Chronicare for Type 2 Diabetes (Chronicare-T2D) (CRX-T2D)

QuiO

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Other: Chronicare; Other: CRx Health

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03997331

1433742-2

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention

Experimental group

Description:

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).

Treatment:

Other: CRx Health

Other: Chronicare

Control

Active Comparator group

Description:

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

Treatment:

Other: CRx Health