Inflammatory Response to CSII Catheters in a Tummy Tuck Model

NCT03298295 | Completed

• 1 other identifier: IRCATT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In insulin pump therapy, insulin is continuously infused into the subcutaneous adipose tissue via a continuous subcutaneous insulin infusion (CSII) catheter using a basal/bolus pattern. Unfortunately, insulin absorption from the tissue surrounding a CSII catheter can be slow, variable, and unreliable. It is recommended to replace CSII catheters after 2 to 3 days of use. Frequently changing the injection site can be tedious and moreover leads to scarring, while reusing the same injection site can lead to medical complications such as lipohypertrophy. CSII catheters are manufactured from both steel and Teflon and use of either of these materials is based on personal preference/experience rather than scientific, empirical data. We hypothesize that the inflammatory response to CSII catheters is a major contributor to variable insulin absorption and that this response is significantly different between materials and catheters shapes. In order to develop CSII catheters with an extended life-time up to 7 days, we need to better understand the inflammatory response caused by the introduction and maintenance of a CSII catheter into the subcutaneous adipose tissue. This study is a pilot study in humans scheduled for elective plastic surgery where a large skin flap is removed from the abdominal region. Teflon and steel CSII catheters will be inserted into the abdomen 7, 4, and 3 days prior to surgery. This study design allows for the removal of tissue plugs surrounding CSII catheters without causing additional scarring for the patient.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Insulin Pump Therapy; Continuous Subcutaneous Insulin Infusion

Outcome Measures

Primary Outcomes (1)

• Area of inflammation (mm2)

  Assessed by microscopy; area of inflamed tissue, including cell infiltration, necrosis, fibrin/collagen deposition

  7 days

Secondary Outcomes (5)

• Area of fibrin deposition (mm2)

  7 days

• Area of fat necrosis (mm2)

  7 days

• Inflammation distance (mm)

  7 days

• Cytokine gene expression (fold change)

  7 days

• Macrophage marker gene expression (fold change)

  7 days

Study Arms (1)

Insertion of Insulin Infusion Catheters

EXPERIMENTAL

Non-diabetic patients scheduled for abdominoplasty will be inserted continuous subcutaneous insulin infusion (CSII) catheters of two different materials into the part of the abdomen which will be removed during surgery.

Device: Continous Subcutaneous Insulin Infusion Catheter

Interventions

Continous Subcutaneous Insulin Infusion Catheter DEVICE

Catheters will be inserted into the abdomen of each patient using aseptic technique according to the following schedule: (1) 8 days before surgery, (2) 4 days before surgery and (3) 1 day before surgery (Table 1). At each time point 2 steel (Medtronic Sure-T, 9 mm) and 2 Teflon (Medtronic Quick-set®, 9 mm) CSII catheters will be inserted into the subcutaneous abdominal tissue. In total, 12 catheters will be inserted into each patient's abdomen using only the area predefined by the plastic surgeon for removal.

Insertion of Insulin Infusion Catheters

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 18 years or older
• Scheduled elective abdominoplasty at the Dpt. of Plastic Surgery, Medical University of Graz
• Signed informed consent form

You may not qualify if:

• Allergy to Teflon or steel
• Known skin diseases (atopic dermatitis, psoriasis)
• History of immunodeficiency diseases
• Patients on glucocorticoid or other immunomodulating therapy
• History of bleeding disorder
• Pregnancy or planned pregnancy
• Unable to fully understand study procedures and to provide informed consent

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Division of Plastic, Aesthetic and Reconstructive Surgery

Graz, 8036, Austria

Location

Related Publications (15)

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  PMID: 18410763 BACKGROUND

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  PMID: 27526329 BACKGROUND

• Facchinetti A, Sparacino G, Guerra S, Luijf YM, DeVries JH, Mader JK, Ellmerer M, Benesch C, Heinemann L, Bruttomesso D, Avogaro A, Cobelli C; AP@home Consortium. Real-time improvement of continuous glucose monitoring accuracy: the smart sensor concept. Diabetes Care. 2013 Apr;36(4):793-800. doi: 10.2337/dc12-0736. Epub 2012 Nov 19.

