Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

— IPvsSC  

Official title:

Intraperitoneal Insulin Administration as Alternative for Intensive Subcutaneous Insulin Therapy in Patients With Type 1 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621308
• Other study ID #: IPvsSC
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: March 18, 2014
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT01623999

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Diaconessenhuis Hospital	Meppel	Drenthe
Netherlands	Isala clinics	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Gans RO, van Ballegooie E, Bilo HJ. Improved glycemic control with intraperitoneal versus subcutaneous insulin in type 1 diabetes: a randomized controlled trial. Diabetes Care. 2009 Aug;32(8):1372-7. doi: 10.2337/dc08-2340. Epub 2009 May 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycaemic regulation	HbA1c (mmol/mol)	6 months	No
Secondary	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	No
Secondary	Hypoglycaemic episodes		6 months	No
Secondary	Concentrations of IGF-1 and IGFBP		6 months	No
Secondary	Total daily insulin dose.		6 months	No
Secondary	Lipid spectrum		6 months	No
Secondary	Health related quality of life		6 months	No
Secondary	Diabetes related quality of life		6 months	No
Secondary	Diabetes related distress		6 months	No
Secondary	Diabetes related self care		6 months	No
Secondary	Treatment satisfaction		6 months	No
Secondary	body mass index		6 months	No
Secondary	Blood pressure		6 months	No
Secondary	Microvascular complications of diabetes		6 months	No
Secondary	Macrovascular complications of diabetes		6 months	No