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Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

NCT01621308 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2014-03-19

No results posted yet for this study

Summary

Almost all patients with type 1 diabetes mellitus (T1DM) need insulin treatment permanently. For selected patients who are unable to achieve glycaemic targets with subcutaneous (SC) insulin treatment, continuous intraperitoneal (IP) insulin infusion is an third-line alternative.

Previous studies demonstrate that continuous intraperitoneal insulin infusion (CIPII) using an implantable pump device improves glycaemic control and quality of life in patients with 'brittle' T1DM. Nevertheless, literature comparing IP and SC insulin treatment is scarce.

The primary objective of this study is to compare the effects of IP insulin delivery to SC insulin delivery.The null hypothesis (H0) of the current study holds inferiority of CIPII compared to SC insulin regarding long-term glycaemic control. The alternative hypothesis (H1) is the inverse: CIPII is non-inferior to SC insulin. In summary, H0: CIPII is inferior to the SC insulin treatment H1: CIPII is not inferior to SC insulin treatment

This is an investigator initiated, open label and prospective matched-control study with a non-inferiority design. The trial duration is 36 weeks and is conducted in a single-centre (Isala Clinics, Zwolle). If non-inferiority is established superiority analyses are performed.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

OTHER

Mode of insulin administration

There are no interventions in this observational study. Both treatment groups continue the mode of therapy the patient had before the start of the present study: continuous intraperitoneal insulin infusion with an implantable pump (MIP2007D) or subcutaneous insulin administration with multiple daily injections or continuous subcutaneous insulin infusion.

Sponsors & Collaborators

  • Medical Research Foundation, The Netherlands

    lead OTHER

Principal Investigators

  • Henk JG Bilo, MD PhD FRCP · Isala clinics, Diabetes centre

  • Peter R Dijk, M.D. · Isala clinics, Diabetes centre

  • N Kleefstra, M.D. PhD · Isala clinics, Diabetes centre

  • S JJ Logtenberg, MD PhD · Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of internal medicine

  • Klaas H Groenier, PhD · Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of primary medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621308 on ClinicalTrials.gov