Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes

Glycated hemoglobin

Time in range is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Time in Range is defined as the % of time each day with a glucose measure between 70-180 mg/dl. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.

Glycemic variability is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Glycemic variability is defined as the Standard Deviation (SD) of the mean glucose during the wear period. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.

A measure of the mean, 24 hour glucose concentration calculated across all recorded glucose readings during the wear period

Standard (mg/dl) measure taken fasting (morning) during baseline, 12 weeks, 24 weeks

Standard lab measurement for fasting insulin assessment

Fructosamine (umol/L) represents usual glycemia over the past 2-3 weeks, and is considered a valid marker of short term clinical glycemic patterns by the American Diabetes Association

Weight measured on standardized scale in gown

Total cholesterol was measured as part of a lipid panel, a standard measurement for assessing clinical CVD risk

eGFR-Cystatin-C (estimated glomerular filtration rate) = mL/min/1.73 m^2

Systolic blood pressure (mmHg)

Standard part of blood pressure measurement (mmHG)

Apo-AI the major protein component of high density lipoprotein (HDL)

ApoB levels indicate the atherogenic particle concentration independent of the particle cholesterol content

A protein involved in forming blood clots in the body

biomarker of inflammation

AST (aspartate aminotransferase) is an enzyme that reflects liver function

ALT (alanine transaminase) is an enzyme, a protein that reflects liver function

ALP is an enzyme, a protein, that reflects liver function

Hormone measured in the blood with energy balance related role

The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations and dietary patterns published in the Dietary Guidelines for Americans (Dietary Guidelines). The overall HEI scores are made up of 13 components that reflect the different food groups and key recommendations in the Dietary Guidelines for Americans. The HEI is scored 0-100 (low to high), with higher scores representing greater reported intake of an overall dietary pattern aligning with USDA Dietary Guidelines. In the SODAS study, dietary intake was assessed by multiple unannounced 24-hour dietary recalls that occurred during the 2-week run-in period to assess usual habits (2 recalls over 2 weeks) and the active intervention (5 recalls over 24 weeks: 2 to 3 recalls during weeks 1-12 (period 1), and 2 to 3 recalls during weeks 13-24 (period 2). to measure any changes in diet quality. Scores during each period represent the average score of recalls.

The Diabetes Health Profile (DHP-18) is used to assess health related quality of life in diabetes across three domains (psychological distress, barriers to activity and disinhibited eating). Each item is scored on a 4-point scale, and the subscale scores are then rescaled to a 0-100 range, with higher scores indicating poorer well-being.

The FCI is a valid and reliable self-report measure of specific food cravings. The inventory consists of 4 factors or subscales measuring cravings for high fats (8 items), carbohydrates/starches (8 items), sweets (8 items), and fast food fats (4 items), and a total score is calculated by summing the subscales. Participants rate each food on a 5-point Likert scale ranging from 0 (never) to 4 (always/almost every day). We calculated the total score by summing the individual item responses in each subscale. Higher scores indicate more frequent cravings of the 28 items.

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties

The medication effect score (MES) is a measure of overall diabetes regimen intensity, and is based on the dosages of medications used and their potencies. The MES is calculated for each diabetes medication in a regimen using the following equation: (actual drug dose/maximum drug dose) × drug-specific adjustment factor. The adjustment factor equates to the expected decrease in HbA1c achieved by the drug as monotherapy. The MES presumes a linear relationship between medication dosage and HbA1c, and the sum of MES values attributed to individual medications represents the maximum A1c reduction that may be expected by the regimen. It is a continuous variable with range 0 (no medications), and the maximum achievable MES is patient specific and dependent on the total number of and dose of medications reported.

The therapeutic intensity score (TIS) is a summary measure that accounts for the number of medications and the relative doses a patient received to lower blood pressure. It is a continuous variable with range 0 (no medications), and the maximum achievable TIS is patient specific and dependent on the total number of antihypertensive medications reported.