Diabetes MellitusIRCATTNCT03298295
Inflammatory Response to CSII Catheters in a Tummy Tuck Model
A study testing Continous Subcutaneous Insulin Infusion Catheter in people with Diabetes Mellitus, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Continous Subcutaneous Insulin Infusion Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Plastic, Aesthetic and Reconstructive Surgery
Graz, 8036
About this study
Official title: A Pilot Study for the Systematic Evaluation of the Inflammatory Response to Commercially Available Insulin Infusion Catheters in Subcutaneous Adipose Tissue
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.
Read the detailed description
Background:
Approximately one million patients worldwide manage their diabetes with an insulin pump. Insulin is continuously infused into the subcutaneous adipose tissue via a Continuous Subcutaneous Insulin Infusion (CSII) catheter using a basal/bolus pattern that can be adjusted by the patient according to meal times, mimicking the natural function of the pancreas. One major advantage of this form of therapy is the improvement of living quality. Compared to multiple daily insulin injections, the catheter has to be inserted only once every 2-3 days where it remains within the subcutaneous tissue. This is especially advantageous for children of young age.
Unfortunately, insulin absorption from the tissue surrounding a CSII catheter can be slow, variable, and unreliable. It is recommended to replace infusion sets and CSII catheters after 2 to 3 days of clinical use. After this time, blood glucose control becomes difficult for the patient because insulin absorption from the subcutaneous tissue into the blood stream and lymphatics becomes highly variable.
The underlying mechanisms for impaired insulin absorption are poorly understood and the knowledge of rotating the site of injection is based on user experience. 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. In order to develop CSII catheters with an extended life-time up to 7 days, there is a need to better understand the inflammatory response caused by the introduction and maintenance of a CSII catheter into the subcutaneous adipose tissue. The clinical use of a 7-day CSII catheter with low pharmacokinetics (PK) variability will significantly improve blood glucose control, decrease the risk for hypoglycemia, increase compliance, and decrease cost. Since continuous glucose monitoring (CGM) devices are approved for 7-day wear time, the development of a CSII catheter with extended lifetime is also crucial for the development of single-port artificial pancreas (AP) systems where CSII and CGM are combined in one catheter, mimicking pancreatic function. Furthermore, the improvement of catheter longevity will reduce insertion sites and scars. This is especially important for children with a smaller body surface area.
The choice of one material over the other is largely based on the patient's personal preference, his or her endocrinologist's or diabetes educator's opinion and therapy costs. There is a trend in both the United States and Europe towards using Teflon sets (90 % and 75 %, respectively) but approximately 40 to 45 % of pump users in Germany use steel catheters. Compared to Teflon, steel catheters are easier to insert and are less prone to kinking, and can be worn by patients allergic to Teflon. Patients using steel catheters report better metabolic control, less variable insulin absorption and less unexplained hyperglycemia (Heinemann 2016; Reichert et al. 2013). However, especially during exercise, steel may cause discomfort and the softer and more flexible Teflon catheter is assumed to be more comfortable to wear. The wear-time of the CSII catheter considerably varies between patients (from 2 to 10 days), although recommendations for the optimal frequency of changing an insulin infusion set (2 days for steel and 3 days for Teflon) exist.
In a prior pig study the inflammatory response to commercial CSII catheters comparing steel, Teflon and Teflon with an anti-inflammatory coating was analyzed. There was significant reduction in area of inflammation and macrophage recruitment around the non-coated and coated Teflon catheters. Steel elicited the most severe inflammatory response with significantly higher fibrosis.
Although the pig has proven to be an excellent model for the study of human skin and adipose tissue, there is an urgent medical need to confirm these findings in a human model. For the histopathological and molecular analysis of subcutaneous tissue in the vicinity of the catheter, large amounts of tissue need to be excised from the site of interest. This makes a human study almost impossible. Nevertheless, the generation of human data is crucial and a lot of this important information is still lacking in diabetes research and treatment. The possibility to excise extensive amounts of tissue without causing additional scars or pain (except that caused by the abdominoplasty itself) for the patient presents the main benefit of this study setup.
Aim:
The aim of this study is to compare the inflammatory response to commercially available CSII catheters of two different materials (steel and Teflon) over 1 day, 4 days and 7 days of wear-time in humans scheduled for elective plastic surgery (abdominoplasty).
Hypothesis:
Conventional steel CSII catheters elicit a more severe acute inflammatory response in the subcutaneous adipose tissue than Teflon CSII catheters.
