Continuous Glucose Monitoring (CGM) for Type 2 Diabetes

Health Partners Institute dba International Diabetes Center, Minneapolis, MN
Type 2 DiabetesContinuous Glucose Monitoring (CGM) - Device
Eligibility
18+
All Sexes

Study Summary

This trial looks at whether CGM or BGM help people with Type 2 diabetes keep their blood sugar in the right range.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Continuous Glucose Monitoring System
1
Continue Glucose Monitoring (CGM)
1
Eversense CGM System

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Three (3) months

Three (3) months
Ketones
Difference in Change in HbA1c
Difference in change in 14-day CGM-derived TIR
Difference in change in the CGM-derived metric, % Coefficient of variation, from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Mean amplitude of glucose excursion, from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Mean sensor glucose, from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Time above range > 180 mg/dL, from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Time above range > 250 mg/dL , from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Time below range <54 mg/dL , from Baseline to 3-month Post-Dietary Change period
Difference in change in the CGM-derived metric, Time below range <70 mg/dL , from Baseline to 3-month Post-Dietary Change period
Difference in percent of participants reaching CGM-derived consensus targets

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Continuous Glucose Monitoring System
1
Continue Glucose Monitoring (CGM)
1
Eversense CGM System

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Blood Glucose Monitoring (BGM)
1 of 2
Continuous Glucose Monitoring (CGM)
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Continuous Glucose Monitoring (CGM) · No Placebo Group · N/A

Continuous Glucose Monitoring (CGM)
Device
Experimental Group · 1 Intervention: Continuous Glucose Monitoring (CGM) · Intervention Types: Device
Blood Glucose Monitoring (BGM)NoIntervention Group · 1 Intervention: Blood Glucose Monitoring (BGM) · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Glucose Monitoring (CGM)
2009
N/A
~140

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: three (3) months

Who is running the clinical trial?

Abbott Diabetes CareIndustry Sponsor
58 Previous Clinical Trials
23,905 Total Patients Enrolled
HealthPartners InstituteLead Sponsor
173 Previous Clinical Trials
1,319,053 Total Patients Enrolled
Virta HealthIndustry Sponsor
4 Previous Clinical Trials
50,827 Total Patients Enrolled
Holly Willis, PhDPrincipal InvestigatorHealthPartners Institute dba International Diabetes Center

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You understand and can communicate effectively in English.
You agree to wear and use a special device called a CGM provided by the study for up to 7 months.
You are willing to follow a specific diet as part of the Virta Treatment for at least 7 months.
References

Frequently Asked Questions

What is the current enrollment rate for this trial?

"Affirmative, clinicaltrials.gov displays that this experiment is searching for participants. It was opened on the 22nd of September 2022 and was last amended on the 29th of September 2022. The study aims to enrol 150 patients at one site." - Anonymous Online Contributor

Unverified Answer

Are there any current opportunities for enrolment in this experiment?

"Affirmative. Clinicaltrials.gov specifies that this study is actively enrolling participants, with the initial posting of September 22nd 2022 and most recent update on September 29th 2022. The trial aims to sign up a total of 150 patients in one test site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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