Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes, Glycemic Control, Continuous Glucose Monitoring
Brief summary
The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.
Detailed description
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.
Interventions
DEVICEGuardian RT Telemetered Glucose Monitoring System
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes for at least 12 months * HbA1c must be 8.1% or above at study entry * Intensive Insulin Therapy 3 months prior to study entry
Exclusion criteria
* Impaired hearing or vision (must see screens and hear alarms) * Unable to comply with protocol * Chronic debilitating or psychiatric disturbances
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Change in A1c (%) between continuous use of CGM and control | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Difference in change in A1c (%) between biweekly use of CGM and control | 12 weeks |
| Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM | 12 weeks |
Countries
France, Germany, Israel, Italy, Slovenia, Sweden, United Kingdom
Outcome results
None listed