Trial Outcomes & Findings for ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development) (NCT NCT03651622)

NCT ID: NCT03651622

Last Updated: 2022-03-04

Results Overview

Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit
• Results posted on: 2022-03-04

Participant Flow

Participant milestones

Measure	Hypocaloric, Low Carbohydrate Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. Hypocaloric, low carbohydrate diet: Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.	Hypocaloric, Moderate Low Fat Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. Hypocaloric, moderate low fat diet: Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.	Mediterranean, no Caloric Restriction Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. Mediterranean diet, no caloric restriction: Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Diet Period 1 (Randomization 1) STARTED	23	24	21
Diet Period 1 (Randomization 1) COMPLETED	19	17	12
Diet Period 1 (Randomization 1) NOT COMPLETED	4	7	9
Diet Period 2 (Randomization 2) STARTED	19	15	14
Diet Period 2 (Randomization 2) Number of Participants Rerandomized From Hypocaloric, Low Carbohydrate Diet	0	5	5
Diet Period 2 (Randomization 2) Number of Participants Rerandomized From Hypocaloric, Moderate Low Fat Diet	5	0	6
Diet Period 2 (Randomization 2) Number of Participants Rerandomized From Mediterranean, no Caloric Restriction Diet	5	4	0
Diet Period 2 (Randomization 2) Number of Participants Not Rerandomized	9	6	3
Diet Period 2 (Randomization 2) COMPLETED	17	13	11
Diet Period 2 (Randomization 2) NOT COMPLETED	2	2	3
Diet Period 3 (Randomization 3) STARTED	14	9	18
Diet Period 3 (Randomization 3) Number of Participants Rerandomized From Hypocaloric, Low Carbohydrate Diet	0	2	10
Diet Period 3 (Randomization 3) Number of Participants Rerandomized From Hypocaloric, Moderate Low Fat Diet	4	0	6
Diet Period 3 (Randomization 3) Number of Participants Rerandomized From Mediterranean	6	4	0
Diet Period 3 (Randomization 3) Number of Participants Not Rerandomized	4	3	2
Diet Period 3 (Randomization 3) COMPLETED	14	9	17
Diet Period 3 (Randomization 3) NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	Hypocaloric, Low Carbohydrate Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. Hypocaloric, low carbohydrate diet: Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.	Hypocaloric, Moderate Low Fat Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. Hypocaloric, moderate low fat diet: Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.	Mediterranean, no Caloric Restriction Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized. Mediterranean diet, no caloric restriction: Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
Diet Period 1 (Randomization 1) Lost to Follow-up	0	6	2
Diet Period 1 (Randomization 1) Withdrawal by Subject	4	1	7
Diet Period 2 (Randomization 2) Lost to Follow-up	0	2	3
Diet Period 2 (Randomization 2) Withdrawal by Subject	2	0	0
Diet Period 3 (Randomization 3) Withdrawal by Subject	0	0	1

Baseline Characteristics

N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.

