Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus (IPvsSC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT01621308
First received: June 14, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Other: Mode of insulin administration

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Intraperitoneal Insulin Administration as Alternative for Intensive Subcutaneous Insulin Therapy in Patients With Type 1 Diabetes Mellitus.

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • glycaemic regulation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HbA1c (mmol/mol)


Secondary Outcome Measures:
  • 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). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Concentrations of IGF-1 and IGFBP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Total daily insulin dose. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lipid spectrum [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes related distress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes related self care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Microvascular complications of diabetes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Macrovascular complications of diabetes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: December 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IP insulin
Patients treated with continuous intraperitoneal insulin infusion using a implantable pump
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.
SC insulin
Patients treated with subcutaneous insulin, both multiple daily injections and continuous subcutaneous insulin infusion
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study sample consists of the subjects on CIPII, who participated in the crossover study performed by Logtenberg et al. (Diabetes Care 32:1372-1377, 2009) or subjects who already used CIPII at that moment (so, for a minimum of 4 years), and matched controls on SC insulin treatment .

The inclusion and exclusion criteria of the previous study are described in detail in (Diabetes Care 32:1372-1377, 2009). In brief, it consisted of patients with T1DM, low fasting c-peptide concentrations (<0.20 nmol/L), aged 18 to 70 years, treated with MDI or CSII and intermediate or poor glycaemic control; defined as glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mol) and/or ≥5 incidents of hypoglycaemia (< 4.0mmol/L) per week.

If subjects are on SC insulin, they must be able to 'function' as matched control for CIPII patients. The matching procedure, based on age and gender, will take place after patients are being included in the current study.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621308

Locations
Netherlands
Diaconessenhuis Hospital
Meppel, Drenthe, Netherlands
Isala clinics
Zwolle, Overijssel, Netherlands, 8000GK
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
Study Chair: Henk JG Bilo, MD PhD FRCP Isala clinics, Diabetes centre
Principal Investigator: Peter R Dijk, M.D. Isala clinics, Diabetes centre
Principal Investigator: N Kleefstra, M.D. PhD Isala clinics, Diabetes centre
Principal Investigator: S JJ Logtenberg, MD PhD Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of internal medicine
Principal Investigator: Klaas H Groenier, PhD Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of primary medicine
  More Information

Publications:
Responsible Party: Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01621308     History of Changes
Obsolete Identifiers: NCT01623999
Other Study ID Numbers: IPvsSC
Study First Received: June 14, 2012
Last Updated: March 18, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
Diabetes Mellitus type 1
Intraperitoneal insulin administration
Subcutaneous insulin administration
Continuous intraperitoneal insulin infusion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014