Diabetes MellitusNCT05592860
Comparison of Glycemic Control With Smartphone Application
A study testing Mobile application and Daily Diary in people with Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Mobile application and Daily Diary
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2021to 2 Dec 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult type 2 diabetes mellitus patients (≥ 18years of age) whose HbA1c is ≥8% on insulin.
- At least three months of daily home glucose monitoring before including in the study
- Willing to provide consent to participate in the study4. Uses a smartphone with cellular network and willing to and has ability to learn and use the Vivo vitals application on it.
Who cannot join
- Patients who have Gestational diabetes or type 1 diabetes
- Patients who have been admitted to the hospital in the last month for more than 3 days.
- Patients who have adrenal disorders or taking exogenous glucocorticoids.
- Patients who are mentally incompetent, having uncontrolled psychiatric conditions, inmates.
- Patients with active malignancies including those on treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin
The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.
Read the detailed description
The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.
- Conditions
- Diabetes Mellitus
- Being tested
- Mobile application, Daily Diary
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationDevice
Also called device related insulin adjustment
participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly
Daily DiaryBehavioural
participants will use daily diary to record glucose level
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | Mobile application to enter glucose level Receives: Device: Mobile application |
| Daily Diary | Placebo comparator | Daily Diary to record glucose level Receives: Behavioral: Daily Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well a person is controlling their blood sugar to help prevent complications from diabetes.
Measured: at the end of 3 months follow-up
Secondary outcomes (3)
Change in weight
Change in weight
Measured: baseline and 3 month
Change in Body Mass Index (BMI)
Change in BMI
Measured: baseline and 3 month
Change in blood pressure
Change in blood pressure - systolic and diastolic
Measured: baseline and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start10 Jul 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Issac Sachmechi, Icahn School of Medicine at Mount Sinai
- Investigators
- Issac sachmechi, MD, FACE, FACP, Principal investigator, Icahn school of medicine Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592860
- Sponsor's protocol ID
- STUDY-20-01694
- Other IDs
- FWA#00005656, FWA#00005651
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin
- ClinicalTrials.gov ID
- NCT05592860
- Acronym / sponsor ID
- STUDY-20-01694
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 25 Oct 2022 (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 study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.
Detailed description
The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Device: Mobile applicationMobile application to enter glucose level |
| Daily Diary | Placebo comparator | Behavioral: Daily DiaryDaily Diary to record glucose level |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult type 2 diabetes mellitus patients (≥ 18years of age) whose HbA1c is ≥8% on insulin.
- At least three months of daily home glucose monitoring before including in the study
- Willing to provide consent to participate in the study4. Uses a smartphone with cellular network and willing to and has ability to learn and use the Vivo vitals application on it.
Key exclusion criteria (5 listed)
- Patients who have Gestational diabetes or type 1 diabetes
- Patients who have been admitted to the hospital in the last month for more than 3 days.
- Patients who have adrenal disorders or taking exogenous glucocorticoids.
- Patients who are mentally incompetent, having uncontrolled psychiatric conditions, inmates.
- Patients with active malignancies including those on treatment
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 |
|---|---|---|
| Mobile applicationAlso: device related insulin adjustmentparticipants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly | Device | Mobile application |
| Daily Diaryparticipants will use daily diary to record glucose level | Behavioural | Daily Diary |
Primary outcome
HbA1c
Time frame: at the end of 3 months follow-up
A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well a person is controlling their blood sugar to help prevent complications from diabetes.
3 secondary outcomes
Change in weight
Time frame: baseline and 3 month
Change in Body Mass Index (BMI)
Time frame: baseline and 3 month
Change in blood pressure
Time frame: baseline and 3 month
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 25 Oct 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Issac sachmechi, MD, FACE, FACP principal investigator
Icahn school of medicine Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application and Daily Diary in people with Diabetes Mellitus, run by Icahn School of Medicine at Mount Sinai 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 3 inclusion and 5 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 25 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
HbA1c (time frame: at the end of 3 months follow-up). 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 25 Oct 2022.