A Trial Comparing Continuous Glucose Monitoring With and... | NCT02258373

NCT02258373

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

CGM offers the opportunity to improve glycemic control, including a reduction in hypoglycemia. Unlike home blood glucose monitors, CGM is not intended to be used directly for making therapy adjustments and is an adjunctive device to supplement information obtained from a standard blood glucose monitor. However, although the labeling for CGM requires a BGM measurement before making a therapy adjustment, many CGM users often decide on a meal bolus based on CGM alone.

A study comparing CGM used solely as an adjunctive device, as per the FDA labeling, versus CGM used largely in lieu of BGM measurements would provide valuable data. Since many individuals with T1D are often using CGM alone when bolusing insulin, obtaining data on the safety and efficacy of this approach will be important. If indeed insulin dosing decisions are proven to be safe and effective using CGM alone (without BGM confirmation) compared to CGM with BGM confirmations, this study would also pave the way for a new standard diabetes management protocol and therapy that would not require eight BGM measurements (i.e. finger sticks) a day and ease the burden of managing type 1 diabetes.

For this study, participants will be randomly assigned with 2:1 probability to the CGM Only and CGM+BGM groups, respectively. Prior to randomization, the study will be preceded by a run-in period of up to 10 weeks to collect blinded baseline CGM data, to train the participants on CGM use, to assess compliance with CGM use, and to initiate standard CGM use. During the standard CGM use run-in phase, visits will occur after 2, 4 and 8 weeks, with phone calls at 1, 3, and 6 weeks. Current CGM users may be eligible to skip part of the run-in phase. Participants successfully completing the run-in phase will be randomized.

Both groups will use CGM devices and BGM. The CGM device to be used in the study is the Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm. The CGM+BGM group will be instructed to measure the blood glucose whenever a diabetes management decision is made. The CGM Only group will be instructed to only measure the blood glucose (other than for calibration) with a standard BGM meter in certain circumstances and will use a blinded BGM meter at times when a standard BGM measurement is not done. Following randomization, there will be a phone contact during the first week (4 to 8 days following randomization) to address any questions the participant has about the protocol. Follow up visits will occur at 3, 6, 13, 19 and 26 weeks.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CGM Only	Experimental	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.	Device: CGM Only
CGM+BGM	Active Comparator	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.	Device: CGM+BGM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CGM+BGM	Device	Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter	CGM+BGM

Outcomes Module

Measure	Description	Time Frame
Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM		Between baseline (randomization) and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Mean Glucose		Between baseline (randomization) and 6 months
Measures of Glycemic Variability: Coefficient of Variation	Coefficient of variation = SD/mean	Between baseline (randomization) and 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To be eligible, all participants must meet the following inclusion criteria:

Clinical diagnosis of type 1 diabetes (based on investigator's judgment)
Age >=18 years
T1D duration >=1
HbA1c <=9.0% (a local laboratory or DCA2000 or comparable point of care device will be used to assess eligibility)
Use of an insulin pump for insulin delivery for at least 3 months, with no plans to discontinue pump use during the next 8 months
Participant is able to manage his/her diabetes with respect to insulin administration and glucose monitoring, as assessed by the investigator during the screening visit
Participant understands the study protocol and agrees to comply with it, including willingness to use the study CGM and BGM
No expectation that participant will be moving out of the area of the clinical center during the time period of the study, unless the move will be to an area served by another study center

Exclusion Criteria:

Individuals who meet any of the following criteria are not eligible for the study:

Severe hypoglycemia in the last 12 months in which the assistance of another individual was needed or seizure/loss of consciousness in the past 3 years
Significant hypoglycemia unawareness based on the Clarke Hypoglycemia Unawareness Survey defined as at least one of the following being present:
- Survey score >2
- Survey Q1 is answered as 'I no longer have symptoms when my blood sugar is low'
- Survey Q7 response indicates that symptoms of hypoglycemia are not felt until glucose level is <50 mg/dl
- Survey Q8 response is never or rarely to the question 'to what extent can you tell by your symptoms that your blood sugar is low'
More than one DKA event in the past year
History of seizures other than due to hypoglycemia
Current use of a threshold suspend pump feature (note: participant is eligible if a pump with this feature was being used but the threshold suspend was not active)
Myocardial infarction or stroke in past 6 months
Estimated Glomerular Filtration Rate (GFR) <30 obtained within the prior 12 months as part of usual care or kidney transplant
Most recent thyroid function test results abnormal, obtained as part of usual care within the prior 2 years
The presence of a significant medical or psychiatric disorder or use of a medication that in the judgment of the investigator will affect the wearing of the sensors, the completion of any aspect of the protocol, or increase risk
Cognitive difficulties that, in the judgment of the investigator, could impair the individual's ability to follow the protocol or increase risk
Initiation of a non-insulin drug for glucose control during the past 3 months, planned initiation during the next 8 months, or discontinuation of a non-insulin drug for glucose control during the past 3 months (note: individuals using a non-insulin medication for glucose control for 3 or more months are eligible provided there is no expectation that the medication will be discontinued during the time period of study participation)
Use of a systemic beta blocker drug
Regular use of oral corticosteroids
Anticipated need to use acetaminophen during the time course of the study
Inpatient psychiatric treatment in the past 6 months
Currently pregnant or lactating or plan to attempt getting pregnant during the time period of the study

