Type 1 Diabetes Mellitus Clinical Trial
Official title:
Intraperitoneal Insulin Administration as Alternative for Intensive Subcutaneous Insulin Therapy in Patients With Type 1 Diabetes Mellitus.
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.
n/a
Time Perspective: Prospective
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