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

University of Pittsburgh

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Standard Insulin Administration Education; Behavioral: I-START

Study type: Interventional

Funder types: Other

Identifiers

NCT03999268

STUDY19040017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Insulin Administration Education

Behavioral: I-START

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Insulin Administration Education