Diabetes Mellitus, Type 2
Conditions
Keywords
Glooko, Mobile health application, Insulin treated, Type 2 Diabetes, Remote patient monitoring, Certified diabetes educator, mHealth Advantage, Population health
Brief summary
The purpose of this study is to compare HbA1c of insulin-treated subjects with type 2 diabetes managed via usual care alone and usual care augmented with remote monitoring using Glooko
Detailed description
In this study, the investigator wants to evaluate if diabetes self-management supported by a mobile application, which captures a subject's blood glucose readings, lifestyle and medication information and shares it with the subject's certified diabetes educator (CDE) to enable remote monitoring, improves their glycemic control compared to standard of care.
Interventions
DEVICEGlooko's mobile application
Standard of care and Remote monitoring
Sponsors
Glooko
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act (HIPAA) or other privacy authorization prior to any participation in study. 2. Subject has self-reported type 2 diabetes. 3. Subject has HbA1c ≥ 7.5% and ≤ 12.5% measured within 30 days of screening visit. 4. Subject is on a stable diabetes therapeutic regimen of two or more diabetic medications (e.g., metformin plus one other antihyperglycemic agent) and/or insulin therapy for at least 2 months before screening visit. Dose changes or adjustments made within 2 months is acceptable as long as the patient has been on the medication regimen for 2 months or longer. 5. Subject is ≥ 18 and ≤ 75 years of age. 6. Subject is a male or non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). 7. If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study): 1. Condoms, sponge, diaphragm, or intrauterine device; 2. Oral or parenteral contraceptives for 3 months prior to screening visit; 3. Vasectomized partner; 4. Total abstinence from sexual intercourse 8. Subject is able to speak, read and write in English 9. Subject has a Glooko compatible smartphone/device with an active data plan or access to Wi-Fi and downloaded at least one mobile application on their phone on their own. 10. Subject has performed self-monitoring of blood glucose at least five (5) times within two (2) weeks prior to screening visit.
Exclusion criteria
1. Subject has type 1 diabetes. 2. Subject has advanced disease (physical or psychological) that would prevent them from being able to comply with study tasks and considered exclusionary by the study physicians. 3. Subject has been on medication or therapy within the last 2 months that severely affects blood glucose levels (e.g. corticosteroids). 4. Subject has visual impairment which severely limits his/her ability to see or use the mobile application. 5. Subject is a participant in another clinical study that has not been approved as a concomitant study by Glooko.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from baseline | 24 weeks | Change in HbA1c from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving </=7% | 12 and 24 weeks | Percentage of patients achieving \</=7% |
| Basal insulin dose(Change from baseline) | 12 and 24 weeks | Basal insulin dose(Change from baseline) |
| Bolus insulin dose(Change from baseline) | 12 and 24 weeks | Bolus insulin dose(Change from baseline) |
| Change in Total insulin dose(Change from baseline) | 12 and 24 weeks | Change in Total insulin dose(Change from baseline) |
| Weight(Change from baseline) | 12 and 24 weeks | Weight(Change from baseline) |
| Change in HbA1c from baseline | 12 weeks | Change in HbA1c from baseline |
| Rate of hypoglycemic events (blood glucose level <70mg/dL) | 12 and 24 weeks | Rate of hypoglycemic events (blood glucose level \<70mg/dL) |
| Self-monitoring blood glucose frequency | 12 and 24 weeks | Self-monitoring blood glucose frequency |
| Mean blood glucose concentration(Change from baseline) | 12 and 24 weeks | Mean blood glucose concentration(Change from baseline) |
| Number of ER visits(Change from baseline) | 12 and 24 weeks | Number of ER visits(Change from baseline) |
| Number of hospitalizations(Change from baseline) | 12 and 24 weeks | Number of hospitalizations(Change from baseline) |
| Problem Areas in Diabetes score(Change from baseline) | 12 and 24 weeks | Problem Areas in Diabetes score(Change from baseline) |
Countries
United States
Outcome results
None listed