Insulin Start Therapy Application With Resources and Training

NCT03999268 | Completed

• 1 other identifier: STUDY19040017
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Psychological insulin resistance; Diabetes self-management; Mobile application

Outcome Measures

Primary Outcomes (3)

• Change from baseline in psychological insulin resistance at 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

  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

  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 Outcomes (10)

• Change from baseline in glycemic control at 3 months

  3 months

• Change from baseline in glycemic control at 6 months

  6 months

• Change from baseline in medication adherence at 3 months

  3 months

• Change from baseline in medication adherence at 6 months

  6 months

• Change from baseline in diabetes empowerment at 3 months

  3 months

Other Outcomes (2)

• Patient Usability

  6 months

• Provider usability

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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; Behavioral: Standard Insulin Administration Education

Usual Care

ACTIVE COMPARATOR

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

Interventions

I-START 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.

Intervention

Standard Insulin Administration Education 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.

Intervention; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 37162000 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Linda Siminerio, RN, PhD, CDE

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 26, 2019
• Study Start: November 25, 2019
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data Set - After publication. ICF - After completing data collection.
• Access Criteria: Data set - other researchers will have to request access. ICF will be added to clinicaltrials.gov protocol

Locations

US (1)