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Personalized Dietary Management for Type 2 Diabetes (DiaTeleMed Trial)
N/A
Recruiting
Led By Mary Sevick, ScD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be an adult 21-80 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights
DiaTeleMed Trial Summary
This trial is testing whether a Standardized or Personalized treatment plan is better for early-stage T2D than the Usual Care Control.
Who is the study for?
Adults aged 21-80 with early-stage Type 2 Diabetes (T2D), HbA1c<8%, on a stable diabetes regimen including metformin, able to use a smartphone and attend online sessions. Excludes those with certain chronic diseases, unable or unwilling to follow the diet plan, pregnant women, those with limited mobility or control over their diet, substance abusers, and people on specific medications.Check my eligibility
What is being tested?
The trial is testing how effective personalized dietary guidance is at managing blood sugar after meals compared to standardized advice and usual care in people with T2D. It randomly assigns participants into three groups: Standardized Guidance Group, Personalized Guidance Group, or Usual Care Control Group.See study design
What are the potential side effects?
Since this trial focuses on dietary management rather than medication or invasive procedures, side effects are minimal but may include potential discomfort from changing eating habits such as digestive changes or food cravings.
DiaTeleMed Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 80 years old.
DiaTeleMed Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Amplitude of Glycemic Excursion (MAGE)
Secondary outcome measures
HbA1c Levels
DiaTeleMed Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care Control (UCC)Experimental Treatment1 Intervention
Baseline advice about the Mediterranean-style diet and attention control.
Group II: PersonalizedActive Control3 Interventions
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
Group III: StandardizedActive Control2 Interventions
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,380 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,306 Total Patients Enrolled
Mary Sevick, ScDPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have early-stage Type 2 Diabetes with HbA1c under 8%, managed with lifestyle changes and metformin for the past 3 months.You have limited control over what you eat, for example, if you are homeless, in a nursing home, or in jail.I have been diagnosed with a long-term inflammatory or cancerous disease in the last 3 years.I have not taken antibiotics, antifungals, certain diabetes drugs, weight loss drugs, steroids, immunosuppressants, atypical antipsychotics, or chemotherapy in the last 3 months.My health condition or treatment does not significantly affect my body's microbiome, insulin response, or ability to lose weight.I need a special diet due to kidney disease, cirrhosis, or HIV.I am unable or unwilling to give my consent for participation.You currently have a problem with using drugs or alcohol.I have had bariatric surgery or am not willing to wait 7 months for it.I have a long-term gut condition like Crohn's disease or celiac.I need a walker or cane to walk 2 city blocks.I am willing to accept any treatment group I am assigned to.I am between 21 and 80 years old.I have a chronic condition like Cushing's, acromegaly, or hyperthyroidism.I can use English software for self-monitoring without issues.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized
- Group 2: Usual Care Control (UCC)
- Group 3: Standardized
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to partake in this experimental research?
"To take part in this study, participants must have type 2 diabetes mellitus and be between 21-80 years of age. A total of 255 individuals are able to join the trial."
Answered by AI
Are there vacant positions for participants in this research?
"Affirmative. The listing of the trial on clinicaltrials.gov suggests that it is currently recruiting participants; this study was first launched on December 14th 2021 and has since been updated as recently as October 11th 2022. 255 individuals must be enrolled across a single medical centre."
Answered by AI
Does this research accept participants who have reached the age of retirement?
"Prospective participants in this medical trial must be between 21 and 80 years of age."
Answered by AI
How many volunteers have signed up for the trial?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was first posted on December 14th 2021, is actively recruiting patients. A total of 255 people will need to be enrolled from 1 separate medical centre."
Answered by AI
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