  PMID: 23172973 BACKGROUND

• Heinemann L. Insulin Infusion Sets: A Critical Reappraisal. Diabetes Technol Ther. 2016 May;18(5):327-33. doi: 10.1089/dia.2016.0013. Epub 2016 Feb 17.

  PMID: 26885764 BACKGROUND

• Heinemann L, Fleming GA, Petrie JR, Holl RW, Bergenstal RM, Peters AL. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Diabetes Care. 2015 Apr;38(4):716-22. doi: 10.2337/dc15-0168.

  PMID: 25776138 BACKGROUND

• Heinemann L. Variability of insulin absorption and insulin action. Diabetes Technol Ther. 2002;4(5):673-82. doi: 10.1089/152091502320798312.

  PMID: 12450450 BACKGROUND

• Heinemann L, Krinelke L. Insulin infusion set: the Achilles heel of continuous subcutaneous insulin infusion. J Diabetes Sci Technol. 2012 Jul 1;6(4):954-64. doi: 10.1177/193229681200600429.

  PMID: 22920824 BACKGROUND

• Heinemann L, Walsh J, Roberts R. We Need More Research and Better Designs for Insulin Infusion Sets. J Diabetes Sci Technol. 2014 Mar;8(2):199-202. doi: 10.1177/1932296814523882. Epub 2014 Feb 27. No abstract available.

  PMID: 24876567 BACKGROUND

• Macmillan K, Bruera E, Kuehn N, Selmser P, Macmillan A. A prospective comparison study between a butterfly needle and a Teflon cannula for subcutaneous narcotic administration. J Pain Symptom Manage. 1994 Feb;9(2):82-4. doi: 10.1016/0885-3924(94)90160-0.

  PMID: 8021539 BACKGROUND

• Pickup JC, Yemane N, Brackenridge A, Pender S. Nonmetabolic complications of continuous subcutaneous insulin infusion: a patient survey. Diabetes Technol Ther. 2014 Mar;16(3):145-9. doi: 10.1089/dia.2013.0192. Epub 2013 Nov 1.

  PMID: 24180294 BACKGROUND

• Reichert, D. et al., 2013. Realität der Insulinpumpentherapie in Diabetesschwerpunktpraxen: Daten von 1142 Patienten aus 40 diabetologischen Schwerpunktpraxen. Diabetes Stoffwechsel Herz, 22, pp.367-375.

  BACKGROUND

• Sampson Perrin AJ, Guzzetta RC, Miller KM, Foster NC, Lee A, Lee JM, Block JM, Beck RW; T1D Exchange Clinic Network. A web-based study of the relationship of duration of insulin pump infusion set use and fasting blood glucose level in adults with type 1 diabetes. Diabetes Technol Ther. 2015 May;17(5):307-10. doi: 10.1089/dia.2014.0336. Epub 2015 Jan 26.

  PMID: 25622214 BACKGROUND

• Schmid V, Hohberg C, Borchert M, Forst T, Pfutzner A. Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol. 2010 Jul 1;4(4):976-82. doi: 10.1177/193229681000400429.

  PMID: 20663464 BACKGROUND

• Sullivan TP, Eaglstein WH, Davis SC, Mertz P. The pig as a model for human wound healing. Wound Repair Regen. 2001 Mar-Apr;9(2):66-76. doi: 10.1046/j.1524-475x.2001.00066.x.

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• Walsh J, Roberts R, Weber D, Faber-Heinemann G, Heinemann L. Insulin Pump and CGM Usage in the United States and Germany: Results of a Real-World Survey With 985 Subjects. J Diabetes Sci Technol. 2015 Jun 12;9(5):1103-10. doi: 10.1177/1932296815588945.

  PMID: 26071425 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lars-Peter Kamolz, MD Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The only person blinded in this study is the pathologist analyzing the tissue sections.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-diabetic patients scheduled for selective plastic surgery (abdominoplasty).

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 2, 2017
• Study Start: February 1, 2018
• Primary Completion: May 9, 2023
• Study Completion: December 31, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

AU (1)