A Phase 1/2 interventional study of BD Research Catheter with 34G x 1.5 mm needle and Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set in Diabetes, sponsored by Becton, Dickinson and Company. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2011-04-18.
Sponsored by Becton, Dickinson and Company · Phase 1/2, Interventional, and Basic science
The purpose of this study is to compare the effects of bolus delivery of insulin when delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics.
Each patient will participate in 10 visits of which the first, Visit 1, is a Screening Visit.
Visit 2 will consist of a brief isoglycemic clamp with a single IV insulin challenge to determine insulin sensitivity. A subsequent test meal and single SC insulin dose (off clamp) will be done to determine the nominal coverage dose of insulin for a mixed meal containing 60g of carbohydrate. This nominal dose will form the basis of insulin bolus dosing for the remainder of the study visits.
For Visits 3-9, patients will come to the institute in the early morning 24 hours prior to the meal test for the application of a Continuous Glucose Monitor (Dexcom Seven Plus™, Dexcom, INC). Subjects will receive standardized meals during the day and their blood glucose will be stabilized overnight to a concentration of 115±15 mg/dL via IV insulin and/or glucose infusions. The next morning the subjects will start the experimental intervention. Immediately prior to standardized meals (2 minutes before eating) the patients will receive insulin by either the ID or SC route, followed by the breakfast (rapidly absorbed carb) meal at time point T0. Meal consumption will occur over a 10 to 15 min time interval. Blood glucose excursions will be observed in the 6 hours thereafter (until T= 360 min). Between hours 6 to 7, BG may be re-stabilized to starting values (115±15 mg/dL) by administration of IV insulin or glucose if necessary. At that time a second insulin injection (same dose as at time point T= -2 minutes) will be given and a second standardized lunch (mixed) meal will be administered. Blood glucose excursions will be followed for an additional 6 hours thereafter (T = 780 minutes)
Conditions for Visits 3-8 will be:
In addition during each meal challenge the subject will be maintained on an Animas pump intradermally delivering a combined bolus and basal profile of a placebo (5% dextrose for injection solution) during the study period to evaluate flow biomechanics.
Visit 9 will examine a single earlier dose timing (determined by analysis of the glycemic profile dataset from the prior 8 visits) relative to the two meals for the ID route only, using the optimal target dose from conditions 1 and 2.
Patients will have a final examination, Visit 10, immediately following Visit 9.
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Male and female patients will be included in the trial only if they fulfill all of the inclusion criteria mentioned below:
Exclusion Criteria:
Patients will not be permitted to enter the trial, if they fulfill any of the exclusion criteria mentioned below:
A bolus dose of insulin will be given subcutaneously just prior to a standardized meal.
Device: Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set
A bolus dose of insulin will be given intradermally just prior to a standardized meal
Device: BD Research Catheter with 34G x 1.5 mm needle
bolus injection of insulin given intradermal prior to standardized meal
bolus delivery of insulin given subcutaneously prior to standardized meal
Also known as: Disetronic Accu-Chek Rapid D infusion set - 6mm cannula
Blood Glucose
To compare between the ID and SC routes the relative PD times "in-range" (70-180 mg/dL) for glycemic excursions following two types of standardized meals and three dose ranges (optimum dose and +/- 30%).
Time frame: 12-14 hours
Insulin levels
To compare the pharmacokinetics of insulin absorption as well as the intra-subject variability for each delivery routes.
Time frame: 12-14 hours
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Becton, Dickinson and Company