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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Hypoglycemia; Type 1 Diabetes
• Intervention / Treatment: Behavioral: Basic Education; Behavioral: Hypoglycemia Symptom Detection Training; Behavioral: Education Plus

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Hepworth; Phone Number: 208-670-3892; Email: hepworem@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Emily Hepworth; Phone Number: 208-670-3892; Email: hepworem@med.umich.edu
      • Principal Investigator: Yu Kuei Alex Lin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Yu Kuei Alex Lin, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: hypoglycemia; text messaging; mobile health technology
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: HUM00228484; 1K23DK129724-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No