• Females with child-bearing potential will be queried about the possibility of pregnancy and a urine pregnancy test will be performed if there is uncertainty as to the possibility of pregnancy. They must agree to use appropriate birth control during the time period of the study. Participants will receive education regarding birth control methods which may be considered as highly effective, which are methods that can achieve a failure rate less than 1% per year when used consistently and correctly and include:
- Combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomised partner
- Sexual abstinence
Participation in an intervention study (including psychological studies) in past 6 weeks
Known adhesive allergy
From the blinded run-in phase (or from pre-study CGM use if criteria met to skip the blinded run-in phase), CGM values <60 mg/dl for more than 10.0% of the time
Unsuccessful completion of the run-in phases with respect to CGM or BGM use

Contacts/Locations Module

Name	Affiliation	Role
Katrina Ruedy, MSPH	Jaeb Center for Health Research	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California		Beverly Hills	California	90211	United States
Scripps Health

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35099288	Derived	Herrero P, Reddy M, Georgiou P, Oliver NS. Identifying Continuous Glucose Monitoring Data Using Machine Learning. Diabetes Technol Ther. 2022 Jun;24(6):403-408. doi: 10.1089/dia.2021.0498. Epub 2022 May 12.
28209654	Derived	Aleppo G, Ruedy KJ, Riddlesworth TD, Kruger DF, Peters AL, Hirsch I, Bergenstal RM, Toschi E, Ahmann AJ, Shah VN, Rickels MR, Bode BW, Philis-Tsimikas A, Pop-Busui R, Rodriguez H, Eyth E, Bhargava A, Kollman C, Beck RW; REPLACE-BG Study Group. REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes. Diabetes Care. 2017 Apr;40(4):538-545. doi: 10.2337/dc16-2482. Epub 2017 Feb 16.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00063± 13 OG00165± 11

Secondary

Mean Glucose

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.

Posted

Mean

Standard Deviation

mg/dl

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Measures of Glycemic Variability: Coefficient of Variation

Coefficient of variation = SD/mean

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.

Posted

Median

Inter-Quartile Range

percent

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Time With Sensor Value <70 mg/dl, Measured With CGM

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.

Posted

Median

Inter-Quartile Range

percentage of time

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Time With Sensor Values <60 mg/dl, Measured With CGM

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.

Posted

Median

Inter-Quartile Range

percentage of time

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Time With Sensor Values <50 mg/dl, Measured With CGM

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.

Posted

Median

Inter-Quartile Range

percentage of time

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Days With at Least 20 Minutes of Sensor Glucose Values <60 mg/dl

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.

Posted

Median

Inter-Quartile Range

percentage of days

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Time With Sensor Values >180 mg/dl, Measured With CGM

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.

Posted

Median

Inter-Quartile Range

percentage of time

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Time With Sensor Values > 250 mg/dl, Measured With CGM

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.

Posted

Median

Inter-Quartile Range

percentage of time

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Time With Sensor Values > 300 mg/dl, Measured With CGM

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.

Posted

Median

Inter-Quartile Range

percentage of time

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Percentage of Days With at Least 20 Minutes of Sensor Glucose Values >300 mg/dl

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.

Posted

Median

Inter-Quartile Range

percentage of days

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Change in HbA1c

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

Posted

Mean

Standard Deviation

mmol/mol

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event

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

Posted

Count of Participants

Participants

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With >=1 Severe Hypoglycemia Events

Posted

Count of Participants

Participants

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With >=1 Diabetic Ketoacidosis (DKA) Events

Posted

Count of Participants

Participants

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=0.6 mmol/L

Posted

Count of Participants

Participants

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=1.0 mmol/L

Posted

Count of Participants

Participants

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With >=1 Serious Adverse Event Other Than SH

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.

Posted

Count of Participants

Participants

Between baseline (randomization) and 6 months

ID	Title	Description
OG000	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
OG001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	149	4	149	6	149
EG001	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	0	77	4	77	3	77

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Basedow's disease	Endocrine disorders	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected149 at risk EG0012 events1 affected77 at risk
Knee arthroplasty	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected149 at risk EG0011 events1 affected77 at risk
Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected149 at risk EG0011 events1 affected77 at risk
Hypoglycaemic seizure	Nervous system disorders	Systematic Assessment	EG0000 events0 affected149 at risk EG0011 events1 affected77 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected149 at risk EG0011 events1 affected77 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 events1 affected149 at risk EG0010 events0 affected77 at risk
Folliculitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Hyperglycaemia	Endocrine disorders	Systematic Assessment	EG0002 events2 affected149 at risk EG0010 events0 affected77 at risk
Skin lesion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected149 at risk EG0010 events0 affected77 at risk
Skin abrasion	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected149 at risk EG0011 events1 affected77 at risk
Presyncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected149 at risk EG0011 events1 affected77 at risk

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases