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Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

Information source: Medical Research Foundation, The Netherlands
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: Mode of insulin administration (Other)

Phase: N/A

Status: Completed

Sponsored by: Medical Research Foundation, The Netherlands

Official(s) and/or principal investigator(s):
Henk JG Bilo, MD PhD FRCP, Study Chair, Affiliation: Isala clinics, Diabetes centre
Peter R Dijk, M.D., Principal Investigator, Affiliation: Isala clinics, Diabetes centre
N Kleefstra, M.D. PhD, Principal Investigator, Affiliation: Isala clinics, Diabetes centre
S JJ Logtenberg, MD PhD, Principal Investigator, Affiliation: Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of internal medicine
Klaas H Groenier, PhD, Principal Investigator, Affiliation: Isala clinics, Diabetes centre; University Medical Centre Groningen dept. of primary medicine

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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: glycaemic regulation

Secondary outcome:

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).

Hypoglycaemic episodes

Concentrations of IGF-1 and IGFBP

Total daily insulin dose.

Lipid spectrum

Health related quality of life

Diabetes related quality of life

Diabetes related distress

Diabetes related self care

Treatment satisfaction

body mass index

Blood pressure

Microvascular complications of diabetes

Macrovascular complications of diabetes

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Diaconessenhuis Hospital, Meppel, Drenthe, Netherlands

Isala clinics, Zwolle, Overijssel 8000GK, Netherlands

Additional Information

Related 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.

Starting date: December 2012
Last updated: March 18, 2014

Page last updated: August 23, 2015

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