Chronicare for Type 2 Diabetes (Chronicare-T2D)

Type 2 Diabetes Clinical Trial

— CRX-T2D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03997331
• Other study ID #: 1433742-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: February 2021

Study information

• Verified date: March 2020
• Source: QuiO
• Contact: Brenda Whitman, RN
• Phone: (989) 839-3018
• Email: cvresearch[@]midmichigan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 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).
• 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.

Locations

Country	Name	City	State
United States	Clinical Research Department	Midland	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
QuiO	MidMichigan Health, SHL Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 - Day 120
Secondary	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	Day 0 - Day 120
Secondary	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.	Up to 120 days
Secondary	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.	Day 120
Secondary	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).	Day 0 - Day 120
Secondary	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).	Day 0 - Day 120