Glooko mHealth Advantage Study

June 2, 2021 updated by: Glooko

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network Clinical Research Center
      • Elk Grove, California, United States, 95758
        • Sutter Health
      • San Diego, California, United States, 92121
        • Scripps Whittier Diabetes Institute
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Standard of Care
Subjects in this arm will visit their physician once every 3 months and will receive usual care.
EXPERIMENTAL: Remote Monitoring
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
Standard of care and Remote monitoring
Other Names:
  • Glooko's Population Tracker, Meter Sync Blue

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline
Time Frame: 24 weeks
Change in HbA1c from baseline
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline
Time Frame: 12 weeks
Change in HbA1c from baseline
12 weeks
Percentage of patients achieving </=7%
Time Frame: 12 and 24 weeks
Percentage of patients achieving </=7%
12 and 24 weeks
Basal insulin dose(Change from baseline)
Time Frame: 12 and 24 weeks
Basal insulin dose(Change from baseline)
12 and 24 weeks
Bolus insulin dose(Change from baseline)
Time Frame: 12 and 24 weeks
Bolus insulin dose(Change from baseline)
12 and 24 weeks
Change in Total insulin dose(Change from baseline)
Time Frame: 12 and 24 weeks
Change in Total insulin dose(Change from baseline)
12 and 24 weeks
Weight(Change from baseline)
Time Frame: 12 and 24 weeks
Weight(Change from baseline)
12 and 24 weeks
Problem Areas in Diabetes score(Change from baseline)
Time Frame: 12 and 24 weeks
Problem Areas in Diabetes score(Change from baseline)
12 and 24 weeks
Rate of hypoglycemic events (blood glucose level <70mg/dL)
Time Frame: 12 and 24 weeks
Rate of hypoglycemic events (blood glucose level <70mg/dL)
12 and 24 weeks
Self-monitoring blood glucose frequency
Time Frame: 12 and 24 weeks
Self-monitoring blood glucose frequency
12 and 24 weeks
Mean blood glucose concentration(Change from baseline)
Time Frame: 12 and 24 weeks
Mean blood glucose concentration(Change from baseline)
12 and 24 weeks
Number of ER visits(Change from baseline)
Time Frame: 12 and 24 weeks
Number of ER visits(Change from baseline)
12 and 24 weeks
Number of hospitalizations(Change from baseline)
Time Frame: 12 and 24 weeks
Number of hospitalizations(Change from baseline)
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glooko

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GL1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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