Diabetes Mellitus, Type 2mySugrNCT05975242
Acceptability & Impact of a Diabetes Management Smartphone App (mySugr) for Spanish-literate Adults With Type 2 Diabetes
A study testing Smartphone diabetes management application in people with Diabetes Mellitus, Type 2, run by Sansum Diabetes Research Institute at 1 site in United States.
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 (T2D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Smartphone diabetes management application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age at enrollment
- Self-reported Hispanic/Latino ethnicity
- Spanish-literate with Spanish as preferred language
- Diagnosis of T2D for at least 6 months
- HbA1c 7.5% - 10%
- mySugr-compatible smartphone
- Any glucose lowering therapy except rapid-acting mealtime insulin
- Residence in Central Coast of California -
Who cannot join
- 1. Type 1 diabetes 2. Use of rapid-acting mealtime insulin 3. Pregnancy 4. Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: Acceptability and Impact of the Proactive Use of a Diabetes Management Smartphone Application (mySugr) for Spanish-literate Adults With Poorly Controlled Non-intensively Treated Type 2 Diabetes
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 (T2D).
The main question[s] that it aims to answer are:
Read more
- 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 (professional) 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.
Read the detailed description
The aim of this pilot observation trial is to determine feasibility, acceptability, and impact of the combination of mySugr and structured self-monitored blood glucose (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) blood glucose (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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Smartphone diabetes management application
- Keywords
- Hispanic/Latino, smartphone application, self-monitoring blood glucose, Spanish, mySugr PRO
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone diabetes management applicationBehavioural
Also called mySugr
The intervention is a smartphone diabetes management application that is combined with structured blood glucose testing.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | The interventional group will use the digital self-management smartphone application during the 12-week study period and will have access to 3 coaching sessions. The interventional group will be trained in the use of the app and receive education focused on self-monitoring blood glucose based on paired (before and 2 hours after a meal) blood glucose testing, which participants will conduct twice daily for 6 days once monthly for 3 months. Receives: Behavioral: Smartphone diabetes management application |
| Control group | No intervention | The control group will not have use of the digital self-management smartphone application during the 12-week study period and will not have access to 3 coaching sessions. No structured self-monitoring blood glucose testing will be done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spanish-language Diabetes Self-Efficacy Scale (DSES-S)
A scale of 8 Likert-type 10-point items to measure self-efficacy of diabetes self-management
Measured: Visit 1, week 1 and Visit 2, week 12
Secondary outcomes (4)
Hemoglobin A1c
A measure of glycosylated hemoglobin
Measured: Visit 1, week 1 and Visit 2, week 12
Problem areas in diabetes (PAID) scale
The Problem Areas in Diabetes (PAID) instrument was developed to measure emotional distress in people with diabetes. It is a 20-item scale consisting of emotional problems commonly reported in type 1 and type 2 diabetes mellitus, and has been found to be a valid and reliable scale in Western populations.
Measured: Visit 1, week 1 and Visit 2, week 12
Blood glucose measurements
Blood glucose measurements made with the assigned glucose meter at specific times
Measured: Week 1, Week 4, Week 8
Weight
Body weight in kilograms
Measured: Visit 1, week 1 and Visit 2, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start4 Apr 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be single site, 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Ashley Thorsell, MD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975242
- Sponsor's protocol ID
- IIS-000011
- Acronym
- mySugr
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Impact of the Proactive Use of a Diabetes Management Smartphone Application (mySugr) for Spanish-literate Adults With Poorly Controlled Non-intensively Treated Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05975242
- Acronym / sponsor ID
- mySugr / IIS-000011
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Hispanic/Latino, smartphone application, self-monitoring blood glucose, Spanish, mySugr PRO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (T2D).
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 (professional) 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.
Detailed description
The aim of this pilot observation trial is to determine feasibility, acceptability, and impact of the combination of mySugr and structured self-monitored blood glucose (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) blood glucose (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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be single site, 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Smartphone diabetes management applicationThe interventional group will use the digital self-management smartphone application during the 12-week study period and will have access to 3 coaching sessions. The interventional group will be trained in the use of the app and receive education focused on self-monitoring blood glucose based on paired (before and 2 hours after a meal) blood glucose testing, which participants will conduct twice daily for 6 days once monthly for 3 months. |
| Control group | No intervention | –The control group will not have use of the digital self-management smartphone application during the 12-week study period and will not have access to 3 coaching sessions. No structured self-monitoring blood glucose testing will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults ≥ 18 years of age at enrollment
- Self-reported Hispanic/Latino ethnicity
- Spanish-literate with Spanish as preferred language
- Diagnosis of T2D for at least 6 months
- HbA1c 7.5% - 10%
Key exclusion criteria (2 listed)
- 1. Type 1 diabetes 2. Use of rapid-acting mealtime insulin 3. Pregnancy 4. Any active clinically significant disease or disorder which in the investigator's opinion could interfere with participation in the study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone diabetes management applicationAlso: mySugrThe intervention is a smartphone diabetes management application that is combined with structured blood glucose testing. | Behavioural | Interventional group |
Primary outcome
Spanish-language Diabetes Self-Efficacy Scale (DSES-S)
Time frame: Visit 1, week 1 and Visit 2, week 12
A scale of 8 Likert-type 10-point items to measure self-efficacy of diabetes self-management
4 secondary outcomes
Hemoglobin A1c
Time frame: Visit 1, week 1 and Visit 2, week 12
Problem areas in diabetes (PAID) scale
Time frame: Visit 1, week 1 and Visit 2, week 12
Blood glucose measurements
Time frame: Week 1, Week 4, Week 8
Weight
Time frame: Visit 1, week 1 and Visit 2, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Thorsell, MD principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone diabetes management application in people with Diabetes Mellitus, Type 2, run by Sansum Diabetes Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spanish-language Diabetes Self-Efficacy Scale (DSES-S) (time frame: Visit 1, week 1 and Visit 2, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.