Phase 4 N=74

Continuous Glucose Sensor Profiles in Non-Diabetic Subjects

Healthy Subjects Without Type 1 Diabetes

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View on ClinicalTrials.gov: NCT00717977 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2010

Primary outcome: Primary: Overall Mean Sensor Glucose by Age Group — 98; 103; 97; 96 mg/dL — p=0.009

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Continuous glucose monitor (Device)
Age: Pediatric, Adult, Older Adult · 8+ yrs
Sex: All
Sponsor: Jaeb Center for Health Research
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Mean Sensor Glucose by Age Group	98; 103; 97; 96; 95	0.009 sig
PRIMARY Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group	99; 103; 98; 97; 97	0.04 sig
PRIMARY Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group	95; 101; 97; 91; 89	<0.001 sig
PRIMARY Peak Daytime Sensor Glucose Value by Age Group	131; 134; 135; 125; 128	—
PRIMARY Peak Nightime Sensor Glucose Value by Age Group	109; 111; 111; 104; 103	—
PRIMARY Daytime Nadir Sensor Glucose Value by Age Group	73; 74; 71; 75; 79	—
PRIMARY Nighttime Nadir Sensor Glucose Value by Age Group	80; 84; 80; 77; 78	—
PRIMARY Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group	91.0; 85.1; 87.9; 91.4; 93.7	—
PRIMARY Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day	90.4; 90.3	—
PRIMARY Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group	1.7; 1.8; 0.6; 2.9; 1.6	—
PRIMARY Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day	1.1; 2.2	—
PRIMARY Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group	0.2; 0.2; 0.0; 0.2; 0.1	—
PRIMARY Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day	0.0; 0.0	—
PRIMARY Percentage of Sensor Glucose Levels >120 mg/dL by Age Group	5.6; 8.2; 8.3; 4.2; 4.4	—
PRIMARY Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day	5.9; 1.1	—
PRIMARY Percentage of Sensor Glucose Levels >140 mg/dL by Age Group	0.4; 1.3; 0.3; 0.3; 0.0	—
PRIMARY Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day	0.5; 0.0	—
PRIMARY Glucose Variability Measure- Standard Deviation by Age Group	13.7; 16.4; 13.7; 12.6; 12.4	—
PRIMARY Glucose Variability Measure- Standard Deviation by Time of Day	13.5; 10.9	—
PRIMARY Glucose Variability Measure- Absolute Rate of Change by Age Group	0.34; 0.36; 0.34; 0.32; 0.33	—
PRIMARY Glucose Variability Measure- Absolute Rate of Change by Time of Day	0.37; 0.26	—
PRIMARY Glucose Variability Measure- Coefficient of Variation by Age Group	14; 16; 14; 14; 13	—
PRIMARY Glucose Variability Measure- Coefficient of Variation by Time of Day	14; 12	—
PRIMARY Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group	27.7; 28.1; 28.3; 25.6; 26.9	—
PRIMARY Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day	28.0; 15.8	—

Summary

The Juvenile Diabetes Research Foundation (JDRF) Glucose Sensor Study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (RT-CGM) as an adjunct to standard meter plasma glucose testing. Although the primary outcome in the >= 7.0% cohort is differences in HbA1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. Prevention of biochemical hypoglycemia is a particularly important outcome in the low HbA1c cohort. Since CGM systems measure interstitial rather than plasma glucose and CGM values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. The objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the JDRF study.

Eligibility Criteria

Inclusion Criteria

Age > 8 years
Body mass index (BMI) between the 10th to 90th percentile for age and sex (based on CDC, 2000 nomogram) and < 28 kg body weight/meter in adult subjects
No significant chronic illness or taking any acute or chronic medications that might affect glucose metabolism.

Exclusion Criteria

History of diabetes or positive islet cell antibody testing

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00717977). 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.