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

University of Michigan40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Hypoglycemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: Approximately 4.5 months

Secondary Outcomes

Number of Potential Candidates Contacted During the Entire Recruitment Period

This number includes all potential candidates for enrollment contacted during the entire recruitment period, regardless of whether or not they ultimately enrolled in the study.

Time frame: Approximately 1 year (recruitment period)

Percentage of Contacted Potential Candidates Being Eligible

Percentage of contacted potential candidates who were eligibility-assessed and determined to be eligible for the study.

Time frame: Approximately 1 year (recruitment period)

Rate of Participant Retention at 12 Weeks

Number of participants who completed 12 weeks of the intervention

Time frame: 12 weeks

Rate of Participant Retention at 26 Weeks

Number of participants who completed 26-week follow-up visit

Time frame: 6 months

Rate of Participant Retention at 52 Weeks

Number of participants who completed 52-week follow-up visit

Time frame: 1 year

Participants With Continuous Glucose Monitoring (CGM) Data Collected at 12 Weeks

Percentage of participants whose CGM data was successfully collected at 12 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

Time frame: 12 weeks

Participants With Continuous Glucose Monitoring (CGM) Data Collected at 26 Weeks

Percentage of participants whose CGM data was successfully collected at 26 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

Time frame: 6 months

Participants With Continuous Glucose Monitoring (CGM) Data Collected at 52 Weeks

Percentage of participants whose CGM data was successfully collected at 52 weeks. Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

Time frame: 1 year

Participants Reporting Reading Message Content at the End of the Intervention

Assessed with a question adapted from mSustain questionnaire: "When you receive a HypoPals message, how much of it do you read?" Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

Time frame: 12 weeks

Participants Finding Message Content Helpful (Positive) at the End of the Intervention

Assessed with a study-purposed question: "Overall, HypoPals was helpful for me". Because percent is auto-calculated and displayed by ClinicalTrials.gov, the title has been simplified to reflect reporting number of participants for additional transparency.

Time frame: 12 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes