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
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