Diabetes Mellitus, Type 1SWITCHNCT00598663
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
A study testing insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) and insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 8 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) and insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Jan 2008to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Show all 11Show fewer
- 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.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Denmark2 sites
Steno Diabetes Center
Copenhagen
Glostrup Hospital
Glostrup Municipality
About this study
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
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
- Being tested
- insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System), insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
- Keywords
- Type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)Device
Also called Paradigm Real-Time Insulin Pump System, Medtronic MMT-522 or MMT-722 + MMT7707WW
6 months of pump plus continuous glucose sensing in conjunction to SMBG
insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)Device
Also called Paradigm Real-Time insulin pump, Guardian Real-Time clinical, MMT-522 or MMT-722 + MMT7707WW + CSS7100
insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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] Receives: Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c at 6 Month
The end of period difference in HbA1c after 6 months of treatment
Measured: 6 months
Secondary outcomes (6)
Glycemic Variability
24 h SD of glucose values (mg/dl)
Measured: 6 months
Number of Severe Hypoglycemia Events
Measured: 6 months
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
Measured: 6 months
Postprandial Glycaemia
Breakfast Postprandial glycaemia
Measured: 6 months
Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998).
Scores are transformed on a scale from 0 to 100. higher values represent a better outcome
Measured: 6 months
Diabetic Ketoacidosis Events
A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose >250 mg/dL) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. T Battelino, Principal investigator, University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598663
- Sponsor's protocol ID
- EUR03
- Other IDs
- ISRCTN09806152
- Acronym
- SWITCH
- Status last verified
- Aug 2019
- First submitted
- 5 Dec 2007
- Last updated
- 16 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22965294
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00598663
- Acronym / sponsor ID
- SWITCH / EUR03
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Jan 2008 (estimated)
- Results
- Posted 16 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off/On | Experimental | Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)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] |
| On/Off | Experimental | Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)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] |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)Also: Paradigm Real-Time Insulin Pump System, Medtronic MMT-522 or MMT-722 + MMT7707WW6 months of pump plus continuous glucose sensing in conjunction to SMBG | Device | Off/On |
| insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)Also: Paradigm Real-Time insulin pump, Guardian Real-Time clinical, MMT-522 or MMT-722 + MMT7707WW + CSS7100insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted. | Device | On/Off |
Primary outcome
HbA1c at 6 Month
Time frame: 6 months
The end of period difference in HbA1c after 6 months of treatment
6 secondary outcomes
Glycemic Variability
Time frame: 6 months
Number of Severe Hypoglycemia Events
Time frame: 6 months
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
Time frame: 6 months
Postprandial Glycaemia
Time frame: 6 months
Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
Time frame: 6 months
Diabetic Ketoacidosis Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22965294Battelino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. T Battelino principal investigator
University Children's Hospital
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) and insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) in people with Diabetes Mellitus, Type 1, run by Medtronic MiniMed, Inc. at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark, Austria, Italy, Luxembourg, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c at 6 Month (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00598663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019; AzTrials last refreshed its copy on 31 Oct 2026.