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Behavioural Intervention

Personalized Nutrition Therapy for Type 2 Diabetes

N/A
Recruiting
Led By Anne Bantle, MD,MS
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a previous diagnosis of type 2 diabetes
At least 18 years of age
Must not have
Type 1 diabetes
Treatment with insulin, sulfonylurea, or meglitinide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

This trial aims to test the use of continuous glucose monitoring (CGM) to personalize nutrition therapy for individuals with type 2 diabetes who are not meeting their blood sugar goals. Current nutrition plans often do

Who is the study for?
This trial is for individuals with Type 2 Diabetes who are not currently meeting their blood sugar control goals. It's designed to see if personalized nutrition advice using continuous glucose monitoring (CGM) helps better than standard nutrition therapy alone.
What is being tested?
Participants will either receive a combination of CGM and tailored nutrition therapy or just the standard nutrition guidance without CGM. The goal is to determine if real-time blood sugar tracking can improve dietary plans and diabetes outcomes.
What are the potential side effects?
While the study itself may not have direct side effects, participants should be aware that using CGM involves frequent skin contact with a device, which could cause irritation or discomfort at the site of attachment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with type 2 diabetes.
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I am 18 years old or older.
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My diabetes medication has been stable for 3 months and I don't plan to change it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Type 1 diabetes.
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I am being treated with insulin or certain diabetes medications.
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My kidney function is reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Glucose variability/coefficient of variation
mean glucose
time above range (glucose 70-180 mg/dl)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group1Experimental Treatment1 Intervention
After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to unblinded CGM plus nutrition therapy
Group II: Group 2Active Control1 Intervention
After consent, screening, and a 10-day run-in period, eligible participants will be randomly assigned to nutrition therapy only

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Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,413 Previous Clinical Trials
1,561,393 Total Patients Enrolled
Anne Bantle, MD,MSPrincipal InvestigatorUniversity of Minnesota
~6 spots leftby Jul 2025
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