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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:March 2015
End Date:October 2016

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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.

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.

Inclusion Criteria:

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

1. Clinical diagnosis of type 1 diabetes (based on investigator's judgment)

2. Age >=18 years

3. T1D duration >=1

4. HbA1c <=9.0% (a local laboratory or DCA2000 or comparable point of care device will be
used to assess eligibility)

5. 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

6. 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

7. Participant understands the study protocol and agrees to comply with it, including
willingness to use the study CGM and BGM

8. 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:

1. 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

2. 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'

3. More than one DKA event in the past year

4. History of seizures other than due to hypoglycemia

5. 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)

6. Myocardial infarction or stroke in past 6 months

7. Estimated Glomerular Filtration Rate (GFR) <30 obtained within the prior 12 months as
part of usual care or kidney transplant

8. Most recent thyroid function test results abnormal, obtained as part of usual care
within the prior 2 years

9. 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

10. Cognitive difficulties that, in the judgment of the investigator, could impair the
individual's ability to follow the protocol or increase risk

11. 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)

12. Use of a systemic beta blocker drug

13. Regular use of oral corticosteroids

14. Anticipated need to use acetaminophen during the time course of the study

15. Inpatient psychiatric treatment in the past 6 months

16. 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

17. Participation in an intervention study (including psychological studies) in past 6
weeks

18. Known adhesive allergy

19. 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

20. Unsuccessful completion of the run-in phases with respect to CGM or BGM use
We found this trial at
14
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30318
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Beverly Hills, California 90211
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Beverly Hills, CA
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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303 East Superior Street
Chicago, Illinois 60611
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Denver, Colorado 80045
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Detroit, Michigan 48202
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Minneapolis, Minnesota 55416
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Minneapolis, MN
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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San Diego, California 92121
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San Diego, CA
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