Status:
COMPLETED
A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes
Lead Sponsor:
Jaeb Center for Health Research
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 us...
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 adjustment...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT02258373
Start Date
March 1 2015
End Date
October 1 2016
Last Update
August 9 2018
Active Locations (14)
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1
University of Southern California
Beverly Hills, California, United States, 90211
2
Scripps Health
San Diego, California, United States, 92121
3
Barbara Davis Center for Diabetes
Denver, Colorado, United States, 80045
4
University of South Florida
Tampa, Florida, United States, 33612