Status:
UNKNOWN
Mixed Meal Test in Type 1 Diabetes: Optimization of Artificial Pancreas-Pilot Study
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsors:
Universita di Verona
Conditions:
Diabetes Mellitus Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Physiology studies will be performed in patients with type 1 diabetes to define during a standardized mixed meal test: 1. The relationship between fast insulin analogue administration by i.v. infusion...
Detailed Description
The maintenance of close-to-normal blood glucose levels slows the onset and progression of long-term microvascular, and possibly macrovascular, complications in patients with type 1 diabetes. Artifici...
Eligibility Criteria
Inclusion
- patient must be aged between 18 (inclusive) and 65 years old;
- patient must have been diagnosed with type 1 diabetes(positive islet cell antibodies;
- use of an insulin pump to treat his/her diabetes for at least 1 year;
- actively using a carbohydrate/insulin ratio for insulin bolus adjustments in order to keep blood glucose in a predefined range;
- patient HbA1c is between 6,0% and 9,0% (standardized with DCCT);
- patient must be willing to avoid consumption of acetaminophen containing products during the study involving DexCom (one CGM system which will be employed in this study) use;
- patient must demonstrate proper mental status and cognition for the study;
- patient has signed informed consent from prior to study entry.
Exclusion
- diabetic ketoacidosis within the 6 months prior to enrollment;
- severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment;
- pregnancy and breast feeding;
- uncontrolled microvascular (diabetic)complications (other than diabetic non-proliferative retinopathy)such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment;
- uncontrolled arterial hypertension (diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg);
- conditions which may increase the risk of hypoglycemia such as uncontrolled coronary artery disease during the previous year (e.g. history of myocardial infarction, acute coronary syndrome, therapeutic coronary intervention, coronary bypass or stenting procedure, stable or unstable angina, episode of chest pain of cardiac etiology with documented EKG changes, or positive stress test or catheterization with coronary blockages \>50%), congestive heart failure, history of cerebrovascular event, seizure disorder, syncope, adrenal insufficiency, neurologic disease or atrial fibrillation;
- drugs affecting glucose metabolism (oral steroids, thiazide diuretic, beta-blockers,beta-agonist, nicotinic acid, immunosuppressant agents, antiretroviral drugs and antipsychotics);
- impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase \> three times the upper reference limit;
- impaired renal function measured as creatinine \>1.2 times above the upper limit of normal;
- anticoagulant therapy other than aspirin;
- known current or recent alcohol or drug abuse;
- psychiatric disorders that would interfere with study tasks (e.g. inpatient psychiatric treatment within 6 months prior to enrollment);
- mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01800734
Start Date
October 1 2012
End Date
February 1 2015
Last Update
November 19 2013
Active Locations (1)
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1
Division of Endocrinology and Metabolic Diseases - University Hospital of Verona-Piazzale Stefani 1
Verona, Italy, 37126