SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

NCT00598663 | Completed Results

• 2 other identifiers: EUR03ISRCTN09806152
• Study Type: interventional
• Target: 153
• Locations: 7 countries
• Sites: 8

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c at 6 Month

  The end of period difference in HbA1c after 6 months of treatment

  6 months

Secondary Outcomes (6)

• Glycemic Variability

  6 months

• Number of Severe Hypoglycemia Events

  6 months

• Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)

  6 months

• Postprandial Glycaemia

  6 months

• Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)

  6 months

Study Arms (2)

Off/On

EXPERIMENTAL

6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\] 4 month wash out period 6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]

Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)

On/Off

EXPERIMENTAL

6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\] 4 month wash out period 6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]

Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)

Interventions

insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) DEVICE

6 months of pump plus continuous glucose sensing in conjunction to SMBG

Also known as: Paradigm Real-Time Insulin Pump System, Medtronic MMT-522 or MMT-722 + MMT7707WW

Off/On

insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) DEVICE

insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.

Also known as: Paradigm Real-Time insulin pump, Guardian Real-Time clinical, MMT-522 or MMT-722 + MMT7707WW + CSS7100

On/Off

Eligibility Criteria

• Age: 6 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (8)

Hospital Hietzing

Vienna, Austria

Location

Steno Diabetes Center

Copenhagen, Denmark

Location

Glostrup Hospital

Glostrup Municipality, Denmark

Location

Clinica Pediatrica, Policlinico Umberto I

Rome, Italy

Location

Center Hospitalier de Luxembourg

Luxembourg, Luxembourg

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

University Children's Hospital

Ljubljana, Slovenia

Location

Hospital Clinic i Universitari

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 22965294 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Tadej Battelino
• Organization: University Children's Hospital Vrazov trg 1 SI-1525 Ljubljana, Slovenia

tadej.battelino@mf.uni-lj.si

+386 1 522 50 50

Study Officials

• Dr. T Battelino

  University Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: January 22, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-08

Locations

AU (1); SL (1); DK (2); LU (1); IT (1); NL (1); ES (1)