Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Mode of insulin administration

• 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

Study Timeline

• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Study Start: 2012-12
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IP insulin	Mode of insulin administration	Patients treated with continuous intraperitoneal insulin infusion using a implantable pump
SC insulin	Mode of insulin administration	Patients treated with subcutaneous insulin, both multiple daily injections and continuous subcutaneous insulin infusion

Primary Outcome Measures

Name	Time	Method
glycaemic regulation	6 months	HbA1c (mmol/mol)

Secondary Outcome Measures

Name	Time	Method
body mass index	6 months
Blood pressure	6 months
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

Trial Locations

Locations (2)

Diaconessenhuis Hospital; 🇳🇱 Meppel, Drenthe, Netherlands

Isala clinics; 🇳🇱 Zwolle, Overijssel, Netherlands