Effect of Different Plasma Insulin Levels on the Accuracy of Continuous Subcutaneous Glucose Monitoring
Type 1 Diabetes, Continuous Glucose Monitoring, Hypoglycemia
About this trial
This is an interventional basic science trial for Type 1 Diabetes focused on measuring Interstitial glucose dynamics, Accuracy of continuous glucose monitoring under hypoglycemia, Glucose clamp
Eligibility Criteria
Inclusion Criteria:
Subjects with type 1 diabetes mellitus meeting all of the following criteria will be considered for admission to the study:
- Aged between 18 and 60 years
- Under CSII or MDI treatment for at least six months before Visit 1
- Body mass index of between 18 and 30 kg/m2
- HbA1c 6.0-8.5% at Visit 1
- Normal laboratory values, ECG, and vital signs unless the investigator considered an abnormality to be clinically irrelevant
- Women postmenopausal or using contraception judged by the investigator to be adequate (e.g., oral contraceptives, intra-uterine device or surgical treatment)
Exclusion Criteria:
Subjects meeting any of the following criteria will not be included in the study:
- Pregnancy and lactation
- History of hypersensitivity to the study medications or to drugs with similar chemical structures
- Confirmed hypoglycaemia unawareness
- Progressive fatal diseases
- History of drug or alcohol abuse
- History of positive HIV or hepatitis B or C test
- Impaired hepatic function, as shown by, but not limited to, SGPT or SGOT of more than twice the upper limit of the normal range at visit 1
- Impaired renal function, as shown by, but not limited to, serum creatinine > 1.5 mg/dL at visit 1
- Clinically relevant microvascular, cardiovascular, hepatic, neurologic, endocrine or other major systemic diseases other than T1DM which could hinder implementation of the clinical study protocol or interpretation of the study results
- Pre-planned surgery during the study
- Blood donation of more than 500 ml during the past three months for men, or during the past six months for women
- Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- Subject unlikely to comply with clinical study protocol, e.g., uncooperative attitude, inability to return for follow-up visits, or poor likelihood of completing the study
- Receipt of an experimental drug or use of an experimental device during the past 30 days.
Sites / Locations
- Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valencia
Arms of the Study
Arm 1
Arm 2
Other
Other
High plasma insulin-Low plasma insulin
Low plasma insulin-High plasma insulin
Seven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a High insulin glucose clamp and on the second day a Low insulin glucose clamp (sequence 'AB')
Seven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a Low insulin glucose clamp and on the second day a High insulin glucose clamp (sequence 'BA')