H0 = there is no difference in mean area of fibrin deposition around catheters H1 = there is a significant difference in mean area of fibrin deposition between catheters
- Conditions
- Diabetes Mellitus
- Being tested
- Continous Subcutaneous Insulin Infusion Catheter
- Keywords
- Diabetes Mellitus, Insulin Pump Therapy, Continuous Subcutaneous Insulin Infusion
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous Subcutaneous Insulin Infusion CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continous Subcutaneous Insulin Infusion Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of inflammation (mm2)
Assessed by microscopy; area of inflamed tissue, including cell infiltration, necrosis, fibrin/collagen deposition
Measured: 7 days
Secondary outcomes (5)
Area of fibrin deposition (mm2)
Assessed by microscopy; area of fibrin
Measured: 7 days
Area of fat necrosis (mm2)
assessed by microscopy; area of necrosed adipocytes
Measured: 7 days
Inflammation distance (mm)
assessed by microscopy; distance from skin surface to lowest point of microscopically assessed inflammation
Measured: 7 days
Cytokine gene expression (fold change)
Assessed by qPCR; relative fold change in gene expression compared to non-traumatized tissue (IL-1b, TNFa, TGFb, IL-6, IL-8, IL-10)
Measured: 7 days
Macrophage marker gene expression (fold change)
Assessed by qPCR; relative fold change in CD68 gene expression compared to non-traumatized tissue
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Feb 2018
- Primary completion9 May 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-diabetic patients scheduled for selective plastic surgery (abdominoplasty).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars-Peter Kamolz, MD Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298295
- Sponsor's protocol ID
- IRCATT
- Acronym
- IRCATT
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2017
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Conwell LS, Pope E, Artiles AM, Mohanta A, Daneman A, Daneman D. Dermatological complications of continuous subcutaneous insulin infusion in children and adolescents. J Pediatr. 2008 May;152(5):622-8. doi: 10.1016/j.jpeds.2007.10.006. Epub 2008 Jan 22.
PubMed 18410763Deiss D, Adolfsson P, Alkemade-van Zomeren M, Bolli GB, Charpentier G, Cobelli C, Danne T, Girelli A, Mueller H, Verderese CA, Renard E. Insulin Infusion Set Use: European Perspectives and Recommendations. Diabetes Technol Ther. 2016 Sep;18(9):517-24. doi: 10.1089/dia.2016.07281.sf. Epub 2016 Aug 15.
PubMed 27526329Facchinetti 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.
PubMed 23172973Heinemann 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.
PubMed 26885764Heinemann 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.
PubMed 25776138Heinemann L. Variability of insulin absorption and insulin action. Diabetes Technol Ther. 2002;4(5):673-82. doi: 10.1089/152091502320798312.
PubMed 12450450Heinemann 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.
PubMed 22920824Heinemann 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.
PubMed 24876567Macmillan 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.
PubMed 8021539Pickup 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.
PubMed 24180294Reichert, D. et al., 2013. Realität der Insulinpumpentherapie in Diabetesschwerpunktpraxen: Daten von 1142 Patienten aus 40 diabetologischen Schwerpunktpraxen. Diabetes Stoffwechsel Herz, 22, pp.367-375.
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.
PubMed 25622214Schmid 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.
PubMed 20663464Sullivan 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.
PubMed 11350644Walsh 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.
PubMed 26071425
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Systematic Evaluation of the Inflammatory Response to Commercially Available Insulin Infusion Catheters in Subcutaneous Adipose Tissue
- ClinicalTrials.gov ID
- NCT03298295
- Acronym / sponsor ID
- IRCATT / IRCATT
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Insulin Pump Therapy, Continuous Subcutaneous Insulin Infusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Approximately one million patients worldwide manage their diabetes with an insulin pump. Insulin is continuously infused into the subcutaneous adipose tissue via a Continuous Subcutaneous Insulin Infusion (CSII) catheter using a basal/bolus pattern that can be adjusted by the patient according to meal times, mimicking the natural function of the pancreas. One major advantage of this form of therapy is the improvement of living quality. Compared to multiple daily insulin injections, the catheter has to be inserted only once every 2-3 days where it remains within the subcutaneous tissue. This is especially advantageous for children of young age.
Unfortunately, insulin absorption from the tissue surrounding a CSII catheter can be slow, variable, and unreliable. It is recommended to replace infusion sets and CSII catheters after 2 to 3 days of clinical use. After this time, blood glucose control becomes difficult for the patient because insulin absorption from the subcutaneous tissue into the blood stream and lymphatics becomes highly variable.
The underlying mechanisms for impaired insulin absorption are poorly understood and the knowledge of rotating the site of injection is based on user experience. 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. In order to develop CSII catheters with an extended life-time up to 7 days, there is a need to better understand the inflammatory response caused by the introduction and maintenance of a CSII catheter into the subcutaneous adipose tissue. The clinical use of a 7-day CSII catheter with low pharmacokinetics (PK) variability will significantly improve blood glucose control, decrease the risk for hypoglycemia, increase compliance, and decrease cost. Since continuous glucose monitoring (CGM) devices are approved for 7-day wear time, the development of a CSII catheter with extended lifetime is also crucial for the development of single-port artificial pancreas (AP) systems where CSII and CGM are combined in one catheter, mimicking pancreatic function. Furthermore, the improvement of catheter longevity will reduce insertion sites and scars. This is especially important for children with a smaller body surface area.
