Multi-day (3) In-patient Evaluation of Intradermal Versus Subcutaneous Basal and Bolus Insulin Infusion

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Device: Intradermal delivery via the BD Research Catheter Set; Device: Subcutaneous delivery via Medtronic Quick-Set

• Registration Number: NCT01557907
• Lead Sponsor: Becton, Dickinson and Company

Brief Summary

The primary objective of this study is to investigate if intradermal (in the skin) basal and bolus insulin delivery of a fast acting insulin analog (NovoRapid) as needed to adequately control the blood glucose for a subject with Type 1 Diabetes can be maintained for a period of up to three days and if intradermal delivery of insulin has advantages over standard subcutaneous (under the skin) delivery.

Detailed Description

The is a single center, open-label, 2 period crossover study randomized by route (intradermal versus subcutaneous) in patients with Type 1 diabetes. Subjects will receive their insulin, basal and bolus dosages, via intradermal (ID) and subcutaneous (SC) infusion sets over a three day period.

Each subject will participate in 3 visits: a Screening Visit (V1), followed by 2 experimental intervention days (V2 and V3) to be started 2 - 21 days after screening visit. The minimum/maximum interval between study days shall be 5 to 28 days. Each subject will remain in the clinic for approximately 3 days during the experimental interventions. A final exam will be performed at the end of Visit 3.

After successful screening and enrollment subjects are admitted to the clinic. Their insulin pump and infusion set is replaced by the investigational system, a commercially available insulin pump and either the intradermal infusion set (Research Catheter Set, BD) or the subcutaneous infusion set (Quick Set, Medtronic)to include an in-line pressure transducer/recorder and insulin NovoRapid. The initial pump infusion rate is established based on the patient's known basal infusion rate and the meal bolus insulin is estimated based on the patient's known insulin sensitivity. An intravenous (in the vein) catheter line is established, blood glucose is measured at least every 2 hours overnight and insulin corrections can be implemented, if deemed necessary. The overnight and pre-prandial (before meal) target range is 70-160 mg/dl, although the procedure will continue as planned if the patient is outside the range. It should be the goal not to give any IV glucose or insulin at all, and not to change basal insulin settings for at least 2 hours before the meal. The breakfast meal will be a high GI (60g carbohydrates) solid meal, to be consumed within 15 minutes and followed for a period of 6 hours of blood sampling for glucose and insulin levels. Lunch will be served as standardized mixed meal, and followed for a period of 4-6 hours. This procedure is repeated on days 2 and 3 whereas the breakfast and lunch meal as well as the insulin dose to cover the meal are the same. A light evening dinner is served every day, composition and insulin dose to be recorded. On day three after the 4 hour period following lunch the catheter will be removed, catheter and site assessments will be documented and an ultrasound observation of the infusion site (skin thickness and SC) versus an adjacent control site will be performed within 10 min after removal of the infusion set. Glucose rescue, if necessary, will be administered orally (juice, 200 mL). Insulin correction boli should be delivered via the investigational infusion set.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-20
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intradermal - BD Research Catheter Set	Intradermal delivery via the BD Research Catheter Set	Intradermal delivery of insulin (basal and bolus delivery) using the BD Research Catheter Set with 34G x 1.5 mm side-ported needle and the Animas Vibe insulin pump over a three day period.
Subcutaneous - Medtronic Quick-Set	Subcutaneous delivery via Medtronic Quick-Set	Subcutaneous delivery of insulin (basal and bolus delivery) using the Medtronic Quick Set with 6 mm Teflon catheter and the Animas Vibe insulin pump over a three day period.

Primary Outcome Measures

Name	Time	Method
Insulin levels	0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days	Time to peak plasma concentration (Tmax) of insulin delivered intradermally as compared to insulin delivered subcutaneously after a meal bolus.

Secondary Outcome Measures

Name	Time	Method
Skin effects-Draize Scoring for Skin Irritation	Following removal of the device (within 2 minutes) and 1 and 2 hours (+/- 5 minutes) post removal.	Local reaction at injection site will be scored using the Draize Scale 0-4 for redness and 0-4 for swelling.
Insulin levels	0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days	Comparison of peak plasma concentration (Cmax) of insulin, intradermally versus subcutaneously, during a meal bolus period.; Comparison of area under the plasma concentration versus time curve (AUC), intradermally versus subcutanously, during a meal bolus period.
Blood Glucose	0,10,15,20,25,30,35,40,45,50,55,60,65,70,80,90,120,150,180,210,240,300,330,345,360 minutes following each breakfast and lunch meal bolus for the 3 study days	Peak concentration of blood glucose (BGmax) during post meal excursions periods.; Area under the plasma concentration versus time curve (AUC) of blood glucose during post meal excurion periods.
Device performance - adhesion	Evaluated at every timepoint a bolus injection is given	Adhesion (device remains attached to the skin) will be evaluated over the 3 day study period (adhered well, partially adhered, completely pulled off).
Skin thickness using ultrasound	Upon removal of the device (within 5 minutes)	Skin thickness will be measured at the infusion site and a control site using ultrasound
Device performance - Leakage of fluid (insulin) at injection site	Immediatley before and after each bolus injection and immediatly upon removal of the device at the end of the study period.	Immediatley before and after each bolus injection, the site will be observed for leakage (insulin). In addition, following removal of the device, if leakakge is observed, the fluid will be collected and quantified using a gravimetic method procedure. Leakage will be collected using a pre-weighed sterile absorbent swab, the swab will be re-weighed and the collected fuid volume calculated based on the density of the fluid.
Device performance-pump alarm	over the 3 study days	The presence of an auditory alarm indicating an occlusion will be noted.
Number of participants with adverse events	up to 53 days or until the subject is discharged, if sooner.	At each study contact, subjects will be questioned about any new or worsening undesirable events.

Trial Locations

Locations (1)

Profil Institut fur Stoffwechselfforschung GmbH; 🇩🇪 Neuss, Germany