Trial Outcomes & Findings for A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes (NCT NCT02258373)

NCT ID: NCT02258373

Last Updated: 2018-08-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 226 participants
• Primary outcome timeframe: Between baseline (randomization) and 6 months
• Results posted on: 2018-08-09

Participant Flow

Participant milestones

Measure	CGM Only Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Overall Study STARTED	149	77
Overall Study COMPLETED	142	75
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.

Baseline characteristics by cohort

Measure	CGM Only n=149 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter	Total n=226 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 14 • n=149 Participants	45 years STANDARD_DEVIATION 13 • n=77 Participants	44 years STANDARD_DEVIATION 14 • n=226 Participants
Sex: Female, Male Female	71 Participants n=149 Participants	41 Participants n=77 Participants	112 Participants n=226 Participants
Sex: Female, Male Male	78 Participants n=149 Participants	36 Participants n=77 Participants	114 Participants n=226 Participants
Race/Ethnicity, Customized Race/Ethnicity · White non-Hispanic	139 Participants n=149 Participants	68 Participants n=77 Participants	207 Participants n=226 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic or Latino	4 Participants n=149 Participants	5 Participants n=77 Participants	9 Participants n=226 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	4 Participants n=149 Participants	1 Participants n=77 Participants	5 Participants n=226 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	2 Participants n=149 Participants	2 Participants n=77 Participants	4 Participants n=226 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other/unknown	0 Participants n=149 Participants	1 Participants n=77 Participants	1 Participants n=226 Participants
Region of Enrollment United States	149 Participants n=149 Participants	77 Participants n=77 Participants	226 Participants n=226 Participants
BMI	27.7 kg/m2 STANDARD_DEVIATION 4.1 • n=149 Participants	26.5 kg/m2 STANDARD_DEVIATION 4.9 • n=77 Participants	27.3 kg/m2 STANDARD_DEVIATION 4.4 • n=226 Participants
Diabetes Duration	23 years STANDARD_DEVIATION 12 • n=149 Participants	25 years STANDARD_DEVIATION 12 • n=77 Participants	24 years STANDARD_DEVIATION 12 • n=226 Participants
Annual Household Income ($) <50,000	18 Participants n=111 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.	7 Participants n=57 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.	25 Participants n=168 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.
Annual Household Income ($) 50,000-<100,000	39 Participants n=111 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.	17 Participants n=57 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.	56 Participants n=168 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.
Annual Household Income ($) >=100,000	54 Participants n=111 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.	33 Participants n=57 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.	87 Participants n=168 Participants • Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.
Highest Education <Bachelor's Degree	35 Participants n=148 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.	12 Participants n=73 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.	47 Participants n=221 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.
Highest Education Bachelor's Degree	75 Participants n=148 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.	35 Participants n=73 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.	110 Participants n=221 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.
Highest Education Post-Bachelor's Degree	38 Participants n=148 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.	26 Participants n=73 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.	64 Participants n=221 Participants • Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.
Insurance Private	132 Participants n=149 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.	66 Participants n=75 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.	198 Participants n=224 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.
Insurance Other	15 Participants n=149 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.	7 Participants n=75 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.	22 Participants n=224 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.
Insurance None	2 Participants n=149 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.	2 Participants n=75 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.	4 Participants n=224 Participants • Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.
CGM Use Before Study Never used CGM	26 Participants n=149 Participants	14 Participants n=77 Participants	40 Participants n=226 Participants
CGM Use Before Study In past, but not current	54 Participants n=149 Participants	25 Participants n=77 Participants	79 Participants n=226 Participants
CGM Use Before Study Current Dexcom CGM user	49 Participants n=149 Participants	28 Participants n=77 Participants	77 Participants n=226 Participants
CGM Use Before Study Current Medtronic CGM user	20 Participants n=149 Participants	10 Participants n=77 Participants	30 Participants n=226 Participants
Central Laboratory HbA1c Value <7.0% (53 mmol/mol)	59 Participants n=149 Participants	39 Participants n=77 Participants	98 Participants n=226 Participants
Central Laboratory HbA1c Value 7.0%-<8.0% (53-<64 mmol/mol)	79 Participants n=149 Participants	31 Participants n=77 Participants	110 Participants n=226 Participants
Central Laboratory HbA1c Value >=8.0% (64 mmol/mol)	11 Participants n=149 Participants	7 Participants n=77 Participants	18 Participants n=226 Participants
Self-reported BGM Testing	5.2 tests/day STANDARD_DEVIATION 2.1 • n=149 Participants	4.9 tests/day STANDARD_DEVIATION 1.9 • n=77 Participants	5.1 tests/day STANDARD_DEVIATION 2.0 • n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 0	100 Participants n=149 Participants	53 Participants n=77 Participants	153 Participants n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 1	34 Participants n=149 Participants	14 Participants n=77 Participants	48 Participants n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 2	15 Participants n=149 Participants	10 Participants n=77 Participants	25 Participants n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 3	0 Participants n=149 Participants	0 Participants n=77 Participants	0 Participants n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 4	0 Participants n=149 Participants	0 Participants n=77 Participants	0 Participants n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 5	0 Participants n=149 Participants	0 Participants n=77 Participants	0 Participants n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 6	0 Participants n=149 Participants	0 Participants n=77 Participants	0 Participants n=226 Participants
Clarke Hypoglycemia Unawareness Survey Total Score 7	0 Participants n=149 Participants	0 Participants n=77 Participants	0 Participants n=226 Participants

PRIMARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM	63 percentage of time Standard Deviation 13	65 percentage of time Standard Deviation 11

