Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus type 1, Intraperitoneal insulin administration, Subcutaneous insulin administration, Continuous intraperitoneal insulin infusion
Brief 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.
Interventions
OTHERMode 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.
Sponsors
Medical Research Foundation, The Netherlands
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glycaemic regulation | 6 months | HbA1c (mmol/mol) |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycaemic episodes | 6 months |
| Concentrations of IGF-1 and IGFBP | 6 months |
| Total daily insulin dose. | 6 months |
| Lipid spectrum | 6 months |
| Health related quality of life | 6 months |
| Diabetes related quality of life | 6 months |
| 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). | 6 months |
| Diabetes related self care | 6 months |
| Treatment satisfaction | 6 months |
| body mass index | 6 months |
| Blood pressure | 6 months |
| Microvascular complications of diabetes | 6 months |
| Macrovascular complications of diabetes | 6 months |
| Diabetes related distress | 6 months |
Countries
Netherlands
Outcome results
None listed