Chronicare for Type 2 Diabetes (Chronicare-T2D)

NCT ID: NCT03997331

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2021-02-28

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention

Subjects 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).

Group Type: EXPERIMENTAL

CRx Health

Intervention Type: OTHER

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).

Chronicare

Intervention Type: OTHER

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.

Control

Subjects in the Control arm will receive the CRx Health solution for self-management of chronic conditions.

Group Type: ACTIVE_COMPARATOR

CRx Health

Intervention Type: OTHER

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).

Interventions

CRx Health

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).

Intervention Type: OTHER

Chronicare

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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.

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SHL Medical

UNKNOWN

Sponsor Role: collaborator

MidMichigan Health

UNKNOWN

Sponsor Role: collaborator

QuiO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sujay Madduri, MD

Role: PRINCIPAL_INVESTIGATOR

MidMichigan Health

Alexander Dahmani

Role: STUDY_CHAIR

QuiO Technologies

Locations

Clinical Research Department

Midland, Michigan, United States

Countries

United States

Central Contacts

Brenda Whitman, RN

Role: CONTACT

cvresearch@midmichigan.org

(989) 839-3018

Facility Contacts

Brenda Whitman, RN

Role: primary

brenda.whitman@midmichigan.org

989-839-3018

Other Identifiers

1433742-2

Identifier Type: -

Identifier Source: org_study_id