Clinical trial NCT00598663: SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
Official title: Randomized, Cross Over, Controlled, Multi-centric Study to Assess Whether Type 1 Diabetic Patients in Sub-optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Paradigm Insulin Pump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2008-01-22
Enrollment: 153
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
* Sub-optimal glycemic control (7.5%\<HbA1c\<9.5%).
* Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
* Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
* Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.

Exclusion Criteria:

* Existing pregnancy or intention to conceive (as assessed by investigator).
* Hearing or vision impairment so that glucose display and alarms cannot be recognized.
* Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
* History of hypoglycemic unawareness as assessed by the investigator.
* Alcohol or drug abuse, other than nicotine.
* Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
* Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index \>35 and children Body Mass Index \> 2 standard deviations. for age) as assessed by the investigator.
* Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
* For pediatric subjects: does not have a reliable support person.
* Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
* Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.

Primary outcomes:
measure: HbA1c at 6 Month
timeFrame: 6 months
Secondary outcomes:
measure: Glycemic Variability
timeFrame: 6 months
measure: Number of Severe Hypoglycemia Events
timeFrame: 6 months
measure: Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
timeFrame: 6 months
measure: Postprandial Glycaemia
timeFrame: 6 months
measure: Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
timeFrame: 6 months
measure: Diabetic Ketoacidosis Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hospital Hietzing
city: Copenhagen
country: Denmark
facility: Steno Diabetes Center
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Rome
country: Italy
facility: Clinica Pediatrica, Policlinico Umberto I
city: Luxembourg
country: Luxembourg
facility: Center Hospitalier de Luxembourg
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Ljubljana
country: Slovenia
facility: University Children's Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic i Universitari
Study officials:
affiliation: University Children's Hospital
name: Dr. T Battelino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battelino T, Conget I, Olsen B, Schutz-Fuhrmann I, Hommel E, Hoogma R, Schierloh U, Sulli N, Bolinder J; SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia. 2012 Dec;55(12):3155-62. doi: 10.1007/s00125-012-2708-9. Epub 2012 Sep 11.