SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

NCT ID: NCT00598663

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Off/On

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]

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

On/Off

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]

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Other Intervention Names

Paradigm Real-Time Insulin Pump System; Medtronic MMT-522 or MMT-722 + MMT7707WW; Paradigm Real-Time insulin pump; Guardian Real-Time clinical; MMT-522 or MMT-722 + MMT7707WW + CSS7100

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. T Battelino

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital

Locations

Hospital Hietzing

Vienna, , Austria

Steno Diabetes Center

Copenhagen, , Denmark

Glostrup Hospital

Glostrup Municipality, , Denmark

Clinica Pediatrica, Policlinico Umberto I

Rome, , Italy

Center Hospitalier de Luxembourg

Luxembourg, , Luxembourg

Groene Hart Ziekenhuis

Gouda, , Netherlands

University Children's Hospital

Ljubljana, , Slovenia

Hospital Clinic i Universitari

Barcelona, , Spain

Countries

Austria; Denmark; Italy; Luxembourg; Netherlands; Slovenia; Spain

References

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.

Reference Type: DERIVED

PMID: 22965294 (View on PubMed)

Other Identifiers

ISRCTN09806152

Identifier Type: -

Identifier Source: secondary_id

EUR03

Identifier Type: -

Identifier Source: org_study_id