Glooko mHealth Advantage Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Glooko Diabetes Mobile Monitoring and Management Advantage Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Glooko's mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Subject has self-reported type 2 diabetes. Subject has HbA1c ≥ 7.5% and ≤ 12.5% measured within 30 days of screening visit. 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. Subject is ≥ 18 and ≤ 75 years of age. 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). 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): Condoms, sponge, diaphragm, or intrauterine device; Oral or parenteral contraceptives for 3 months prior to screening visit; Vasectomized partner; Total abstinence from sexual intercourse Subject is able to speak, read and write in English 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. Subject has performed self-monitoring of blood glucose at least five (5) times within two (2) weeks prior to screening visit. Exclusion Criteria: Subject has type 1 diabetes. 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. Subject has been on medication or therapy within the last 2 months that severely affects blood glucose levels (e.g. corticosteroids). Subject has visual impairment which severely limits his/her ability to see or use the mobile application. Subject is a participant in another clinical study that has not been approved as a concomitant study by Glooko.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Subjects in this arm will visit their physician once every 3 months and will receive usual care. | |
| Experimental: Remote Monitoring<br>Subjects in this arm will visit their physician once every 3 months and will receive usual care. In addition, in between clinic visits, subjects will measure their blood glucose (BG) readings at least once a day and share their BG readings with their CDE using Glooko's mobile application. Once a week, the CDE will review the subject's BG readings on Glooko's population tracker and reach out to the subjects if he/she experienced clinical incident(s). During the conversation, the CDE will either recommend medication or lifestyle modification to address the clinical incident. | Device: Glooko's mobile application<br>* Standard of care and Remote monitoring<br>* Other names: Glooko's Population Tracker, Meter Sync Blue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline | Change in HbA1c from baseline | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline | Change in HbA1c from baseline | 12 weeks | 
| Percentage of patients achieving </=7% | Percentage of patients achieving </=7% | 12 and 24 weeks | 
| Basal insulin dose(Change from baseline) | Basal insulin dose(Change from baseline) | 12 and 24 weeks | 
| Bolus insulin dose(Change from baseline) | Bolus insulin dose(Change from baseline) | 12 and 24 weeks | 
| Change in Total insulin dose(Change from baseline) | Change in Total insulin dose(Change from baseline) | 12 and 24 weeks | 
| Weight(Change from baseline) | Weight(Change from baseline) | 12 and 24 weeks | 
| Problem Areas in Diabetes score(Change from baseline) | Problem Areas in Diabetes score(Change from baseline) | 12 and 24 weeks | 
| Rate of hypoglycemic events (blood glucose level <70mg/dL) | Rate of hypoglycemic events (blood glucose level <70mg/dL) | 12 and 24 weeks | 
| Self-monitoring blood glucose frequency | Self-monitoring blood glucose frequency | 12 and 24 weeks | 
| Mean blood glucose concentration(Change from baseline) | Mean blood glucose concentration(Change from baseline) | 12 and 24 weeks | 
| Number of ER visits(Change from baseline) | Number of ER visits(Change from baseline) | 12 and 24 weeks | 
| Number of hospitalizations(Change from baseline) | Number of hospitalizations(Change from baseline) | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glooko, Mobile health application, Insulin treated, Type 2 Diabetes, Remote patient monitoring, Certified diabetes educator, mHealth Advantage, Population health