Glooko mHealth Advantage Study

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Glooko Diabetes Mobile Monitoring and Management Advantage Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974816
• Other study ID #: GL1
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: April 17, 2020

Study information

• Verified date: June 2021
• Source: Glooko
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: April 17, 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• Glooko's mobile application
Standard of care and Remote monitoring

Locations

Country	Name	City	State
United States	Billings Clinic	Billings	Montana
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	Sutter Health	Elk Grove	California
United States	Scripps Whittier Diabetes Institute	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Glooko

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. Erratum in: Diabetes Care. 2011 Oct;34(10):2338. — View 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. — View Citation

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. — View 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. Erratum in: Diabetes Care. 2013 Nov;36(11):3850. — View Citation

Standards of medical care in diabetes--2015: summary of revisions. Diabetes Care. 2015 Jan;38 Suppl:S4. doi: 10.2337/dc15-S003. — View Citation

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. Erratum in: BMJ 1999 Jan 2;318(7175):29. — View 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. — View Citation

Outcome

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