The choice of one material over the other is largely based on the patient's personal preference, his or her endocrinologist's or diabetes educator's opinion and therapy costs. There is a trend in both the United States and Europe towards using Teflon sets (90 % and 75 %, respectively) but approximately 40 to 45 % of pump users in Germany use steel catheters. Compared to Teflon, steel catheters are easier to insert and are less prone to kinking, and can be worn by patients allergic to Teflon. Patients using steel catheters report better metabolic control, less variable insulin absorption and less unexplained hyperglycemia (Heinemann 2016; Reichert et al. 2013). However, especially during exercise, steel may cause discomfort and the softer and more flexible Teflon catheter is assumed to be more comfortable to wear. The wear-time of the CSII catheter considerably varies between patients (from 2 to 10 days), although recommendations for the optimal frequency of changing an insulin infusion set (2 days for steel and 3 days for Teflon) exist.
In a prior pig study the inflammatory response to commercial CSII catheters comparing steel, Teflon and Teflon with an anti-inflammatory coating was analyzed. There was significant reduction in area of inflammation and macrophage recruitment around the non-coated and coated Teflon catheters. Steel elicited the most severe inflammatory response with significantly higher fibrosis.
Although the pig has proven to be an excellent model for the study of human skin and adipose tissue, there is an urgent medical need to confirm these findings in a human model. For the histopathological and molecular analysis of subcutaneous tissue in the vicinity of the catheter, large amounts of tissue need to be excised from the site of interest. This makes a human study almost impossible. Nevertheless, the generation of human data is crucial and a lot of this important information is still lacking in diabetes research and treatment. The possibility to excise extensive amounts of tissue without causing additional scars or pain (except that caused by the abdominoplasty itself) for the patient presents the main benefit of this study setup.
Aim:
The aim of this study is to compare the inflammatory response to commercially available CSII catheters of two different materials (steel and Teflon) over 1 day, 4 days and 7 days of wear-time in humans scheduled for elective plastic surgery (abdominoplasty).
Hypothesis:
Conventional steel CSII catheters elicit a more severe acute inflammatory response in the subcutaneous adipose tissue than Teflon CSII catheters.
H0 = there is no difference in mean area of fibrin deposition around catheters H1 = there is a significant difference in mean area of fibrin deposition between catheters
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-diabetic patients scheduled for selective plastic surgery (abdominoplasty).
| Arm | Type | Receives |
|---|---|---|
| Insertion of Insulin Infusion Catheters | Experimental | Device: Continous Subcutaneous Insulin Infusion CatheterNon-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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continous Subcutaneous Insulin Infusion CatheterCatheters 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. | Device | Insertion of Insulin Infusion Catheters |
Primary outcome
Area of inflammation (mm2)
Time frame: 7 days
Assessed by microscopy; area of inflamed tissue, including cell infiltration, necrosis, fibrin/collagen deposition
5 secondary outcomes
Area of fibrin deposition (mm2)
Time frame: 7 days
Area of fat necrosis (mm2)
Time frame: 7 days
Inflammation distance (mm)
Time frame: 7 days
Cytokine gene expression (fold change)
Time frame: 7 days
Macrophage marker gene expression (fold change)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 18410763Conwell LS, Pope E, Artiles AM, Mohanta A, Daneman A, Daneman D. Dermatological complications of continuous subcutaneous insulin infusion in children and adolescents. J Pediatr. 2008 May;152(5):622-8. doi: 10.1016/j.jpeds.2007.10.006. Epub 2008 Jan 22.
- Background: PubMed 27526329Deiss D, Adolfsson P, Alkemade-van Zomeren M, Bolli GB, Charpentier G, Cobelli C, Danne T, Girelli A, Mueller H, Verderese CA, Renard E. Insulin Infusion Set Use: European Perspectives and Recommendations. Diabetes Technol Ther. 2016 Sep;18(9):517-24. doi: 10.1089/dia.2016.07281.sf. Epub 2016 Aug 15.
- Background: PubMed 23172973Facchinetti 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.
- Background: PubMed 26885764Heinemann 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.
- Background: PubMed 25776138Heinemann 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.
- Background: PubMed 12450450Heinemann L. Variability of insulin absorption and insulin action. Diabetes Technol Ther. 2002;4(5):673-82. doi: 10.1089/152091502320798312.
- Background: PubMed 22920824Heinemann 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.
- Background: PubMed 24876567Heinemann 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.
- Background: PubMed 8021539Macmillan 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.
- Background: PubMed 24180294Pickup 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.
- BackgroundReichert, 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: PubMed 25622214Sampson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars-Peter Kamolz, MD Prof principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous Subcutaneous Insulin Infusion Catheter in people with Diabetes Mellitus, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of inflammation (mm2) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03298295, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.