Clinical trial NCT03999268: Insulin Start Therapy Application With Resources and Training
Official title: Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Psychological insulin resistance
Diabetes self-management
Mobile application
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change from baseline in psychological insulin resistance at 2 weeks
timeFrame: 2 weeks
measure: Change from baseline in psychological insulin resistance at 3 months
timeFrame: 3 months
measure: Change from baseline in psychological insulin resistance at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in glycemic control at 3 months
timeFrame: 3 months
measure: Change from baseline in glycemic control at 6 months
timeFrame: 6 months
measure: Change from baseline in medication adherence at 3 months
timeFrame: 3 months
measure: Change from baseline in medication adherence at 6 months
timeFrame: 6 months
measure: Change from baseline in diabetes empowerment at 3 months
timeFrame: 3 months
measure: Change from baseline in diabetes empowerment at 6 months
timeFrame: 6 months
measure: Change from baseline in diabetes distress at 3 months
timeFrame: 3 months
measure: Change from baseline in diabetes distress at 6 months
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 6 months
measure: Provider Satisfaction
timeFrame: 6 months
Other outcomes:
measure: Patient Usability
timeFrame: 6 months
measure: Provider usability
timeFrame: 6 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Professor
name: Linda Siminerio, RN, PhD, CDE
role: PRINCIPAL_INVESTIGATOR
References: