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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRx Health
Chronicare
Sponsored by
QuiO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Clinical Research Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Subjects in the Intervention arm will receive the following: 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). 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. 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). Push notifications that alert the subject that they have missed a scheduled regimen event. 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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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).
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).

Full Information

First Posted
June 20, 2019
Last Updated
March 29, 2020
Sponsor
QuiO
Collaborators
SHL Medical, MidMichigan Health
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1. Study Identification

Unique Protocol Identification Number
NCT03997331
Brief Title
Chronicare for Type 2 Diabetes (Chronicare-T2D)
Acronym
CRX-T2D
Official Title
A Phase 1, Randomized Controlled Trial of the Chronicare Disease Management Program in Subjects With Type 2 Diabetes (Chronicare-T2D)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QuiO
Collaborators
SHL Medical, MidMichigan Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects in the Intervention arm will receive the following: 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). 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. 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). Push notifications that alert the subject that they have missed a scheduled regimen event. 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).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects in the Control arm will receive the CRx Health solution for self-management of chronic conditions.
Intervention Type
Other
Intervention Name(s)
CRx Health
Intervention Description
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
Intervention Name(s)
Chronicare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
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.
Time Frame
Day 0 - Day 120
Secondary Outcome Measure Information:
Title
Fasting Blood Glucose
Description
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
Time Frame
Day 0 - Day 120
Title
Mean Duration of Time to Reach Optimal Insulin Glargine Dose
Description
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.
Time Frame
Up to 120 days
Title
Proportion of Patients Reaching Optimal Insulin Glargine Dose
Description
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.
Time Frame
Day 120
Title
Median Adherence to Insulin Glargine
Description
Insulin glargine adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window).
Time Frame
Day 0 - Day 120
Title
Median Adherence to Metformin
Description
Metformin adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window).
Time Frame
Day 0 - Day 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Whitman, RN
Phone
(989) 839-3018
Email
cvresearch@midmichigan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujay Madduri, MD
Organizational Affiliation
MidMichigan Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Dahmani
Organizational Affiliation
QuiO Technologies
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Research Department
City
Midland
State/Province
Michigan
ZIP/Postal Code
48670
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Whitman, RN
Phone
989-839-3018
Email
brenda.whitman@midmichigan.org
First Name & Middle Initial & Last Name & Degree
Sujay Madduri, MD

12. IPD Sharing Statement

Learn more about this trial

Chronicare for Type 2 Diabetes (Chronicare-T2D)

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