- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03997331
Chronicare for Type 2 Diabetes (Chronicare-T2D) (CRX-T2D)
March 29, 2020 updated by: QuiO
A Phase 1, Randomized Controlled Trial of the Chronicare Disease Management Program in Subjects With Type 2 Diabetes (Chronicare-T2D)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brenda Whitman, RN
- Phone Number: (989) 839-3018
- Email: cvresearch@midmichigan.org
Study Locations
-
-
Michigan
-
Midland, Michigan, United States, 48670
- Clinical Research Department
-
Contact:
- Brenda Whitman, RN
- Phone Number: 989-839-3018
- Email: brenda.whitman@midmichigan.org
-
Principal Investigator:
- Sujay Madduri, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Subjects in the Intervention arm will receive the following:
|
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 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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 0 - Day 120
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0 - Day 120
|
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.
|
Up to 120 days
|
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.
|
Day 120
|
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).
|
Day 0 - Day 120
|
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).
|
Day 0 - Day 120
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sujay Madduri, MD, MidMichigan Health
- Study Chair: Alexander Dahmani, QuiO Technologies
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
May 1, 2020
Primary Completion (ANTICIPATED)
December 1, 2020
Study Completion (ANTICIPATED)
February 1, 2021
Study Registration Dates
First Submitted
June 20, 2019
First Submitted That Met QC Criteria
June 24, 2019
First Posted (ACTUAL)
June 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 29, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1433742-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on CRx Health
-
Sonoma Orthopedic Products, Inc.TerminatedFracture of ClavicleUnited States
-
University of ChicagoNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
University of ChicagoNational Institute on Aging (NIA)Enrolling by invitation
-
Ann & Robert H Lurie Children's Hospital of ChicagoPatient-Centered Outcomes Research Institute; University of Chicago; Missing...Recruiting
-
IRCCS Policlinico S. MatteoUnknownDiverticular Disease | Symptomatic Uncomplicated Diverticular DiseaseItaly
-
ZalicusTerminatedKnee OsteoarthritisUnited States, Canada
-
Florida State UniversityUniversity of North Carolina, Chapel Hill; University of GeorgiaEnrolling by invitationCardiovascular Disease Risk ReductionUnited States
-
Universiti Putra MalaysiaRecruitingNeck Pain | Cervical Spondylosis | Neck DisorderChina
-
University of WashingtonNational Institute on Aging (NIA)RecruitingOsteo Arthritis KneeUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI)CompletedCervical Cancer | Breast CancerUnited States