- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03999268
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
41
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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 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.
|
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
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
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
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
Investigators
- 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)
November 25, 2019
Primary Completion (Actual)
May 25, 2022
Study Completion (Actual)
May 25, 2022
Study Registration Dates
First Submitted
June 21, 2019
First Submitted That Met QC Criteria
June 25, 2019
First Posted (Actual)
June 26, 2019
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on I-START
-
The First Affiliated Hospital of Dalian Medical...LanZhou University; Fudan University; Beijing Friendship Hospital; Chinese PLA... and other collaboratorsActive, not recruitingChronic Kidney DiseaseChina
-
M.D. Anderson Cancer CenterNot yet recruitingDyspneaUnited States
-
University of Alabama at BirminghamNot yet recruitingPediatric CancerUnited States
-
University of ArizonaNational Cancer Institute (NCI); Michigan State UniversityCompleted
-
University of California, San FranciscoCompleted
-
University Hospital, GasthuisbergKU Leuven; Kom Op Tegen Kanker; Research Foundation FlandersRecruitingPostoperative Complications | Muscle Weakness | Esophageal Cancer | Sarcopenia | Nutrition Aspect of Cancer | Jejunostomy; ComplicationsBelgium
-
University of MiamiNot yet recruitingMental Health Wellness 1United States
-
Karolinska InstitutetCompletedOut-Of-Hospital Cardiac Arrest | Cardiac Arrest, SuddenSweden
-
University of California, San FranciscoWithdrawnMorbid Obesity