Insulin Start Therapy Application With Resources and Training

NCT ID: NCT03999268

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2022-05-25

Brief Summary

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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

I-START

Intervention Type: BEHAVIORAL

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.

Standard Insulin Administration Education

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Insulin Administration Education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Linda Siminerio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Siminerio, RN, PhD, CDE

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Krall JS, Childs B, Mehrotra N. Mobile Applications to Support Diabetes Self-Management Education: Patient Experiences and Provider Perspectives. J Diabetes Sci Technol. 2023 Sep;17(5):1206-1211. doi: 10.1177/19322968231174037. Epub 2023 May 10.

Reference Type: DERIVED

PMID: 37162000 (View on PubMed)

Other Identifiers

STUDY19040017

Identifier Type: -

Identifier Source: org_study_id