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Diabetes Mellitus, Type 2NCT02974816

Glooko mHealth Advantage Study

A study testing Glooko's mobile application in people with Diabetes Mellitus, Type 2, run by Glooko at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Glooko's mobile application
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
4 sitesUnited States
Study dates
15 May 2017to 17 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Billings Clinic

    Billings, Montana, 59101

  • John Muir Physician Network Clinical Research Center

    Concord, California, 94520

  • Sutter Health

    Elk Grove, California, 95758

  • Scripps Whittier Diabetes Institute

    San Diego, California, 92121

Other trials in United States

About this study

Official title: The Glooko Diabetes Mobile Monitoring and Management Advantage Study

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

Read the 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.

Being tested
Glooko's mobile application
Keywords
Glooko, Mobile health application, Insulin treated, Type 2 Diabetes, Remote patient monitoring, Certified diabetes educator, mHealth Advantage, Population health
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glooko's mobile applicationDevice

    Also called Glooko's Population Tracker, Meter Sync Blue

    Standard of care and Remote monitoring

Study groups in NCT02974816
Study groupRoleWhat they receive
Standard of CareNo interventionSubjects in this arm will visit their physician once every 3 months and will receive usual care.
Remote MonitoringExperimentalSubjects 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.
Receives: Device: Glooko's mobile application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c from baseline

    Change in HbA1c from baseline

    Measured: 24 weeks

Secondary outcomes (12)

  1. Change in HbA1c from baseline

    Change in HbA1c from baseline

    Measured: 12 weeks

  2. Percentage of patients achieving </=7%

    Percentage of patients achieving </=7%

    Measured: 12 and 24 weeks

  3. Basal insulin dose(Change from baseline)

    Basal insulin dose(Change from baseline)

    Measured: 12 and 24 weeks

  4. Bolus insulin dose(Change from baseline)

    Bolus insulin dose(Change from baseline)

    Measured: 12 and 24 weeks

  5. Change in Total insulin dose(Change from baseline)

    Change in Total insulin dose(Change from baseline)

    Measured: 12 and 24 weeks

  6. Weight(Change from baseline)

    Weight(Change from baseline)

    Measured: 12 and 24 weeks

  7. Problem Areas in Diabetes score(Change from baseline)

    Problem Areas in Diabetes score(Change from baseline)

    Measured: 12 and 24 weeks

  8. Rate of hypoglycemic events (blood glucose level <70mg/dL)

    Rate of hypoglycemic events (blood glucose level <70mg/dL)

    Measured: 12 and 24 weeks

  9. Self-monitoring blood glucose frequency

    Self-monitoring blood glucose frequency

    Measured: 12 and 24 weeks

  10. Mean blood glucose concentration(Change from baseline)

    Mean blood glucose concentration(Change from baseline)

    Measured: 12 and 24 weeks

  11. Number of ER visits(Change from baseline)

    Number of ER visits(Change from baseline)

    Measured: 12 and 24 weeks

  12. Number of hospitalizations(Change from baseline)

    Number of hospitalizations(Change from baseline)

    Measured: 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2016 (estimated)
  2. Study start15 May 2017
  3. Primary completion17 Apr 2020
  4. Study completion17 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02974816
Sponsor's protocol ID
GL1
Status last verified
Jun 2021
First submitted
23 Nov 2016
Last updated
3 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 19940225

  • 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.

    PubMed 19017771

  • 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.

    PubMed 21788632

  • 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.

    PubMed 25537706

  • 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.

    PubMed 18474888

  • 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.

    PubMed 9135939

  • 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.

    PubMed 9732337

  • 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.

    PubMed 23468086

Questions about this trial

What is this clinical trial studying?

A study testing Glooko's mobile application in people with Diabetes Mellitus, Type 2, run by Glooko at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02974816, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.

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