- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04550585
Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes (STEPP-UP)
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Education: Session 1 - Basics of type 1 management
- Other: Session 2 - Carbohydrate counting
- Other: Education: Session 3 - Insulin self- adjustment
- Other: Education: Session 4 - Sick day rules and physical activity dose adjustments
- Other: Education: Session 5 - Starting the insulin pen (for pen users) or pump (for pump users)
- Other: Education: Session 6 - Trouble shooting the pump (for pump users)
Detailed Description
SUMMARY OF STUDY RATIONAL - Lower socioeconomic status (SES) individuals with type 1 diabetes (T1D) have poorer outcomes than wealthier patients and part of this disparity comes from a lack of tools and knowledge about how to teach these patients on the technologies other patients take for granted. Until recently many of these lower SES individuals did not have access to health insurance, but with the implementation of the Affordable Care Act the group with the greatest expansion of coverage is the young adult age group (ages 18 - 34), particularly in the Latino community. Increased insurance allows for access to newer technology including insulin pens and pumps. As these patients have not had access to such devices, low literacy educational tool are necessary for safe and efficient utilization. Therefore, this is a study designed to develop and test low literacy English/Spanish language teaching tools for patients with type 1 diabetes treated with varying types of technology in the Los Angeles County (LAC) healthcare system. This study is a single center pilot study and by the nature of our clinic setting it cannot be a randomized controlled trial - it is more of a naturalistic experiment comparing each patient to their prior state of glycemic control with their status after the educational intervention using low-literacy educational materials has been applied.
INTERVENTION - Baseline Visit: Participants will sign informed consent, complete questionnaires, and measure HbA1C. Those opting to do so will start a continuous glucose monitor (CGM) sensor. All patients will be provided the written low literacy teaching tools in the language of their choice.
CGM Visit - for those opting to wear CGM will occur at Week 2 where 14 days of CGM data will be downloaded from participants' device.
Education Sessions: Educational sessions will be conducted using the low-literacy tools we created. Classes will be available on Fridays during T1D Clinic and on Saturdays to maximize participation. Classes will be every two weeks for approximately 3 months. Classes will be approximately 1 ½ hours in duration. Patients will be encouraged but not required to attend the classes. However, those starting on the pen and/or pump will be asked to attend the relevant sessions to prepare them for use of the technology.
Educational Sessions:
Session 1 - Basics of type 1 management Session 2 - Carbohydrate counting, Session 3 - Insulin self- adjustment, Session 4 - Sick day rules and physical activity dose adjustments Session 5 - Starting the insulin pen (for pen users) or pump (for pump users) Session 6 - Trouble shooting the pump (for pump users)
Phone Calls - Each patient will be contacted monthly (baseline month up to month 3 visit) by the diabetes educator to follow-up on questions and concerns regarding their diabetes management.
Clinic Visit 2 - post education visit will occur at 3 months. Questionnaires will be administered, A1C measured and CGM data and compare to baseline.
Clinic Visit 3 - will occur at 6 months. Questionnaires will be administered, A1C measured and CGM data and compare to baseline.
Clinic Visit 4 -will occur at 12 months. Questionnaires will be administered, A1C measured and CGM data and compare to baseline and 6 months.
DATA COLLECTION AND TESTING PROCEDURES (Baseline, 6 months and 12 months) HbA1c - HbA1c will be obtained using the point of care Siemens DCA Vantage Analyzer.
Continuous Glucose Monitoring (CGM)- A commercially available DexCom G5 or Libre device will be provided and a sensor will be inserted. The participant will receive instructions on calibration, insertions, maintenance, use, and removal of the sensor.
T1D REDEEM Diabetes Distress Questionnaire- The T1D REDEEM Diabetes Distress Questionnaire measures several dimensions of stress related to having type 1 diabetes. It consists of the following 7 subscales: Subscale 1 - Powerlessness (5 items); Subscale 2 - Management Distress (4 items); Subscale 3 - Hypoglycemia Distress (4 items); Subscale 4 - Negative Social Perceptions (4 items); Subscale 5 - Eating Distress (3 items); Subscale 6 - Physician Distress (4 items); Subscale 7 - Friend/Family Distress (4 items). Each question has a 6-choice Likert response format. Administration time is approximately 10 minutes.
Hypoglycemia Fear Survey - The Hypoglycemia Fear Survey measures several dimensions of fear of hypoglycemia among adults with type 1 diabetes. It consists of a 10-item Behavior subscale that measured behaviors involved in avoidance and over-treatment of hypoglycemia and a 13-item Worry subscale that measures anxiety and fear surrounding hypoglycemia, each with a 5-choice Likert response format. Administration time is approximately 10 minutes.
