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CGM-Based Insulin Titration for Type 2 Diabetes (CGM-DTx Trial)

N/A

Recruiting

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On daily basal insulin for at least 90 days before inclusion into the study

Age 18 years or older at signing of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)

Awards & highlights

CGM-DTx Trial Summary

This trial will compare two treatments for T2D to see which is better at controlling blood sugar: CGM-based and self-monitoring w/insulin. Participants will be followed for 18 weeks.

Who is the study for?

Adults over 18 with Type 2 Diabetes, on long-acting insulin for at least 90 days, and an A1c level between 7-9%. They must be stable on certain diabetes medications but cannot use short-acting insulin or have used a CGM recently. Pregnant women or those not using contraception are excluded.Check my eligibility

What is being tested?

The trial is testing if a new way to adjust basal insulin doses using continuous glucose monitoring (CGM) is better than the standard method of self-monitoring blood glucose levels in managing blood sugar over an 18-week period.See study design

What are the potential side effects?

Potential side effects may include skin reactions to CGM adhesives and risks typically associated with adjusting insulin dosages such as low blood sugar episodes.

CGM-DTx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been using daily insulin injections for at least 3 months.

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I am 18 years old or older.

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My diabetes medication dose has been stable for the last 90 days.

CGM-DTx Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (-2 to 0 weeks) to weeks 14-16 (2 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Time in Range

Secondary outcome measures

Change in Continuous Glucose Monitoring Coefficient of variation (%)

Change in HbA1c

Change in Mean Glucose Level

+11 more

CGM-DTx Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Continuous Glucose Monitoring (CGM) based TitrationExperimental Treatment1 Intervention

The CGM-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. For dose computation the algorithm is comprised of three components; titration glucose level, personalized target, and safety hypoglycemia feature.

Group II: Standard Self-Monitoring Blood Glucose (SMBG) TitrationActive Control1 Intervention

The SMBG-based titration algorithm will run on the Diabetes Assistant and Amazon Web Services (AWS) platform (DiAs-Cloud). DiAs-Cloud enables the seamless integration of a smart phone application and AWS server architecture to enable data capture, dose computation, review by the clinical team, and communication to study participants. Participants in the standard SMBG based titration group will wear a blinded CGM during the whole study. The total daily basal insulin dose will be converted 1:1 to Degludec. Algorithm informed dose changes will be made once weekly and checked by study physician.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Novo Nordisk A/SIndustry Sponsor

1,514 Previous Clinical Trials

2,415,038 Total Patients Enrolled

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,245,043 Total Patients Enrolled

Ralf M Nass, MDStudy ChairUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still available for participants wanting to join this experiment?

"This research study, which was initially listed on November 30th 2023 and last revised October 26th of the same year, is not currently looking for participants. Nonetheless, 874 other clinical trials are open to enrollment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.

Marc Breton 2023. "The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111508.