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

University of Michigan

Status: Completed

Conditions: Hypoglycemia; Type 1 Diabetes

Treatments: Behavioral: Education Plus; Behavioral: Basic Education; Behavioral: Hypoglycemia Symptom Detection Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05916131

HUM00228484

1K23DK129724-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Hypoglycemia Symptom Detection Training

Experimental group

Description:

To provide Hypoglycemia Symptom Detection Training intervention.

Treatment:

Behavioral: Hypoglycemia Symptom Detection Training

Behavioral: Basic Education

Education Plus

Experimental group

Description:

To provide Education Plus intervention.

Treatment:

Behavioral: Basic Education

Behavioral: Education Plus

Hypoglycemia Symptom Detection Training and Education Plus

Experimental group

Description:

To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.

Treatment:

Behavioral: Hypoglycemia Symptom Detection Training

Behavioral: Basic Education

Behavioral: Education Plus

Usual Care

Other group

Description:

Continuing usual care after basic education.

Treatment:

Behavioral: Basic Education