NCT00286962

Brief Summary

The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

2.2 years

First QC Date

February 3, 2006

Last Update Submit

April 10, 2008

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes mellitus, type 1insulin infusion systemscontinuous intraperitoneal insulin infusioncross-over studies

Outcome Measures

Primary Outcomes (1)

  • incidence of hypoglycemia; data taken from patient diaries during either study arm.

Secondary Outcomes (7)

  • glycemic control; glycosylated hemoglobin (HbA1c) measurement at baseline, end of entry phase, start of both study arms, halfway through study arms, end of study arms.

  • average daily insulin usage; as taken from patient diaries for both study arms

  • frequency of adverse events; as taken from patient diaries for both study arms

  • frequency of clinically significant abnormal laboratory values and device complications; as taken from patient diaries for both study arms

  • Quality of life; score on a quality of life scale at baseline and end of either study arm

  • +2 more secondary outcomes

Study Arms (2)

CIPII

EXPERIMENTAL

Intraperitoneal insulin infusion by means of an implanted insulin pump

Device: MIP 2007C implantable insulin pump

CSII/ MDI

ACTIVE COMPARATOR

Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI)

Device: continuous subcutaneous insulin infusion (CSII) or MDI

Interventions

MIP 2007C implantable insulin pumpDEVICE

Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c

CIPII
continuous subcutaneous insulin infusion (CSII) or MDIDEVICE
CSII/ MDI

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes mellitus
  • Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week.

You may not qualify if:

  • renal function impairment: creatinin ≥ 150 micromol/L or a creatinin clearance \< 50 ml/min
  • Cardiac problems: decompensated heart failure (NYHA III and IV); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months
  • Known or suspected allergy against insulin or any component of the composition
  • Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
  • Severe untreated proliferative retinopathy.
  • Insufficient knowledge of the Dutch language to understand the requirements of the study.
  • Current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year.
  • Substance abuse, other than nicotine
  • A history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma
  • Participation in other trials, involving investigational products within 30 days prior to trial entry.
  • Plans to engage in activities which require them to go below 25 feet below sea level.
  • Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Klinieken

Zwolle, 8000 GM, Netherlands

Location

Related Publications (1)

  • Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Gans RO, Bilo HJ. Health-related quality of life, treatment satisfaction, and costs associated with intraperitoneal versus subcutaneous insulin administration in type 1 diabetes: a randomized controlled trial. Diabetes Care. 2010 Jun;33(6):1169-72. doi: 10.2337/dc09-1758. Epub 2010 Feb 25.

    PMID: 20185731DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Henk J Bilo, MD, PhD

    Isala Clinics, medical research foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

February 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

NL(1)