Clinical trial NCT02974816: Glooko mHealth Advantage Study
Official title: The Glooko Diabetes Mobile Monitoring and Management Advantage Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Glooko
Mobile health application
Insulin treated
Type 2 Diabetes
Remote patient monitoring
Certified diabetes educator
mHealth Advantage
Population health
Lead sponsor: Glooko
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in HbA1c from baseline
timeFrame: 12 weeks
measure: Percentage of patients achieving </=7%
timeFrame: 12 and 24 weeks
measure: Basal insulin dose(Change from baseline)
timeFrame: 12 and 24 weeks
measure: Bolus insulin dose(Change from baseline)
timeFrame: 12 and 24 weeks
measure: Change in Total insulin dose(Change from baseline)
timeFrame: 12 and 24 weeks
measure: Weight(Change from baseline)
timeFrame: 12 and 24 weeks
measure: Problem Areas in Diabetes score(Change from baseline)
timeFrame: 12 and 24 weeks
measure: Rate of hypoglycemic events (blood glucose level <70mg/dL)
timeFrame: 12 and 24 weeks
measure: Self-monitoring blood glucose frequency
timeFrame: 12 and 24 weeks
measure: Mean blood glucose concentration(Change from baseline)
timeFrame: 12 and 24 weeks
measure: Number of ER visits(Change from baseline)
timeFrame: 12 and 24 weeks
measure: Number of hospitalizations(Change from baseline)
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Elk Grove
country: United States
facility: Sutter Health
state: California
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: Billings
country: United States
facility: Billings Clinic
state: Montana
Study officials:
affiliation: Glooko
name: Michael Greenfield, MD
role: STUDY_DIRECTOR
References:
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citation: Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, Williams DE, Gregg EW, Bainbridge KE, Saydah SH, Geiss LS. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009 Feb;32(2):287-94. doi: 10.2337/dc08-1296. Epub 2008 Nov 18.
citation: Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011 Sep;34(9):1934-42. doi: 10.2337/dc11-0366. Epub 2011 Jul 25.
citation: Standards of medical care in diabetes--2015: summary of revisions. Diabetes Care. 2015 Jan;38 Suppl:S4. doi: 10.2337/dc15-S003. No abstract available.
citation: Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
citation: Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997 May;20(5):760-6. doi: 10.2337/diacare.20.5.760.
citation: UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ. 1998 Sep 12;317(7160):703-13.
citation: American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.