Type2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Hyperglycemia, Personal Nutrition Project
Brief summary
This is an initial validation study of the Personal Nutrition Project (PNP) algorithm in a North American population with recently diagnosed Type 2 Diabetes (T2D). This is a 2-stage, single-group feeding study in 20 individuals, including 10 participants managed with lifestyle alone, and 10 managed with lifestyle plus metformin.
Detailed description
The PNP algorithm, which uses a machine learning algorithm to predict postprandial glycemic, may be efficacious for generating tailored dietary advice to moderate the participant's glycemic response to food.
Interventions
A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.
BEHAVIORALLifeStyle
Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Investigators will recruit approximately 5 cohorts of 4 participants each for the sample size of 20 participants. A new cohort will be randomized approximately every 4 weeks. The maximum number of study participants at any point in the study will be 10.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age \>21 years to \<70 years * Diagnosed with T2DM within 2 years with an HbA1c\<7% * Diabetes management by metformin or lifestyle intervention * Fasting C-peptide ≥ 0.5 mg/mL (0.17 nmol/L) (to exclude those for whom hyperglycemic exposure is driven by β-cell failure rather than dietary behaviors, as well as those requiring escalation of the medication regime) * Ownership a smart phone and are willing to use it to monitor multiple factors influencing glycemic response to glycemia (e.g., sleep, physical activity, diet, stress, medication, and hunger)
Exclusion criteria
* are unable or unwilling to provide informed consent; * are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia); * are pregnant, are currently trying to become pregnant, or who become pregnant during the study * are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over self-management) * have had or are planning to have bariatric surgery during the study * have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D) * those with an active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study; * those who use acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects CGM accuracy)39 * immunosuppressive drugs within three months prior to participation and * Chronically active inflammatory or neoplastic disease in the three years prior to enrollment. * Patients with known food allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Incremental Area Under the Curve (iAUCobs) | 2 Hours | Observed incremental area under the curve (iAUCobs) at 2 hours following each meal and snack will be evaluated via CGM using the Abbott Freestyle Libre Pro, which captures interstitial glucose every 5 minutes. A sensor is inserted into the participant's upper arm. Participants will be blinded to glycemia tracings. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Life Style + Metformin Abbott Freestyle Libre Pro: A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.
LifeStyle: Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 5 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Life Style + Metformin |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Observed Incremental Area Under the Curve (iAUCobs)
Observed incremental area under the curve (iAUCobs) at 2 hours following each meal and snack will be evaluated via CGM using the Abbott Freestyle Libre Pro, which captures interstitial glucose every 5 minutes. A sensor is inserted into the participant's upper arm. Participants will be blinded to glycemia tracings.
Time frame: 2 Hours
Population: There is not enough usable data collected to analyze primary outcome measure due to low adherence to the study.