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CRx Remote Care Solution in Subjects With Type 2 Diabetes (CRX-T2D) (CRX-T2D)

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ClinicalTrials.gov Identifier: NCT03997331
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
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 CRx Remote Care Solution in the management of subjects with T2D who are being treated with insulin glargine and metformin. The CRx Remote Care Solution comprises connected devices (InsulCheck, a Bluetooth-enabled pill bottle cap, and a Bluetooth-enabled glucometer), a mobile smartphone app (CRx App), an automated support system (Intervention Engine), and a remote care application (Care Module).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Treated With Insulin Other: CRx Self-Management Solution Other: CRx Remote Care Solution Not Applicable

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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 CRx Remote Care Solution in Subjects With Type 2 Diabetes (CRX-T2D)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

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 Care Module) 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 Care Module. (Treatment Support Engine).
Other: CRx Self-Management Solution
The CRx Self-Management Solution comprises connected devices (InsulCheck, a Bluetooth-enabled pill bottle cap, and a Bluetooth-enabled glucometer), and a mobile smartphone app (CRx App).

Other: CRx Remote Care Solution
The CRx Remote Care Solution comprises an automated support system (Intervention Engine), and a remote care application (Care Module).

Active Comparator: Control
Subjects in the Control arm will not receive any notifications, in-app messages or contact from clinicians.
Other: CRx Self-Management Solution
The CRx Self-Management Solution comprises connected devices (InsulCheck, a Bluetooth-enabled pill bottle cap, and a Bluetooth-enabled glucometer), and a mobile smartphone app (CRx App).




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Day 0 - Day 90 ]
    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 90 ]
    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 90 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 90 ]
    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 90 ]
    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 90 ]
    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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects between 18 and 70 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 metformin 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 other agents affecting glycemic control other than insulin glargine and metformin.
  • 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).
  • 2 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
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Contact: Brenda Whitman, RN (989) 839-3018 cvresearch@midmichigan.org

Locations
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United States, Michigan
Clinical Research Department Not yet recruiting
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
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Principal Investigator: Sujay Madduri, MD MidMichigan Health
Study Chair: Alexander Dahmani QuiO Technologies

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Responsible Party: QuiO
ClinicalTrials.gov Identifier: NCT03997331     History of Changes
Other Study ID Numbers: 1433742-2
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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