Glooko mHealth Advantage Study

NCT02974816 | Completed FDA Device

• 1 other identifier: GL1
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 4

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

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline

  Change in HbA1c from baseline

  24 weeks

Secondary Outcomes (12)

• Change in HbA1c from baseline

  12 weeks

• Percentage of patients achieving </=7%

  12 and 24 weeks

• Basal insulin dose(Change from baseline)

  12 and 24 weeks

• Bolus insulin dose(Change from baseline)

  12 and 24 weeks

• Change in Total insulin dose(Change from baseline)

  12 and 24 weeks

Study Arms (2)

Standard of Care

NO INTERVENTION

Subjects in this arm will visit their physician once every 3 months and will receive usual care.

Remote Monitoring

EXPERIMENTAL

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

Interventions

Glooko's mobile application DEVICE

Standard of care and Remote monitoring

Also known as: Glooko's Population Tracker, Meter Sync Blue

Remote Monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject has type 1 diabetes.
• 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.

Sponsors & Collaborators

• Glooko: lead

Study Sites (4)

John Muir Physician Network Clinical Research Center

Concord, California, 94520, United States

Location

Sutter Health

Elk Grove, California, 95758, United States

Location

Scripps Whittier Diabetes Institute

San Diego, California, 92121, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Related Publications (8)

• Huang ES, Basu A, O'Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the U.S. Diabetes Care. 2009 Dec;32(12):2225-9. doi: 10.2337/dc09-0459.

  PMID: 19940225 BACKGROUND

• 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.

  PMID: 19017771 BACKGROUND

• 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.

  PMID: 21788632 BACKGROUND

• 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.

  PMID: 25537706 BACKGROUND

• 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.

  PMID: 18474888 BACKGROUND

• 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.

  PMID: 9135939 BACKGROUND

• 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.

  PMID: 9732337 BACKGROUND

• 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.

  PMID: 23468086 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Greenfield, MD

  Glooko

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: May 15, 2017
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)