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Mean Glucose	162 mg/dl Standard Deviation 23	158 mg/dl Standard Deviation 20

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Coefficient of variation = SD/mean

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Measures of Glycemic Variability: Coefficient of Variation	37 percent Interval 34.0 to 41.0	37 percent Interval 34.0 to 40.0

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Time With Sensor Value <70 mg/dl, Measured With CGM	3.0 percentage of time Interval 1.6 to 5.1	3.7 percentage of time Interval 1.9 to 4.9

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Time With Sensor Values <60 mg/dl, Measured With CGM	1.3 percentage of time Interval 0.5 to 2.4	1.6 percentage of time Interval 0.6 to 2.2

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Time With Sensor Values <50 mg/dl, Measured With CGM	0.4 percentage of time Interval 0.2 to 0.8	0.5 percentage of time Interval 0.2 to 0.8

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Days With at Least 20 Minutes of Sensor Glucose Values <60 mg/dl	28 percentage of days Interval 13.0 to 42.0	32 percentage of days Interval 16.0 to 46.0

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Time With Sensor Values >180 mg/dl, Measured With CGM	35 percentage of time Interval 25.0 to 41.0	31 percentage of time Interval 24.0 to 38.0

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Time With Sensor Values > 250 mg/dl, Measured With CGM	9 percentage of time Interval 5.0 to 13.0	7 percentage of time Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Time With Sensor Values > 300 mg/dl, Measured With CGM	2 percentage of time Interval 1.0 to 4.0	2 percentage of time Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.

Outcome measures

Measure	CGM Only n=148 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=76 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Percentage of Days With at Least 20 Minutes of Sensor Glucose Values >300 mg/dl	27 percentage of days Interval 14.0 to 40.0	20 percentage of days Interval 10.0 to 37.0

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.

Outcome measures

Measure	CGM Only n=142 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=75 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Change in HbA1c	0.0 mmol/mol Standard Deviation 5.5	0.0 mmol/mol Standard Deviation 5.5

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Population: Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.

Outcome measures

Measure	CGM Only n=142 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=75 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event	115 Participants	54 Participants

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Outcome measures

Measure	CGM Only n=149 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Number of Participants With >=1 Severe Hypoglycemia Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Outcome measures

Measure	CGM Only n=149 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Number of Participants With >=1 Diabetic Ketoacidosis (DKA) Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Outcome measures

Measure	CGM Only n=149 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=0.6 mmol/L	48 Participants	26 Participants

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

Outcome measures

Measure	CGM Only n=149 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=1.0 mmol/L	27 Participants	15 Participants

SECONDARY outcome

Timeframe: Between baseline (randomization) and 6 months

A serious adverse event is any untoward occurrence that:

• Results in death.
• Is life-threatening; (a non-life-threatening event which, had it been more severe, might have become life-threatening, is not necessarily considered a serious adverse event).
• Requires inpatient hospitalization or prolongation of existing hospitalization.
• Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (sight threatening).
• Is a congenital anomaly or birth defect.
• Is considered a significant medical event by the investigator based on medical judgment.

Outcome measures

Measure	CGM Only n=149 Participants Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 Participants Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Number of Participants With >=1 Serious Adverse Event Other Than SH	4 Participants	3 Participants

Adverse Events

CGM Only

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

CGM+BGM

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	CGM Only n=149 participants at risk Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 participants at risk Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Cardiac disorders Tachycardia	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Cardiac disorders Myocardial infarction	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Endocrine disorders Basedow's disease	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Renal and urinary disorders Nephrolithiasis	0.00% 0/149 • Between baseline (randomization) and 6 months	1.3% 1/77 • Number of events 2 • Between baseline (randomization) and 6 months
Surgical and medical procedures Knee arthroplasty	0.00% 0/149 • Between baseline (randomization) and 6 months	1.3% 1/77 • Number of events 1 • Between baseline (randomization) and 6 months
Injury, poisoning and procedural complications Injury	0.00% 0/149 • Between baseline (randomization) and 6 months	1.3% 1/77 • Number of events 1 • Between baseline (randomization) and 6 months
Nervous system disorders Hypoglycaemic seizure	0.00% 0/149 • Between baseline (randomization) and 6 months	1.3% 1/77 • Number of events 1 • Between baseline (randomization) and 6 months

Other adverse events

Measure	CGM Only n=149 participants at risk Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous. In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times. CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm	CGM+BGM n=77 participants at risk Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires. CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
Skin and subcutaneous tissue disorders Rash	1.3% 2/149 • Number of events 2 • Between baseline (randomization) and 6 months	1.3% 1/77 • Number of events 1 • Between baseline (randomization) and 6 months
Skin and subcutaneous tissue disorders Dermatitis allergic	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.67% 1/149 • Number of events 5 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Skin and subcutaneous tissue disorders Folliculitis	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Infections and infestations Infection	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Endocrine disorders Hyperglycaemia	1.3% 2/149 • Number of events 2 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Skin and subcutaneous tissue disorders Skin lesion	0.67% 1/149 • Number of events 1 • Between baseline (randomization) and 6 months	0.00% 0/77 • Between baseline (randomization) and 6 months
Skin and subcutaneous tissue disorders Skin abrasion	0.00% 0/149 • Between baseline (randomization) and 6 months	1.3% 1/77 • Number of events 1 • Between baseline (randomization) and 6 months
Nervous system disorders Presyncope	0.00% 0/149 • Between baseline (randomization) and 6 months	1.3% 1/77 • Number of events 1 • Between baseline (randomization) and 6 months

Additional Information

Katrina Ruedy

Jaeb Center for Health Research

Phone: 8139758690

Email: kruedy@jaeb.org

Results disclosure agreements

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