Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.

Study Overview
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Brief Summary
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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).

Official Title
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Pilot and Feasibility Trial of HypoPals, a Mobile Health Intervention for Improving Hypoglycemia Self-management in Type 1 Diabetes Adults Using Advanced Diabetes Technologies

Conditions
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Type 1 Diabetes, Hypoglycemia

Intervention / Treatment
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* Behavioral: Basic Education
* Behavioral: Hypoglycemia Symptom Detection Training
* Behavioral: Education Plus


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypoglycemia Symptom Detection Training<br>To provide Hypoglycemia Symptom Detection Training intervention. | Behavioral: Basic Education<br>* 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.<br>Behavioral: Hypoglycemia Symptom Detection Training<br>* 10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.<br>|
| Experimental: Education Plus<br>To provide Education Plus intervention. | Behavioral: Basic Education<br>* 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.<br>Behavioral: Education Plus<br>* 10-week text message intervention for helping people consider how they think of hypoglycemia.<br>|
| Experimental: Hypoglycemia Symptom Detection Training and Education Plus<br>To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously. | Behavioral: Basic Education<br>* 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.<br>Behavioral: Hypoglycemia Symptom Detection Training<br>* 10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.<br>Behavioral: Education Plus<br>* 10-week text message intervention for helping people consider how they think of hypoglycemia.<br>|
| Other: Usual Care<br>Continuing usual care after basic education. | Behavioral: Basic Education<br>* 2-week text message intervention for providing knowledge about hypoglycemia management and prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 1 year (recruitment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients contacted during the entire recruitment period |  | Approximately 1 year (recruitment period) | 
| Percentage of contacted patients being eligible and consented |  | Approximately 1 year (recruitment period) | 
| Rate of participant retention at 12 weeks |  | 12 weeks | 
| Rate of participant retention at 26 weeks |  | 6 months | 
| Rate of participant retention at 52 weeks |  | 1 year | 
| Percentage of participants with continuous glucose monitoring (CGM) data collected at 12 weeks |  | 12 weeks | 
| Percentage of participants with continuous glucose monitoring (CGM) data collected at 26 weeks |  | 6 months | 
| Percentage of participants with continuous glucose monitoring (CGM) data collected at 52 weeks |  | 1 year | 
| Percentage of participants reporting reading message content at the end of the intervention |  | 12 weeks | 
| Percentage of participants finding message content helpful (positive) at the end of the intervention | The outcome will be determined as positive/negative and the study team will report the percent of participants reporting positive outcome. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypoglycemia, mobile health technology, text messaging