Clinical trial NCT05916131: Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
Official title: Pilot and Feasibility Trial of HypoPals, a Mobile Health Intervention for Improving Hypoglycemia Self-management in Type 1 Diabetes Adults Using Advanced Diabetes Technologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
Keywords: hypoglycemia
mobile health technology
text messaging
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SUPPORTIVE_CARE

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).


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)

Primary outcomes:
measure: The Number of Participants Recruited to Reach 20 Participants That Complete the Intervention
timeFrame: Approximately 4.5 months
Secondary outcomes:
measure: Number of Potential Candidates Contacted During the Entire Recruitment Period
timeFrame: Approximately 1 year (recruitment period)
measure: Percentage of Contacted Potential Candidates Being Eligible
timeFrame: Approximately 1 year (recruitment period)
measure: Rate of Participant Retention at 12 Weeks
timeFrame: 12 weeks
measure: Rate of Participant Retention at 26 Weeks
timeFrame: 6 months
measure: Rate of Participant Retention at 52 Weeks
timeFrame: 1 year
measure: Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks
timeFrame: 12 weeks
measure: Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks
timeFrame: 6 months
measure: Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks
timeFrame: 1 year
measure: Participants Reporting Reading Message Content at the End of the Intervention
timeFrame: 12 weeks
measure: Participants Finding Message Content Helpful (Positive) at the End of the Intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yu Kuei Alex Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: