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Behavioural Intervention

Intervention for Type 2 Diabetes (CRX-T2D Trial)

N/A
Waitlist Available
Led By Sujay Madduri, MD
Research Sponsored by QuiO
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 120
Awards & highlights

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.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 120
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 120 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HbA1c
Secondary study objectives
Fasting Blood Glucose
Mean Duration of Time to Reach Optimal Insulin Glargine Dose
Median Adherence to Insulin Glargine
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
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).
Group II: ControlActive Control1 Intervention
Subjects in the Control arm will receive the CRx Health solution for self-management of chronic conditions.

Find a Location

Who is running the clinical trial?

QuiOLead Sponsor
SHL MedicalUNKNOWN
MidMichigan HealthUNKNOWN
~19 spots leftby Sep 2025
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