New Strategies for Postprandial Glycemic Control Using Insulin Pump Therapy
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring T1DM, CSII, CGM, postprandial control, glycemic variability, Prandial insulin dosing in Type 1 diabetes treated with continuous subcutaneous insulin infusion
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 and 60 years
- Under CSII treatment for at least six months before Visit 1
- Body mass index of between 18 and 35 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), with a negative urine pregnancy tests
Exclusion Criteria:
- Pregnancy and lactation
- History of hypersensitivity to the study medications or to drugs with similar chemical structures
- Hypoglycemia 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
- Hospital Clínico Universitario
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
tBolus (traditional bolus)
iBolus (CGM-based insulin administration)
Traditional mealtime insulin bolus based on the individual insulin-to-CHO ratio
This is a CGM-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.