Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
Type 1 Diabetes, Hypoglycemia
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring hypoglycemia, mobile health technology, text messaging
Eligibility Criteria
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)
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Other
Hypoglycemia Symptom Detection Training
Education Plus
Hypoglycemia Symptom Detection Training and Education Plus
Usual Care
To provide Hypoglycemia Symptom Detection Training intervention.
To provide Education Plus intervention.
To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.
Continuing usual care after basic education.