Diabetes Mellitus
Conditions
Brief 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.
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.
Interventions
DEVICEMobile application
participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly
BEHAVIORALDaily Diary
participants will use daily diary to record glucose level
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | baseline and 3 month | Change in weight |
| Change in Body Mass Index (BMI) | baseline and 3 month | Change in BMI |
| Change in blood pressure | baseline and 3 month | Change in blood pressure - systolic and diastolic |
Countries
United States
Outcome results
None listed