Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT01621308
- Lead Sponsor
- Medical Research Foundation, The Netherlands
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method glycaemic regulation 6 months HbA1c (mmol/mol)
- Secondary Outcome Measures
Name Time Method Diabetes related distress 6 months Percentage time spent in hypo/hyper- and euglycaemia during a 3-7 day 24-hour blood glucose profile using a continuous glucose measurement system (CGMS). 6 months Hypoglycaemic episodes 6 months Concentrations of IGF-1 and IGFBP 6 months Total daily insulin dose. 6 months Lipid spectrum 6 months Health related quality of life 6 months Diabetes related quality of life 6 months Diabetes related self care 6 months Treatment satisfaction 6 months Microvascular complications of diabetes 6 months Macrovascular complications of diabetes 6 months body mass index 6 months Blood pressure 6 months
Trial Locations
- Locations (2)
Diaconessenhuis Hospital
🇳🇱Meppel, Drenthe, Netherlands
Isala clinics
🇳🇱Zwolle, Overijssel, Netherlands
Diaconessenhuis Hospital🇳🇱Meppel, Drenthe, Netherlands