Simplified Diabetes Knowledge Test -The Simplified Diabetes Knowledge Test consists of 23 knowledge test items developed by the Michigan Diabetes Research Training Center (MDRTC). These items represent a test of general knowledge of diabetes and are answered in a true/false/don't know format. The psychometric properties provide information regarding the reliability of the various groups of items, as well as a difficulty index (percent of patients who scored this item correctly), and an item to group total correlation for each item. These data can be reported when describing the use of the test. Administration time is approximately 15 minutes.
Assessment of Sever Hypoglycemia and Diabetic Ketoacidosis -The Assessment of Severe Hypoglycemia and Diabetic Ketoacidosis is an interviewer administered survey assessing if the subject had any episodes of severe hypoglycemia and/or diabetic ketoacidosis since their last study visit. Events are recorded to assess frequency, as is type of assistance required to treat the event. Administration time is approximately 5 minutes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90022
- University of Southern California Eastside Center for Diabetes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of type 1 diabetes
- Age 18 - 75 years old
- Currently being treated at the T1D clinic in the LAC/USC Healthcare System
- No use of CSII or insulin pen in the past 6 months
- No serious illnesses where life expectancy is <1 year
- Understand the study requirements and agree to comply with all study visits and procedures.
- Fluent in English or Spanish
Exclusion Criteria:
- Subject is currently pregnant or lactating or plan on becoming pregnant during the course of the study.
- Subject is Blind
- Subject cannot follow instructions due to a medical condition or mental illness.
- Subject has a known allergy to medical adhesive.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low-literacy based education on HbA1c
Time Frame: 12-months
|
Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 12 months
|
12-months
|
Low-literacy based education on hypoglycemia
Time Frame: 12 months
|
Number of patients with decreased hypoglycemia as measured by self report from baseline to 12 months
|
12 months
|
Low-literacy based education on diabetic ketoacidosis
Time Frame: 12 months
|
Number of patients with decreased diabetic ketoacidosis as measured by self report from baseline to 12 months
|
12 months
|
Low-literacy based education on hypoglycemia fear
Time Frame: 12 months
|
Number of patients with decreased hypoglycemia fear as measured by the Hypoglycemia Fear Survey from baseline to 12 months
|
12 months
|
Low-literacy based education on diabetes knowledge
Time Frame: 12 months
|
Number of patients with increased as measured by the Simplified Diabetes Knowledge Test from baseline to 12 months
|
12 months
|
Low-literacy based education on diabetes distress
Time Frame: 12 months
|
Number of patients with decreased diabetes distress as measured by Type 1 Diabetes Reducing Distress and Enhancing Effective Management diabetes distress scale from baseline to 12 months
|
12 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEPP-UP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Type1diabetes
-
Silesian Centre for Heart DiseasesThe Jerzy Kukuczka Academy of Physical Education in KatowiceCompletedtype1diabetesPoland
-
Vastra Gotaland RegionCompletedType1diabetesSweden
-
Rabin Medical CenterThe Leona M. and Harry B. Helmsley Charitable Trust; DreaMed DiabetesRecruiting
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)Active, not recruiting
-
Aalborg University HospitalAalborg University; Steno Diabetes Center NordjyllandCompletedType1diabetes | Hemodialysis | Type2DiabetesDenmark
-
Vastra Gotaland RegionRecruitingType1diabetes | Psychology Functional BehaviorSweden
-
Radboud University Medical CenterUnknownType1diabetes | Hypoglycemia UnawarenessNetherlands
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Active, not recruitingHypoglycemia | Type1diabetes | Islet Cell Transplantation | Hypoglycemia UnawarenessUnited States
-
University of British ColumbiaJuvenile Diabetes Research Foundation; Brain CanadaNot yet recruiting
-
Pacific Diabetes TechnologiesRecruiting
Clinical Trials on Education: Session 1 - Basics of type 1 management
-
Kessler FoundationeMindful.comCompletedChronic Pain | Spinal Cord InjuriesUnited States
-
Daniela MogaCompletedAlzheimer DiseaseUnited States
-
Kessler FoundationThe Craig H. Neilsen Foundation; Kessler Institute for RehabilitationCompletedChronic Pain | Spinal Cord InjuryUnited States
-
Second Xiangya Hospital of Central South UniversityCompleted
-
Second Xiangya Hospital of Central South UniversityRecruitingDiabetes | Type1diabetesChina
-
Instituto de Cardiologia do Rio Grande do SulRecruiting
-
Akdeniz UniversityRecruitingSelf Efficacy | Adolescent Behavior | type1diabetesTurkey
-
Assistance Publique Hopitaux De MarseilleCompletedChildren With Cochlear ImplantFrance
-
Ohio University College of Osteopathic MedicineCompleted
-
University of British ColumbiaVancouver General Hospital; Arthritis Research Centre of CanadaCompletedJoint Diseases | Knee OsteoarthritisCanada