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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916131
• Other study ID #: HUM00228484
• Secondary ID: 1K23DK129724-01
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Emily Hepworth
• Phone: 208-670-3892
• Email: hepworem[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Approximately 1 year (recruitment period)
Secondary	Number of patients contacted during the entire recruitment period		Approximately 1 year (recruitment period)
Secondary	Percentage of contacted patients being eligible and consented		Approximately 1 year (recruitment period)
Secondary	Rate of participant retention at 12 weeks		12 weeks
Secondary	Rate of participant retention at 26 weeks		6 months
Secondary	Rate of participant retention at 52 weeks		1 year
Secondary	Percentage of participants with continuous glucose monitoring (CGM) data collected at 12 weeks		12 weeks
Secondary	Percentage of participants with continuous glucose monitoring (CGM) data collected at 26 weeks		6 months
Secondary	Percentage of participants with continuous glucose monitoring (CGM) data collected at 52 weeks		1 year
Secondary	Percentage of participants reporting reading message content at the end of the intervention		12 weeks
Secondary	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