Chronicare for Type 2 Diabetes (Chronicare-T2D)

NCT03997331 | Unknown

• 1 other identifier: 1433742-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fasting Blood Glucose

  Day 0 - Day 120

• Mean Duration of Time to Reach Optimal Insulin Glargine Dose

  Up to 120 days

• Proportion of Patients Reaching Optimal Insulin Glargine Dose

  Day 120

• Median Adherence to Insulin Glargine

  Day 0 - Day 120

• Median Adherence to Metformin

  Day 0 - Day 120

Study Arms (2)

Intervention

EXPERIMENTAL

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; Other: Chronicare

Control

ACTIVE COMPARATOR

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

Other: CRx Health

Interventions

CRx Health OTHER

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).

Control; Intervention

Chronicare OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• QuiO: lead
• SHL Medical: collaborator
• MidMichigan Health: collaborator

Study Sites (1)

Clinical Research Department

Midland, Michigan, 48670, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sujay Madduri, MD

  MidMichigan Health

  PRINCIPAL INVESTIGATOR

• Alexander Dahmani

  QuiO Technologies

  STUDY CHAIR

Central Study Contacts

Brenda Whitman, RN

CONTACT

(989) 839-3018; cvresearch@midmichigan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 25, 2019
• Study Start: May 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

US (1)