All > Diabetes Type 2

MTM for Type 2 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of North Carolina at Chapel Hill, Chapel Hill, NCType 2 DiabetesMTM - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test the efficacy of a medically tailored meal intervention for adults with food insecurity and Type 2 Diabetes Mellitus.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Medically Tailored Meals
1
Glycemic Control Financial Incentive
1
Nutritional Counseling and education

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: 12 months

12 months
ARMS-D Medication Adherence Score at Month 12
Bodyweight at Month 12
Care Delay at Month 12
Cost-Related Medication Underuse at Month 12
Depressive Symptom Score at Month 12
Diabetes Distress Score as assessed by PAID-11 at Month 12
Diabetes Self-Care Activities Medication Adherence Score at Month 12
Diastolic Blood Pressure at Month 12
Diet Quality Score at Month 12
Diet Self-Efficacy Score at Month 12
Financial Strain
Food Insecurity Score at Month 12
Food/Medication Trade-offs at Month 12
Frequency of self-reported hypoglycemia at Month 12
Frequency of self-reported severe hypoglycemia at Month 12
Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12
Hemoglobin A1c at Month 12
Housing Insecurity Score at Month 12
Perceived Diabetes Self-Management Self-Efficacy Score at Month 12
Stress Score at 12 months
Systolic Blood Pressure at Month 12
Transportation Barriers at Month 12
6 months
ARMS-D (Adherence to Refills and Medications Scale-Diabetes) Medication Adherence Score at Month 6
Bodyweight at Month 6
Care Delay at Month 6
Cost-Related Medication Underuse at Month 6
Depressive Symptom Score at Month 6
Diabetes Distress Score as assessed by PAID (Problem Areas in Diabetes)-11 at Month 6
Diabetes Self-Care Activities Medication Adherence Score at Month 6
Diastolic Blood Pressure at Month 6
Diet Quality Score at Month 6
Diet Self-Efficacy Score at Month 6
Food Insecurity Score at Month 6
Food/Medication Trade-offs at Month 6
Frequency of self-reported hypoglycemia at Month 6
Frequency of self-reported severe hypoglycemia at Month 6
Health-Related Quality of Life Score as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System)-29 at Month 6
Hemoglobin A1c at Month 6
Housing Insecurity at Month 6
Perceived Diabetes Self-Management Self-Efficacy Score at Month 6
Stress Score at 6 months
Systolic Blood Pressure at Month 6
Transportation Barriers at Month 6

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Medically Tailored Meals
1
Glycemic Control Financial Incentive
1
Nutritional Counseling and education

Trial Design

2 Treatment Groups

Food Subsidy
1 of 2
Medically Tailored Meal (MTM)
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: MTM · No Placebo Group · N/A

Medically Tailored Meal (MTM)
Other
Experimental Group · 1 Intervention: MTM · Intervention Types: Other
Food Subsidy
Other
ActiveComparator Group · 1 Intervention: Food Subsidy · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,384 Previous Clinical Trials
3,938,080 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,730 Previous Clinical Trials
31,213,524 Total Patients Enrolled
Community ServingsUNKNOWN
2 Previous Clinical Trials
216 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,185 Previous Clinical Trials
4,089,629 Total Patients Enrolled
Seth Berkowitz, MDPrincipal InvestigatorUNC

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can choose what you eat and have control over your diet.
References

Frequently Asked Questions

How many subjects are subjecting themselves to this research?

"Indeed, the information on clinicaltrials.gov attests to this trial's current recruitment phase. Initially published on July 2nd 2021 and most recently updated August 9th 2022, 200 potential subjects are being sought from a single site." - Anonymous Online Contributor

Unverified Answer

Can subjects currently enroll in this research endeavor?

"The clinical trial is in the recruitment phase, as per information provided on clinicaltrials.gov. It was initially posted on July 2nd 2021 and most recently updated on August 9th 2022." - 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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