N/A
Completed N=226
A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes
Source: ClinicalTrials.gov NCT02258373 ↗Enrolled (actual)
226
Serious AEs
3.5%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM — 63; 65 percentage of time
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM |
63; 65 | — |
| SECONDARY Mean Glucose |
162; 158 | — |
| SECONDARY Measures of Glycemic Variability: Coefficient of Variation |
37; 37 | — |
| SECONDARY Percentage of Time With Sensor Value <70 mg/dl, Measured With CGM |
3.0; 3.7 | — |
| SECONDARY Percentage of Time With Sensor Values <60 mg/dl, Measured With CGM |
1.3; 1.6 | — |
| SECONDARY Percentage of Time With Sensor Values <50 mg/dl, Measured With CGM |
0.4; 0.5 | — |
| SECONDARY Percentage of Days With at Least 20 Minutes of Sensor Glucose Values <60 mg/dl |
28; 32 | — |
| SECONDARY Percentage of Time With Sensor Values >180 mg/dl, Measured With CGM |
35; 31 | — |
| SECONDARY Percentage of Time With Sensor Values > 250 mg/dl, Measured With CGM |
9; 7 | — |
| SECONDARY Percentage of Time With Sensor Values > 300 mg/dl, Measured With CGM |
2; 2 | — |
| SECONDARY Percentage of Days With at Least 20 Minutes of Sensor Glucose Values >300 mg/dl |
27; 20 | — |
| SECONDARY Change in HbA1c |
0.0; 0.0 | — |
| SECONDARY Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event |
115; 54 | — |
| SECONDARY Number of Participants With >=1 Severe Hypoglycemia Events |
0; 1 | — |
| SECONDARY Number of Participants With >=1 Diabetic Ketoacidosis (DKA) Events |
0; 0 | — |
| SECONDARY Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=0.6 mmol/L |
48; 26 | — |
| SECONDARY Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=1.0 mmol/L |
27; 15 | — |
| SECONDARY Number of Participants With >=1 Serious Adverse Event Other Than SH |
4; 3 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02258373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.