NCT02258373

Brief Summary

The primary objective of the study is to determine whether the routine use of Continuous Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and effective as CGM used as an adjunct to BGM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 9, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

October 2, 2014

Results QC Date

March 6, 2018

Last Update Submit

August 8, 2018

Conditions

Type 1 Diabetes

Keywords

Diabetes MellitusContinuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

  • Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM

    Between baseline (randomization) and 6 months

Secondary Outcomes (17)

  • Mean Glucose

    Between baseline (randomization) and 6 months

  • Measures of Glycemic Variability: Coefficient of Variation

    Between baseline (randomization) and 6 months

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

    Between baseline (randomization) and 6 months

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

    Between baseline (randomization) and 6 months

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

    Between baseline (randomization) and 6 months

  • +12 more secondary outcomes

Study Arms (2)

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

CGM+BGMDEVICE

Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter

CGM+BGM
CGM OnlyDEVICE

Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm

CGM Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Southern California

Beverly Hills, California, 90211, United States

Location

Scripps Health

San Diego, California, 92121, United States

Location

Barbara Davis Center for Diabetes

Denver, Colorado, 80045, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Atlanta Diabetes

Atlanta, Georgia, 30318, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Iowa Diabetes and Endocrinology Center

Des Moines, Iowa, 50314, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5456, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

International Diabetes Center-Park Nicollet

Minneapolis, Minnesota, 55416, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-5160, United States

Location

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (2)

  • 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.

    PMID: 35099288DERIVED

  • 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.

    PMID: 28209654DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Katrina Ruedy
Organization
Jaeb Center for Health Research
kruedy@jaeb.org
8139758690

Study Officials

  • Katrina Ruedy, MSPH

    Jaeb Center for Health Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 7, 2014

Study Start

March 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 9, 2018

Results First Posted

August 9, 2018

Record last verified: 2018-08

Locations

US(14)