Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
Intraperitoneal vs Subcutaneous Insulin Administration in 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.
Case inclusion criteria

 -  T1DM

 -  If subjects are on CIPII, they must be included in (8) or

 -  If subjects are on CIPII, and didn't participate in (8), they must been on CIPII at
 start of the previous study (8)

 -  If subjects are on CIPII, they must been on CIPII for the past 4 years without
 interruptions (>30 days)

 -  Proper knowledge of the Dutch language.

 Case exclusion criteria

 -  Impaired renal function (plasma creatinine ≥150 µmol/L or glomerular filtration rate
 as estimated by the Cockcroft-Gault formula ≤50ml/min)

 -  Cardiac problems (unstable angina or myocardial infarction within the previous 12
 months or New York Heart Association class III or IV congestive heart failure

 -  Mentally handicapped

 -  Current or past psychiatric treatment for schizophrenia

 -  Cognitive or bipolar disorder

 -  Current use or oral corticosteroids or suffering from a condition which necessitated
 oral or systemic corticosteroids use more than once in the previous 12 months

 -  Substance abuse, other than nicotine

 -  Current gravidity or plans to become pregnant during the trial

 -  Plans to engage in activities that require going >25 feet below sea level

 -  Any condition that the investigator and/or coordinating investigator feels would
 interfere with trial participation or evaluation of results.

 4.4 Control inclusion criteria

 -  T1DM

 -  SC insulin as mode of insulin administration

 -  If subjects are on SC insulin, they must been on SC insulin for the past 4 years
 without interruption (>30 days)

 -  HbA1c at time of matching must be ≥7.0% (53mmol/mol)

 -  Proper knowledge of the Dutch language.

 Control exclusion criteria

 -  Impaired renal function (plasma creatinine ≥150 µmol/L or glomerular filtration rate
 as estimated by the Cockcroft-Gault formula ≤50ml/min)

 -  Cardiac problems (unstable angina or myocardial infarction within the previous 12
 months or New York Heart Association class III or IV congestive heart failure

 -  Mentally handicapped

 -  Current or past psychiatric treatment for schizophrenia

 -  Cognitive or bipolar disorder

 -  Current use or oral corticosteroids or suffering from a condition which necessitated
 oral or systemic corticosteroids use more than once in the previous 12 months

 -  Substance abuse, other than nicotine

 -  Current gravidity or plans to become pregnant during the trial

 -  Plans to engage in activities that require going >25 feet below sea level

 -  Any condition that the investigator and/or coordinating investigator feels would
 interfere with trial participation or evaluation of results.