Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

NCT ID: NCT01621308

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 190 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-03-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

IP insulin

Patients treated with continuous intraperitoneal insulin infusion using a implantable pump

Mode of insulin administration

Intervention Type: OTHER

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.

SC insulin

Patients treated with subcutaneous insulin, both multiple daily injections and continuous subcutaneous insulin infusion

Mode of insulin administration

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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.

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Foundation, The Netherlands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henk JG Bilo, MD PhD FRCP

Role: STUDY_CHAIR

Isala clinics, Diabetes centre

Peter R Dijk, M.D.

Role: PRINCIPAL_INVESTIGATOR

Isala clinics, Diabetes centre

N Kleefstra, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Isala clinics, Diabetes centre

S JJ Logtenberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of internal medicine

Klaas H Groenier, PhD

Role: PRINCIPAL_INVESTIGATOR

Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of primary medicine

Locations

Diaconessenhuis Hospital

Meppel, Drenthe, Netherlands

Isala clinics

Zwolle, Overijssel, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 19429874 (View on PubMed)

van Dijk PR, Logtenberg SJ, Chisalita SI, Hedman CA, Groenier KH, Gans RO, Kleefstra N, Arnqvist HJ, Bilo HJ. Different Effects of Intraperitoneal and Subcutaneous Insulin Administration on the GH-IGF-1 Axis in Type 1 Diabetes. J Clin Endocrinol Metab. 2016 Jun;101(6):2493-501. doi: 10.1210/jc.2016-1473. Epub 2016 Apr 26.

Reference Type: DERIVED

PMID: 27115061 (View on PubMed)

van Dijk PR, Logtenberg SJ, Hendriks SH, Groenier KH, Feenstra J, Pouwer F, Gans RO, Kleefstra N, Bilo HJ. Intraperitoneal versus subcutaneous insulin therapy in the treatment of type 1 diabetes mellitus. Neth J Med. 2015 Nov;73(9):399-409.

Reference Type: DERIVED

PMID: 26582805 (View on PubMed)

Other Identifiers

IPvsSC

Identifier Type: -

Identifier Source: org_study_id

NCT01623999

Identifier Type: -

Identifier Source: nct_alias