Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    quio
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997331
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
SHL Medical
MidMichigan Health
Information provided by (Responsible Party):
QuiO

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: CRx Health Other: Chronicare Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Phase 1, Randomized Controlled Trial of the Chronicare Disease Management Program in Subjects With Type 2 Diabetes (Chronicare-T2D)
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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).

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.

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




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Day 0 - Day 120 ]
    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 :
  1. Fasting Blood Glucose [ Time Frame: Day 0 - Day 120 ]
    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

  2. Mean Duration of Time to Reach Optimal Insulin Glargine Dose [ Time Frame: Up to 120 days ]
    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.

  3. Proportion of Patients Reaching Optimal Insulin Glargine Dose [ Time Frame: Day 120 ]
    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.

  4. Median Adherence to Insulin Glargine [ Time Frame: Day 0 - Day 120 ]
    Insulin glargine adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window).

  5. Median Adherence to Metformin [ Time Frame: Day 0 - Day 120 ]
    Metformin adherence by treatment group (Intervention vs. Control), assessed by median adherence computed as percentage of doses taken on time (±2h dosing window).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997331


Contacts
Layout table for location contacts
Contact: Brenda Whitman, RN (989) 839-3018 cvresearch@midmichigan.org

Locations
Layout table for location information
United States, Michigan
Clinical Research Department
Midland, Michigan, United States, 48670
Contact: Brenda Whitman, RN    989-839-3018    brenda.whitman@midmichigan.org   
Principal Investigator: Sujay Madduri, MD         
Sponsors and Collaborators
QuiO
SHL Medical
MidMichigan Health
Investigators
Layout table for investigator information
Principal Investigator: Sujay Madduri, MD MidMichigan Health
Study Chair: Alexander Dahmani QuiO Technologies

Layout table for additonal information
Responsible Party: QuiO
ClinicalTrials.gov Identifier: NCT03997331    
Other Study ID Numbers: 1433742-2
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases