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

Primary Purpose

Type 1 Diabetes, Hypoglycemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Basic Education
Hypoglycemia Symptom Detection Training
Education Plus
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring hypoglycemia, mobile health technology, text messaging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Hypoglycemia Symptom Detection Training

Education Plus

Hypoglycemia Symptom Detection Training and Education Plus

Usual Care

Arm Description

To provide Hypoglycemia Symptom Detection Training intervention.

To provide Education Plus intervention.

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

Continuing usual care after basic education.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients contacted during the entire recruitment period
Percentage of contacted patients being eligible and consented
Rate of participant retention at 12 weeks
Rate of participant retention at 26 weeks
Rate of participant retention at 52 weeks
Percentage of participants with continuous glucose monitoring (CGM) data collected at 12 weeks
Percentage of participants with continuous glucose monitoring (CGM) data collected at 26 weeks
Percentage of participants with continuous glucose monitoring (CGM) data collected at 52 weeks
Percentage of participants reporting reading message content at the end of the intervention
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.

Full Information

First Posted
June 14, 2023
Last Updated
October 2, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05916131
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia
Keywords
hypoglycemia, mobile health technology, text messaging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoglycemia Symptom Detection Training
Arm Type
Experimental
Arm Description
To provide Hypoglycemia Symptom Detection Training intervention.
Arm Title
Education Plus
Arm Type
Experimental
Arm Description
To provide Education Plus intervention.
Arm Title
Hypoglycemia Symptom Detection Training and Education Plus
Arm Type
Experimental
Arm Description
To provide both Hypoglycemia Symptom Detection Training and Education Plus interventions simultaneously.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Continuing usual care after basic education.
Intervention Type
Behavioral
Intervention Name(s)
Basic Education
Intervention Description
2-week text message intervention for providing knowledge about hypoglycemia management and prevention.
Intervention Type
Behavioral
Intervention Name(s)
Hypoglycemia Symptom Detection Training
Intervention Description
10-week text message intervention for providing training on skills of detecting hypoglycemia symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Education Plus
Intervention Description
10-week text message intervention for helping people consider how they think of hypoglycemia.
Primary Outcome Measure Information:
Title
The number of participants recruited to reach 20 participants that complete the intervention
Description
This number will include participants that were enrolled and received part or all of the intervention.
Time Frame
Approximately 1 year (recruitment period)
Secondary Outcome Measure Information:
Title
Number of patients contacted during the entire recruitment period
Time Frame
Approximately 1 year (recruitment period)
Title
Percentage of contacted patients being eligible and consented
Time Frame
Approximately 1 year (recruitment period)
Title
Rate of participant retention at 12 weeks
Time Frame
12 weeks
Title
Rate of participant retention at 26 weeks
Time Frame
6 months
Title
Rate of participant retention at 52 weeks
Time Frame
1 year
Title
Percentage of participants with continuous glucose monitoring (CGM) data collected at 12 weeks
Time Frame
12 weeks
Title
Percentage of participants with continuous glucose monitoring (CGM) data collected at 26 weeks
Time Frame
6 months
Title
Percentage of participants with continuous glucose monitoring (CGM) data collected at 52 weeks
Time Frame
1 year
Title
Percentage of participants reporting reading message content at the end of the intervention
Time Frame
12 weeks
Title
Percentage of participants finding message content helpful (positive) at the end of the intervention
Description
The outcome will be determined as positive/negative and the study team will report the percent of participants reporting positive outcome.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Hepworth
Phone
208-670-3892
Email
hepworem@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Kuei Alex Lin, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Hepworth
Phone
208-670-3892
Email
hepworem@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Yu Kuei Alex Lin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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