Type 2 Diabetes Mellitus Clinical Trial
Official title:
Fresh Carts for Mom's to Improve Food Security and Glucose Management
NCT number | NCT05979519 |
Other study ID # | 86500 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 26, 2023 |
Est. completion date | April 28, 2024 |
Verified date | June 2024 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery prescription with delivery through Instacart at the start of the study or after 12 weeks or frozen medically tailored meals delivered from Door Dash. Researchers will compare the grocery prescription program, MTM (medically tailored meals), relative to standard of care to see if the impact on these food as medicine programs can improve glucose control over 12-weeks as compared to standard of care.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 28, 2024 |
Est. primary completion date | April 28, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - diagnosis of gestational diabetes or type 2 diabetes - answer affirmative to one of two questions on the Hunger Vital Signs - viable pregnancy - lives in a service area of Instacart delivery - has a phone or computer which allows ordering food for delivery Exclusion Criteria: - Does not speak English - Does not have a phone, tablet, or computer to order groceries for Instacart - Plans to move within the next 3 months |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
United States | U of L Health | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Alison Gustafson | Instacart Health, Kentucky Association of Health Plans |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage Change in fasting blood glucose | Fasting blood glucose obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart. | baseline and post intervention, approximately 12 weeks | |
Secondary | Change in food insecurity | The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity. | baseline and post intervention, approximately 12 weeks | |
Secondary | Change in self efficacy | The self efficacy scale for diabetes measures the confidence in managing diabetes. Scores range from 1 to 10 with a higher score indicating greater confidence in managing diabetes. | baseline and post intervention, approximately 12 weeks | |
Secondary | Change in blood pressure | Diastolic and systolic Blood pressure will be obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart. | baseline and post intervention, approximately 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
Completed |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|
||
Completed |
NCT02226003 -
Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
|
Phase 3 |