Multi-day (3) In-patient Evaluation of Intradermal Versus Subcutaneous Basal and Bolus Insulin Infusion
Condition: Diabetes
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Subcutaneous delivery via Medtronic Quick-Set; Intradermal delivery via the BD Research Catheter Set
Intervention type(s): Device; Device
Intervention description(s): Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.; Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.
Other intervention name(s): insulin infusion set; microneedles; insulin infusion set
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetes Mellitus; Type 1 diabetes; Insulin Pump users; Intradermal insulin