Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05975242 |
| Other study ID # |
IIS-000011 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 4, 2023 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Sansum Diabetes Research Institute |
| Contact |
Karla Gonzalez, RN |
| Phone |
8053350416 |
| Email |
kgonzalez[@]sansum.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to compare those using a diabetes management smartphone
application (mySugr) to those not using the application. This smartphone application is for
Spanish-literate adults with poorly controlled, non-intensively treated type 2 diabetes.
The main question[s] that it aims to answer are:
- What is the impact of the use of mySugr (a smartphone-based application or app) with
structured blood glucose monitoring on diabetes self-management among Hispanic/Latino
adults with poorly controlled, non-intensively treated T2D?
- Will diabetes self-management be more effective for those using mySugr (the Active
group) compared to those not using mySugr (the Control group) over a 12-week study
period? Participants will be screened and enrolled if they are eligible; they will have
the study explained to them in Spanish or English and have time to ask questions and
then sign an informed consent form. Clinical measurements (including height, weight, and
blood pressure) and hemoglobin A1c will be done. All subjects will be given a blood
glucose meter, lancing device, and blood glucose strips for the meter, and they will
also receive an electronic scale. Several questionnaires will be answered.
If a subject is randomly assigned to the Active group, they will download the mySugr Pro app
in Spanish to their smartphone and be trained in its use. They will receive education focused
on paired (before and 2 hours after a meal) blood glucose testing, which participants will
conduct twice a day for 6 days and once a month for 3 months. Participants will continue
structured blood glucose testing with the mySugr PRO app for 12 weeks, and they will have 3
virtual visits in Spanish with mySugr PRO coaches who will review the blood glucose records
and advise the subjects.
Subjects in the Control group will not receive the mySugr PRO app or coaching. They will
continue with their usual diabetes management.
All subjects will return after 12 weeks to return the scale and have a close-out visit with
clinical measurements and questionnaires. Subjects will also receive a disturbance allowance
for their time and participation.
Description:
The aim of this pilot observation trial is to determine feasibility, acceptability, and
impact of the combination of mySugr and structured SMBG for Spanish-literate Hispanic/Latino
adults with poorly controlled T2D. The study will be single site (Sansum Diabetes Research
Institute - SDRI), prospective data collection, with pre- and post-intervention comparison. A
total of 30 people with T2D will be randomly allocated (2:1 randomization) to the
interventional group (n = 20) that will use the digital self-management application during
the 12-week study period or the control group (n = 10) without the app. Pre- and
post-intervention assessments will measure diabetes distress as well as self-efficacy to
manage diabetes, HbA1c, weight, and blood glucose. MySugr app perceived usefulness, ease of
use, content, efficacy, and usability will be measured post-intervention. To maximize
retention, both participant groups will receive a disturbance allowance as they progress
through the study.
Spanish-literate Hispanic/Latino adults with T2D and HbA1c 7.5% - 10% and who reside in the
Central Coast of California and currently use a compatible smartphone will be enrolled.
Study interaction and procedures will be conducted in Spanish by an existing, trusted
bilingual Hispanic/Latino Certified Diabetes Educator (CDE) and SDRI Community Scientists.
Following informed consent, participants will be randomly assigned to the interventional
group that will use the digital self-management application during the 12-week study period
or the control group that will not use the app. The interventional group will be trained in
the use of the mySugr app and receive education focusing on SMBG based on paired (before and
2 hours after a meal) BG testing, which participants will conduct twice daily for 6 days once
monthly for 3 months. Participants will continue structured SMBG with mySugr PRO for 12 weeks
and will have access to mySugr proactive coaching consisting of 3 virtual engagements focused
on reviewing and reacting to participant-derived structured SMBG data.
At Visit 1, vital signs health measurements (height, weight, waist circumference and resting
blood pressure) will be conducted by trained clinical staff, and fingerstick HbA1c will be
measured using the Abbott Afinion 2 Point of Care (POC) Analyzer or FDA-approved equivalent.
Several questionnaires will be completed. Subjects will measure their blood glucose at home
using the Accu Check Guide Me blood glucose meter and their weight at home using a smartphone
connected weight scale.
If subjects are randomized to the Active or intervention group, they will download and be
trained in the use of the mySugr app. Active group participants will be asked to use the
mobile application throughout the duration of the study. The app will be used to collect data
from glucometers in their mobile phones and to have access to mySugr proactive coaching. The
coach visits will be conducted in Spanish with a duration of 30-minutes each month and
focusing on reviewing and reacting to participant derived structured SMBG data. In the
control group, people with diabetes will neither have access to the mySugr Pro app nor
coaching during the 12-week Intervention Period; they will continue with their usual,
discretionary mode of therapy, data documentation, and glucose monitoring.
After 12 weeks, subjects will complete a second and final visit with vital signs, HbA1c, and
questionnaires repeated. A disturbance allowance will be given to each subject for their time
and participation.
