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Type 1 Diabetes MellitusIPvsSCNCT01621308

Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

An observational study of Type 1 Diabetes Mellitus, run by Medical Research Foundation, The Netherlands at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Mode of insulin administration
Type of treatment
Injection or infusion
How many people
190 participants
Where
2 sitesNetherlands
Study dates
Dec 2012to Mar 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Diaconessenhuis Hospital

    Meppel, Drenthe

  • Isala clinics

    Zwolle, Overijssel, 8000GK

Other trials in Netherlands

About this study

Official title: Intraperitoneal Insulin Administration as Alternative for Intensive Subcutaneous Insulin Therapy in Patients With 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.

Read more

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.

Being tested
Mode of insulin administration
Keywords
Diabetes Mellitus type 1, Intraperitoneal insulin administration, Subcutaneous insulin administration, Continuous intraperitoneal insulin infusion
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mode of insulin administrationOther

    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.

Study groups in NCT01621308
Study groupRoleWhat they receive
IP insulinPatients treated with continuous intraperitoneal insulin infusion using a implantable pump
Receives: Other: Mode of insulin administration
SC insulinPatients treated with subcutaneous insulin, both multiple daily injections and continuous subcutaneous insulin infusion
Receives: Other: Mode of insulin administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. glycaemic regulation

    HbA1c (mmol/mol)

    Measured: 6 months

Secondary outcomes (14)

  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).

    Measured: 6 months

  2. Hypoglycaemic episodes

    Measured: 6 months

  3. Concentrations of IGF-1 and IGFBP

    Measured: 6 months

  4. Total daily insulin dose.

    Measured: 6 months

  5. Lipid spectrum

    Measured: 6 months

  6. Health related quality of life

    Measured: 6 months

  7. Diabetes related quality of life

    Measured: 6 months

  8. Diabetes related distress

    Measured: 6 months

  9. Diabetes related self care

    Measured: 6 months

  10. Treatment satisfaction

    Measured: 6 months

  11. body mass index

    Measured: 6 months

  12. Blood pressure

    Measured: 6 months

  13. Microvascular complications of diabetes

    Measured: 6 months

  14. Macrovascular complications of diabetes

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
190 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01621308
Sponsor's protocol ID
IPvsSC
Acronym
IPvsSC
Status last verified
Mar 2014
First submitted
14 Jun 2012
Last updated
19 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19429874

  • 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.

    PubMed 27115061

  • 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.

    PubMed 26582805

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes Mellitus, run by Medical Research Foundation, The Netherlands at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

glycaemic regulation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01621308, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.

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