AzTrials
AzTrials

Type 2 DiabetesCRX-T2DNCT03997331

Chronicare for Type 2 Diabetes (Chronicare-T2D)

A study testing CRx Health and Chronicare in people with Type 2 Diabetes, run by QuiO at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the Chronicare Disease Management Program in the management of subjects with T2D who are being treated with insulin glargine and metformin. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
CRx Health and Chronicare
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
May 2020to Feb 2021
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

  • Male and female subjects between 18 and 75 years of age, inclusive, at Screening.
  • Diagnosed with T2D
  • Have a baseline HbA1c level between 7.5% and 10.0%, inclusive, while receiving insulin glargine and metformin.
  • Prescribed insulin glargine and an oral diabetes medication for ≥ 6 months prior to Screening.
  • The ability to follow an evening dosing schedule for insulin glargine.
  • Have an eGFR level >30 L/min, inclusive, according to their most recent measurement.
Show all 9Show fewer
  • If female, must be post-menopausal or surgically sterile, or be established on (≥ 3 months prior to Screening) and agree to continue to use the same highly effective method of birth control throughout the study. Females must agree to avoid pregnancy during their participation in the study.
  • Able to comprehend and give informed consent.
  • Able to comply with the requirements of the study, which include being able to speak and read English, and to complete the full sequence of protocol-related procedures.

Who cannot join

  • Females who are pregnant (positive pregnancy test at Screening), lactating, or if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice.
  • Have type 1 diabetes.
  • Have had or have a malignant neoplasm within the past five years.
  • Undergoing chronic or recurrent treatment with systemic corticosteroids or niacin treatment for hyperlipidemia.
  • Use of one or more of the following agents affecting glycemic control:
  • mifepristone, GLP-1RA, or any insulin other than insulin glargine.
Show all 12Show fewer
  • Concurrent treatment with experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half-lives, whichever is greater, prior to study start.
  • Unable or unwilling to follow the evening insulin glargine regimen required by the titration protocol (once daily dose must be scheduled between 5pm and 12am).
  • Blood transfusions or severe blood loss in the last 3 months.
  • Any other unspecified reason that, in the opinion of the Investigator (or designee) or Sponsor, makes the subject unsuitable for enrollment.
  • Active diagnosis of hypoglycemic unawareness.
  • Hypoglycemia (blood glucose <70 mg/dl with or without symptoms) greater than one episode per week (on average)

Trial locations and contacts

1 site in 1 country.

Brenda Whitman, RN contact

(989) 839-3018

cvresearch@midmichigan.org

United States1 site

  • Clinical Research Department

    Midland, Michigan, 48670

    Brenda Whitman, RN, 989-839-3018, brenda.whitman@midmichigan.org

    Sujay Madduri, MD

Other trials in United States

About this study

Official title: A Phase 1, Randomized Controlled Trial of the Chronicare Disease Management Program in Subjects With Type 2 Diabetes (Chronicare-T2D)

This single-blind, single-center, randomized, controlled trial is designed to evaluate the utility of the Chronicare Disease Management Program in the management of subjects with T2D who are being treated with insulin glargine and metformin. The Chronicare Solution comprises connected devices (a Bluetooth-enabled insulin pen sensor, a Bluetooth-enabled medication container, and a Bluetooth-enabled glucometer), a mobile smartphone app (CRx Health), an automated support system (Intervention Engine), and a remote care application (CRx Care) used by a team of clinicians to monitor and support patients.

Conditions
Type 2 Diabetes
Being tested
CRx Health, Chronicare
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.

  • CRx HealthOther

    CRx Health is a connected health solution comprised of connected devices (InsulCheck, a Bluetooth-enabled pill bottle cap, and a Bluetooth-enabled glucometer) paired to a mobile smartphone app (CRx Health).

  • ChronicareOther

    Chronicare is a disease management program comprising self-management data from the CRx Health solution syncing to an automated support system (Intervention Engine) and a remote care application (CRx Care) used by a team of clinicians to remotely monitor and support patients.

Study groups in NCT03997331
Study groupRoleWhat they receive
InterventionExperimentalSubjects in the Intervention arm will receive the following: 1. Automated in-app messages containing behavioral and educational content that is tailored to each subject based on an assessment of their entry survey results and on their adherence and glucose data. (Behavioral Support Engine). 2. Targeted in-app messages and phone calls from clinicians or as designated by the Investigator (through the CRx Care app) based on the subject's adherence and glucose data. 3. Push notifications that alert the subject that it is time to complete a regimen event (ie take medication or take a fasting blood glucose reading). 4. Push notifications that alert the subject that they have missed a scheduled regimen event. 5. In-app messages containing adjustments to the subject's insulin glargine dose when the Investigator(s) approves an adjustment in the CRx Care App. (Treatment Support Engine).
Receives: Other: CRx Health; Other: Chronicare
ControlActive comparatorSubjects in the Control arm will receive the CRx Health solution for self-management of chronic conditions.
Receives: Other: CRx Health

What is being measured

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

  1. Change in HbA1c

    The primary endpoint is the difference in the reduction in HbA1c for each subject by treatment group (Intervention vs. Control), assessed by the mean reduction across all subjects in each treatment group.

    Measured: Day 0 - Day 120

Secondary outcomes (5)

  1. Fasting Blood Glucose

    Fasting blood glucose level (Intervention vs. Control), measured by the proportion of measurements of self-reported fasting blood glucose within the range of 70-110 mg/dL for subjects in each study arm

    Measured: Day 0 - Day 120

  2. Mean Duration of Time to Reach Optimal Insulin Glargine Dose

    Optimal insulin glargine dose (Intervention vs. Control), measured by the mean duration of time elapsed prior to reaching a mean self-reported fasting blood glucose value of 70-110 mg/dL over a 7-day period.

    Measured: Up to 120 days

  3. Proportion of Patients Reaching Optimal Insulin Glargine Dose

    Optimal insulin glargine dose (Intervention vs. Control), measured by the proportion of patients reaching a mean self-reported fasting blood glucose value of 70-110 mg/dL over a 7-day period.

    Measured: Day 120

  4. Median Adherence to Insulin Glargine

    Insulin glargine adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window).

    Measured: Day 0 - Day 120

  5. Median Adherence to Metformin

    Metformin adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window).

    Measured: Day 0 - Day 120

Timeline

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

  1. First posted25 Jun 2019
  2. Study startMay 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionFeb 2021 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03997331
Sponsor's protocol ID
1433742-2
Acronym
CRX-T2D
Status last verified
Mar 2020
First submitted
20 Jun 2019
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CRx Health and Chronicare in people with Type 2 Diabetes, run by QuiO at 1 site 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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Brenda Whitman, RN ((989) 839-3018, cvresearch@midmichigan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: Day 0 - Day 120). 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 NCT03997331.

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 31 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in