Baseline characteristics by cohort

Measure	Hypocaloric, Low Carbohydrate n=23 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=24 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=21 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Total n=68 Participants Total of all reporting groups
Age, Continuous	25.5 years STANDARD_DEVIATION 3.3 • n=23 Participants	24.9 years STANDARD_DEVIATION 2.8 • n=24 Participants	26.1 years STANDARD_DEVIATION 3.2 • n=21 Participants	25.5 years STANDARD_DEVIATION 3.1 • n=68 Participants
Sex: Female, Male Female	15 Participants n=23 Participants	14 Participants n=24 Participants	20 Participants n=21 Participants	49 Participants n=68 Participants
Sex: Female, Male Male	8 Participants n=23 Participants	10 Participants n=24 Participants	1 Participants n=21 Participants	19 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=23 Participants	5 Participants n=24 Participants	4 Participants n=21 Participants	11 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=23 Participants	19 Participants n=24 Participants	17 Participants n=21 Participants	57 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=23 Participants	0 Participants n=24 Participants	0 Participants n=21 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Asian	1 Participants n=23 Participants	1 Participants n=24 Participants	0 Participants n=21 Participants	2 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=23 Participants	1 Participants n=24 Participants	0 Participants n=21 Participants	1 Participants n=68 Participants
Race (NIH/OMB) Black or African American	3 Participants n=23 Participants	1 Participants n=24 Participants	2 Participants n=21 Participants	6 Participants n=68 Participants
Race (NIH/OMB) White	17 Participants n=23 Participants	19 Participants n=24 Participants	13 Participants n=21 Participants	49 Participants n=68 Participants
Race (NIH/OMB) More than one race	1 Participants n=23 Participants	1 Participants n=24 Participants	4 Participants n=21 Participants	6 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=23 Participants	1 Participants n=24 Participants	2 Participants n=21 Participants	4 Participants n=68 Participants
Region of Enrollment United States	23 Participants n=23 Participants	24 Participants n=24 Participants	21 Participants n=21 Participants	68 Participants n=68 Participants
Weight (kg)	86.2 kilograms STANDARD_DEVIATION 10.7 • n=23 Participants	91.9 kilograms STANDARD_DEVIATION 15.4 • n=24 Participants	90.2 kilograms STANDARD_DEVIATION 15.6 • n=21 Participants	89.4 kilograms STANDARD_DEVIATION 14.0 • n=68 Participants
Hemoglobin A1c (%)	7.3 percent glycated hemoglobin STANDARD_DEVIATION 1.5 • n=23 Participants	8.2 percent glycated hemoglobin STANDARD_DEVIATION 1.3 • n=24 Participants	8.2 percent glycated hemoglobin STANDARD_DEVIATION 1.3 • n=21 Participants	7.9 percent glycated hemoglobin STANDARD_DEVIATION 1.4 • n=68 Participants
Body fat	39.4 Percent body fat n=23 Participants	39.8 Percent body fat n=24 Participants	41.6 Percent body fat n=21 Participants	40.4 Percent body fat n=68 Participants
Time in clinical hypoglycemia	3.5 Percent of time n=19 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.	3.3 Percent of time n=22 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.	4.1 Percent of time n=17 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.	3.6 Percent of time n=58 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.
Time in target glucose range	54.1 Percent of time STANDARD_DEVIATION 23.5 • n=19 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.	48.1 Percent of time STANDARD_DEVIATION 19.3 • n=22 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.	48.0 Percent of time STANDARD_DEVIATION 23.0 • n=17 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.	50.0 Percent of time STANDARD_DEVIATION 21.7 • n=58 Participants • N's are smaller than the numbers initially randomized due to missing continuous glucose monitoring data.

PRIMARY outcome

Timeframe: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=19 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=17 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=12 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Weight - Randomization 1	-1.6 kilograms Standard Deviation 3.4	-1.8 kilograms Standard Deviation 5.7	-1.5 kilograms Standard Deviation 3.2

PRIMARY outcome

Timeframe: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Population: Completers for each diet period were participants who had sufficient data to be rerandomized. However, one participant on the Mediterranean diet who had insufficient data to be rerandomized had available weight data and was included in the weight analysis. Therefore, there is one more participant assigned to the Mediterranean diet for the weight analysis.

Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=17 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=12 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Weight - Randomization 2	0.27 kilograms Standard Deviation 3.8	0.99 kilograms Standard Deviation 4.1	0.86 kilograms Standard Deviation 3.0

PRIMARY outcome

Timeframe: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Population: Data for one participant on the Mediterranean diet was excluded from analysis.

Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=14 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=9 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=16 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Weight - Randomization 3	0.68 kilograms Standard Deviation 2.4	-0.85 kilograms Standard Deviation 2.3	-0.64 kilograms Standard Deviation 3.4

PRIMARY outcome

Timeframe: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=19 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=17 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=12 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in HbA1C - Randomization 1	-0.03 Percent glycated hemoglobin Standard Deviation 0.55	-0.48 Percent glycated hemoglobin Standard Deviation 0.83	0.37 Percent glycated hemoglobin Standard Deviation 0.88

PRIMARY outcome

Timeframe: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=17 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=11 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in HbA1C - Randomization 2	-0.11 Percent glycated hemoglobin Standard Deviation 0.65	-0.008 Percent glycated hemoglobin Standard Deviation 0.52	-0.36 Percent glycated hemoglobin Standard Deviation 0.66

PRIMARY outcome

Timeframe: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=14 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=9 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=17 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in HbA1C - Randomization 3	0.25 Percent glycated hemoglobin Standard Deviation 0.72	0.72 Percent glycated hemoglobin Standard Deviation 1.7	-0.16 Percent glycated hemoglobin Standard Deviation 0.74

PRIMARY outcome

Timeframe: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring.

Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=15 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=9 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Time in Clinical Hypoglycemia - Randomization 1	-0.30 Percent of time Standard Deviation 4.1	0.65 Percent of time Standard Deviation 5.4	-0.45 Percent of time Standard Deviation 1.7

PRIMARY outcome

Timeframe: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring.

Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=12 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=9 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Time in Clinical Hypoglycemia - Randomization 2	0.2 Percent of time Standard Deviation 3.2	1.4 Percent of time Standard Deviation 4.2	2.6 Percent of time Standard Deviation 4.9

PRIMARY outcome

Timeframe: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring.

Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=8 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=15 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Time in Clinical Hypoglycemia - Randomization 3	0.086 Percent of time Standard Deviation 2.5	0.97 Percent of time Standard Deviation 4.4	-0.47 Percent of time Standard Deviation 5.3

SECONDARY outcome

Timeframe: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for dual-energy x-ray absorptiometry, which was discontinued following the transition to a virtual protocol due to COVID-19.

Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.

COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=16 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=12 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=10 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Body Fat - Randomization 1	-0.87 Percent body fat Standard Deviation 1.5	-0.058 Percent body fat Standard Deviation 1.2	-0.57 Percent body fat Standard Deviation 1.8

SECONDARY outcome

Timeframe: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for dual-energy x-ray absorptiometry, which was discontinued following the transition to a virtual protocol due to COVID-19.

Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.

COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=4 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=4 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=4 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Body Fat - Randomization 2	-0.38 Percentage of body fat Standard Deviation 2.7	-0.28 Percentage of body fat Standard Deviation 1.7	0.05 Percentage of body fat Standard Deviation 2.1

SECONDARY outcome

Timeframe: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for dual-energy x-ray absorptiometry, which was discontinued following the transition to a virtual protocol due to COVID-19.

Percent fat mass and percent fat free mass were measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period.

COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data continued, but no new DXA data were collected.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=2 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=1 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=1 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Body Fat - Randomization 3	1.4 Percent body fat Standard Deviation 0.7	0.1 Percent body fat	-0.9 Percent body fat

SECONDARY outcome

Timeframe: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring.

Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=15 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=9 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Time in Target Glucose Range - Randomization 1	6.3 Percent of time Standard Deviation 19.1	3.8 Percent of time Standard Deviation 15.1	-0.96 Percent of time Standard Deviation 13.1

SECONDARY outcome

Timeframe: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring.

Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=12 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=9 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Time in Target Glucose Range - Randomization 2	-0.60 Percent of time Standard Deviation 14.5	0.90 Percent of time Standard Deviation 14.4	1.0 Percent of time Standard Deviation 9.0

SECONDARY outcome

Timeframe: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit

Population: The number of participants analyzed is fewer than the number of participants who completed the randomization period in each diet group due to missing data for continuous glucose monitoring.

Change in percent of time spent in a pre-defined range of relative euglycemia (70-180 mg/dl, for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

Outcome measures

Measure	Hypocaloric, Low Carbohydrate n=13 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=8 Participants Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=15 Participants Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Change in Time in Target Glucose Range - Randomization 3	-2.1 Percent of time Standard Deviation 19.0	-18.4 Percent of time Standard Deviation 27.0	1.1 Percent of time Standard Deviation 14.3

Adverse Events

Hypocaloric, Low Carbohydrate

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Hypocaloric, Moderate Low Fat

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Mediterranean, no Caloric Restriction

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hypocaloric, Low Carbohydrate n=43 participants at risk Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=39 participants at risk Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=48 participants at risk Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Endocrine disorders Diabetic ketoacidosis	2.3% 1/43 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.6% 1/39 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/48 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.

Other adverse events

Measure	Hypocaloric, Low Carbohydrate n=43 participants at risk Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (\<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Hypocaloric, Moderate Low Fat n=39 participants at risk Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.	Mediterranean, no Caloric Restriction n=48 participants at risk Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Nervous system disorders Seizure - diagnosed epilepsy	2.3% 1/43 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/48 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Gastrointestinal disorders Hematemesis	0.00% 0/43 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.6% 1/39 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/48 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Gastrointestinal disorders Nausea and diarrhea	0.00% 0/43 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.1% 1/48 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
General disorders Cough and shortness of breath	2.3% 1/43 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.1% 1/48 • Number of events 2 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Endocrine disorders Hyperglycemia	0.00% 0/43 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	4.2% 2/48 • Number of events 2 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Reproductive system and breast disorders Suspected pregnancy	0.00% 0/43 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.1% 1/48 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Surgical and medical procedures Jaw inflammation - wisdom tooth removal	0.00% 0/43 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.1% 1/48 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
General disorders Headache	0.00% 0/43 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.1% 1/48 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Infections and infestations COVID-19 infection	2.3% 1/43 • Number of events 2 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/48 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Psychiatric disorders Panic attack	2.3% 1/43 • Number of events 2 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/48 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Skin and subcutaneous tissue disorders Abscess	2.3% 1/43 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/48 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.
Endocrine disorders Hypoglycemia	0.00% 0/43 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	0.00% 0/39 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.	2.1% 1/48 • Number of events 1 • 10.5 months per the study design, although participants who did not complete the study prior to the pandemic were monitored for a mean of 12.7 months due to study delays resulting from the COVID-19 pandemic.

Additional Information

Elizabeth Mayer-Davis, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-7218

Email: mayerdav@email.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place