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NCT Number: NCT01621308

Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diaconessenhuis Hospital, Meppel, Drenthe, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mode of insulin administration

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.

Primary outcomes

  1. glycaemic regulation

    Time frame: 6 months

    HbA1c (mmol/mol)

Secondary outcomes

  1. 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

  2. Hypoglycaemic episodes

    Time frame: 6 months

  3. Concentrations of IGF-1 and IGFBP

    Time frame: 6 months

  4. Total daily insulin dose.

    Time frame: 6 months

  5. Lipid spectrum

    Time frame: 6 months

  6. Health related quality of life

    Time frame: 6 months

  7. Diabetes related quality of life

    Time frame: 6 months

  8. Diabetes related distress

    Time frame: 6 months

  9. Diabetes related self care

    Time frame: 6 months

  10. Treatment satisfaction

    Time frame: 6 months

  11. body mass index

    Time frame: 6 months

  12. Blood pressure

    Time frame: 6 months

  13. Microvascular complications of diabetes

    Time frame: 6 months

  14. Macrovascular complications of diabetes

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical Research Foundation, The Netherlands

Other

Registry information

Official study title

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

Acronym: IPvsSC

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 18, 2012
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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