 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Continuous Glucose Monitoring (CGM) use duration
More than 6 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Approximately 4.5 monthsPopulation: Because this measure pertains to the study as a whole, regardless of arm, number of participants is not reported by arm.
This number will include participants that were enrolled and received part or all of the intervention.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=20 Participants
All participants recruited who complete the intervention
|
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.
|
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.
|
Usual Care
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention
|
20 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=227 Participants
All participants recruited who complete the intervention
|
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.
|
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.
|
Usual Care
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Number of Potential Candidates Contacted During the Entire Recruitment Period
|
227 Potential candidates
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Percentage of contacted potential candidates who were eligibility-assessed and determined to be eligible for the study.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=114 Participants
All participants recruited who complete the intervention
|
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.
|
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.
|
Usual Care
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Percentage of Contacted Potential Candidates Being Eligible
|
35.1 Percent of assessed potential candidates
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeksNumber of participants who completed 12 weeks of the intervention
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Rate of Participant Retention at 12 Weeks
|
9 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants who completed 26-week follow-up visit
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Rate of Participant Retention at 26 Weeks
|
9 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants who completed 52-week follow-up visit
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Rate of Participant Retention at 52 Weeks
|
9 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPercentage 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.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks
|
9 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage 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.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks
|
9 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage 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.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks
|
9 Participants
|
10 Participants
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The usual care group did not receive any intervention messages after completing the initial 2-week basic education.
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.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Participants Reporting Reading Message Content at the End of the Intervention
The whole message
|
6 Participants
|
9 Participants
|
9 Participants
|
—
|
|
Participants Reporting Reading Message Content at the End of the Intervention
About three-quarters of the message
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Participants Reporting Reading Message Content at the End of the Intervention
About half of the message
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Participants Reporting Reading Message Content at the End of the Intervention
About a quarter of the message
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Participants Reporting Reading Message Content at the End of the Intervention
Not at all
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksAssessed 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.
Outcome measures
| Measure |
Participants Recruited Who Completed the Intervention
n=9 Participants
All participants recruited who complete the intervention
|
Education Plus
n=10 Participants
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 Participants
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.
|
Usual Care
n=10 Participants
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Participants Finding Message Content Helpful (Positive) at the End of the Intervention
Between 'somewhat' and 'not at all'
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Participants Finding Message Content Helpful (Positive) at the End of the Intervention
Definitively
|
4 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Participants Finding Message Content Helpful (Positive) at the End of the Intervention
Between 'definitively' and 'somewhat'
|
1 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Participants Finding Message Content Helpful (Positive) at the End of the Intervention
Somewhat
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Participants Finding Message Content Helpful (Positive) at the End of the Intervention
Not at all
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Hypoglycemia Symptom Detection Training
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Education Plus
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Hypoglycemia Symptom Detection Training and Education Plus
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hypoglycemia Symptom Detection Training
n=9 participants at risk
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.
|
Education Plus
n=10 participants at risk
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 participants at risk
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.
|
Usual Care
n=10 participants at risk
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Endocrine disorders
Hospitalization due to Hypoglycemia
|
0.00%
0/9 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
9.1%
1/11 • Number of events 1 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
Other adverse events
| Measure |
Hypoglycemia Symptom Detection Training
n=9 participants at risk
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.
|
Education Plus
n=10 participants at risk
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.
|
Hypoglycemia Symptom Detection Training and Education Plus
n=11 participants at risk
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.
|
Usual Care
n=10 participants at risk
Continuing usual care after basic education.
Basic Education: 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
|
|---|---|---|---|---|
|
Endocrine disorders
Hyperglycemia with/without confirmed ketosis
|
0.00%
0/9 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
9.1%
1/11 • Number of events 1 • 52 weeks
|
10.0%
1/10 • Number of events 1 • 52 weeks
|
|
Endocrine disorders
Hypoglycemia requiring Emergency Medical Services
|
0.00%
0/9 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
9.1%
1/11 • 52 weeks
|
10.0%
1/10 • Number of events 1 • 52 weeks
|
|
Immune system disorders
Food allergy
|
11.1%
1/9 • Number of events 1 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
0.00%
0/11 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
0.00%
0/11 • 52 weeks
|
10.0%
1/10 • Number of events 1 • 52 weeks
|
|
Injury, poisoning and procedural complications
Fibrosis
|
0.00%
0/9 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
0.00%
0/11 • 52 weeks
|
10.0%
1/10 • Number of events 1 • 52 weeks
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/9 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
0.00%
0/11 • 52 weeks
|
10.0%
1/10 • Number of events 1 • 52 weeks
|
|
Reproductive system and breast disorders
Papanicolaou smear abnormal
|
0.00%
0/9 • 52 weeks
|
10.0%
1/10 • 52 weeks
|
0.00%
0/11 • 52 weeks
|
0.00%
0/10 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place