Factors in Accuracy Studies Influencing Measured CGM Performance.
Diabetes MellitusType 1Primary objective is to assess the impact of different reference glucose measurement methods on the measured performance of a CGM system, aiming at further standardization for the assessment of CGM systems. Secondary objective is to describe the relationship between glucose concentration of venous, capillary and arterialized-venous measurement samples. Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes aged 18 years and older will be included. Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the clinical research center (CRC) twice during a 6 day period. These visits will have a duration of 8 hours. Blood will be drawn for the determination of glucose concentrations using venous, arterialized-venous and capillary sampling techniques. The patient will receive his usual breakfast and an increased insulin bolus will be administered to correct the breakfast glucose excursion with the aim of inducing a period of minor hypoglycemia. Blood sampling will continue until the end of the admission. The sensor will be worn until the end of the second 8-hour CRC session, which will be planned on day 6 or earlier depending on patient preference. The sensor will be removed and their sensor and blood glucose meter data downloaded from the devices. In the case of sensor failure before the first CRC session, patients will be instructed to insert a new sensor per the manufacturer's instruction and to notify study staff of the event. In case of failure of the sensor after the first CRC session but before the second CRC session, patients will return to the CRC for sensor removal and for data download.
Insulin Bolus Required for High Fat Foods in Type 1 Diabetes
Type 1 DiabetesThe purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals. Subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The investigators hypothesize that the incremental insulin dose required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (U/kg).
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
Type 1 Diabetes MellitusCognitive ChangeThe objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing...
Diabetes MellitusType 1The purpose of the proposed study is to compare insulin Degludec [TRESIBA® (insulin degludec injection)] with insulin Glargine U100 [Lantus® (insulin glargine injection)] to determine the basal insulin of choice for adults with type 1 diabetes (T1D) who fly non-stop across multiple time zones. With the introduction of Degludec as basal insulin for T1D and the opportunity to vary time of injection between 8 and 40 hours, the use of Degludec as a basal insulin may make it easier for both people living with T1D and diabetologists to plan long-haul travel compared to the use of existing basal insulins when crossing multiple time zones.The study hypothesis is that once daily Degludec as the basal insulin will provide better glycemic control for people with type 1 diabetes on multiple daily injections who are traveling non-stop across multiple time zones than once daily Glargine U100.
A Study of LY900014 in a Medtronic Pump
Type1 Diabetes MellitusThe purpose of this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are delivered by the Medtronic MiniMed 670G System in adults with type 1 diabetes (T1D). The study will consist of two treatment periods of 4 weeks.
CharacterIzation of Adult Onset Autoimmune Diabetes
DiabetesThe purpose of the study is to identify new biomarkers of Adult Onset Autoimmune Diabetes (AOnAD).
Feasibility Studies of Personalized Closed Loop
Type 1 DiabetesThis is a single arm study comprised of a series of feasibility studies.
A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1...
Type 1 Diabetes MellitusThe goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in...
Diabetes MellitusType 11 moreThis is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
Type 1 DiabetesSubjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.