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Type 1 DiabetesREPLACE-BGNCT02258373

A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes

A study testing CGM+BGM and CGM Only in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
CGM+BGM and CGM Only
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
14 sitesUnited States
Study dates
Mar 2015to Oct 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109-5456

  • Atlanta Diabetes

    Atlanta, Georgia, 30318

  • University of Southern California

    Beverly Hills, California, 90211

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • Barbara Davis Center for Diabetes

    Denver, Colorado, 80045

  • Iowa Diabetes and Endocrinology Center

    Des Moines, Iowa, 50314

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • International Diabetes Center-Park Nicollet

    Minneapolis, Minnesota, 55416

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-5160

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Scripps Health

    San Diego, California, 92121

  • University of Washington

    Seattle, Washington, 98105

  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes

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.

Read the 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
Type 1 Diabetes
Being tested
CGM+BGM, CGM Only
Keywords
Diabetes Mellitus, Continuous Glucose Monitoring
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGM+BGMDevice

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

  • CGM OnlyDevice

    Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm

Study groups in NCT02258373
Study groupRoleWhat they receive
CGM OnlyExperimentalParticipants 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.
Receives: Device: CGM Only
CGM+BGMActive comparatorParticipants 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.
Receives: Device: CGM+BGM

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Between baseline (randomization) and 6 months

Secondary outcomes (17)

  1. Mean Glucose

    Measured: Between baseline (randomization) and 6 months

  2. Measures of Glycemic Variability: Coefficient of Variation

    Coefficient of variation = SD/mean

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

  11. Change in HbA1c

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

  13. Number of Participants With >=1 Severe Hypoglycemia Events

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

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

    Measured: Between baseline (randomization) and 6 months

  17. 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.

    Measured: Between baseline (randomization) and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02258373
Sponsor's protocol ID
T1DX-REPLACE-BG
Acronym
REPLACE-BG
Status last verified
Aug 2018
First submitted
2 Oct 2014
Last updated
9 Aug 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35099288

  • 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.

    PubMed 28209654

Questions about this trial

What is this clinical trial studying?

A study testing CGM+BGM and CGM Only in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM (time frame: Between baseline (randomization) and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02258373, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.

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