Insulin Start Therapy Application With Resources and Training (I-START)

July 7, 2022 updated by: Linda Siminerio, University of Pittsburgh

Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy

The purpose of the I-START study is to evaluate an educational phone application (app) designed to support patients with type 2 diabetes (T2DM) by reinforcing the necessary skills needed for insulin administration as part of diabetes self-management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Despite advances in technology and delivery systems, patients with T2DM continue to be reluctant to begin and adhere to insulin therapy for a variety of reasons. Introducing insulin therapy is particularly problematic during a hospitalization or a brief routine outpatient visit given time and resource constraints. Teaching people to administer an insulin injection requires time and ongoing support. Therefore, this study aims to evaluate an educational phone application designed to support patients with T2DM by reinforcing skills and self-management behaviors needed for insulin administration. Patients with T2DM who are starting insulin or need updated instruction on insulin will be invited to participate in this study to examine the effect of the phone app on psychological barriers to insulin as well as patient and provider satisfaction with and usability of the phone app in both outpatient and hospital settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age
  • Able to read and follow study instructions in English (translations will not be provided)
  • T2DM requiring the use of prandial and/or long-acting insulin
  • Ability to self-administer insulin therapy
  • Willing to download the study app on their smartphone
  • Able and willing to provide a signed consent
  • Able and willing to follow all study procedures

Exclusion Criteria:

  • Pregnant (self-reported)
  • Participants from the same household participating concurrently
  • Use of a smartphone with iOS version 10.0 or lower
  • Use of a smartphone with Android OS 5.0 "Lollipop" or lower
  • Currently using a continuous subcutaneous insulin infusion device
  • Participants with major depression
  • Currently or planning to participate in a similar study that would affect the results of this study
  • Currently or planning to participate in a clinical study that involves taking a drug, supplement, or use of an investigational drug
  • Continued hospitalization or transfer to an assisted living facility
  • Any condition the PI or designee deems to pose a risk to the participant in the study (includes anything that may prevent full participation in the study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants assigned to the intervention group will receive insulin administration education according to standard procedures plus have access to the I-START app. Over the course of the study period, participants will be able to use I-START as much or as little as they prefer.
Behavioral: I-START
Designed as a supplementary educational tool for patients on insulin therapy, I-START includes an injection plan to reinforce the knowledge and behaviors that users have been taught by their health care provider. This is done through eight modules created for the benefit of new and experienced insulin users, and those using pens or vial/syringes. The modules address a variety of topics pertinent to insulin therapy, including overcoming psychosocial barriers, injection techniques and best practices, managing hypo- and hyperglycemic events, monitoring blood glucose and troubleshooting and problem solving. At the end of each module, users can self-evaluate their confidence in mastering the information presented. This gives them the ability to move forward into the next module, repeat material already presented and/or save features of the modules that they would like to revisit at another time.
Behavioral: Standard Insulin Administration Education
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
Active Comparator: Usual Care
Participants in the usual care group will receive insulin administration education according to standard procedures. They will not have access to the I-START app.
Behavioral: Standard Insulin Administration Education
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in psychological insulin resistance at 2 weeks
Time Frame: 2 weeks
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
2 weeks
Change from baseline in psychological insulin resistance at 3 months
Time Frame: 3 months
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
3 months
Change from baseline in psychological insulin resistance at 6 months
Time Frame: 6 months
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007). The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia. Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in glycemic control at 3 months
Time Frame: 3 months
Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control. HbA1c will serve as the clinical study outcome and measure of glycemic control. HbA1c values will be obtained from the electronic medical record (EMR) system.
3 months
Change from baseline in glycemic control at 6 months
Time Frame: 6 months
Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control. HbA1c will serve as the clinical study outcome and measure of glycemic control. HbA1c values will be obtained from the electronic medical record (EMR) system.
6 months
Change from baseline in medication adherence at 3 months
Time Frame: 3 months
Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). The scales includes 8 items. Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
3 months
Change from baseline in medication adherence at 6 months
Time Frame: 6 months
Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
6 months
Change from baseline in diabetes empowerment at 3 months
Time Frame: 3 months
Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment.
3 months
Change from baseline in diabetes empowerment at 6 months
Time Frame: 6 months
Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment.
6 months
Change from baseline in diabetes distress at 3 months
Time Frame: 3 months
Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
3 months
Change from baseline in diabetes distress at 6 months
Time Frame: 6 months
Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
6 months
Patient Satisfaction
Time Frame: 6 months
Patient satisfaction will be assessed using the validated Diabetes Medication System Rating Questionnaire-Short Form (DMSRQ-SF) (Peyrot et al, 2014). Items are scored 0 to 100; higher scores equal greater levels of item/construct being measured.
6 months
Provider Satisfaction
Time Frame: 6 months
Clinician experiences and perspectives on satisfaction of the app will be assessed through a study specific satisfaction survey
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Usability
Time Frame: 6 months
Patient usability will be tracked through the app's data analytics software platform. Study staff will pull data from the data analytics software platform.
6 months
Provider usability
Time Frame: 6 months
Clinician experiences and perspectives on the usability of the Briight app will be assessed a study specific usability survey.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linda Siminerio, RN, PhD, CDE, PROFESSOR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19040017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data set used for final analysis will be made available to other researchers who have obtained appropriate regulatory approval

IPD Sharing Time Frame

Data Set - After publication. ICF - After completing data collection.

IPD Sharing Access Criteria

Data set - other researchers will have to request access. ICF will be added to clinicaltrials.gov protocol

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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