CompletedNCT00598663SWITCHUpdated Sep 16, 2019Results posted

SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

An interventional study of 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 Diabetes Mellitus, Type 1, sponsored by Medtronic Diabetes. Completed at 8 sites in 7 countries. Open to participants aged 6 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-16.

Sponsored by Medtronic Diabetes · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 153
Allocation: Randomized
Ages: 6 Years to 70 Years
Sex: All

Study 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 studied

Diabetes Mellitus, Type 1

Browse trials for

Diabetes Mellitus, Type 1 3,522

Keywords

Type 1 diabetes

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 153 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Medtronic Diabetes is the lead sponsor of 61 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 21 (95%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 153 participants (actual)

Study arms

Experimental
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) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
Experimental
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 \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)

Interventions

Deviceinsulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
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
Deviceinsulin 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.
Also known as: Paradigm Real-Time insulin pump, Guardian Real-Time clinical, MMT-522 or MMT-722 + MMT7707WW + CSS7100

What researchers measure

Primary outcomes

HbA1c at 6 Month
The end of period difference in HbA1c after 6 months of treatment
Time frame: 6 months

Secondary outcomes

Glycemic Variability
24 h SD of glucose values (mg/dl)
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
Breakfast Postprandial glycaemia
Time frame: 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
Time frame: 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.
Time frame: 6 months

Results

Posted Sep 16, 2019

Participant flow

First Intervention (6 Months)

Participant flow — First Intervention (6 Months)
Milestone	Off/On	On/Off
Started	76	77
Completed	73	71
Not completed	3	6

Washout (4 Months)

Participant flow — Washout (4 Months)
Milestone	Off/On	On/Off
Started	73	71
Completed	73	70
Not completed	0	1

Second Intervention (6 Months)

Participant flow — Second Intervention (6 Months)
Milestone	Off/On	On/Off
Started	73	70
Completed	69	69
Not completed	4	1

Outcome measures

PrimaryHbA1c at 6 Month

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

Time frame:: 6 months
Reported as:: Mean · percentage of glycosylated hemoglobin

HbA1c at 6 Month
percentage of glycosylated hemoglobin	Sensor Off Arm	Sensor ON Arm
HbA1c at 6 Month	8.47 ± 0.96	8.04 ± 0.87

Statistical analysis

Sensor Off Arm vs Sensor ON Arm · ANCOVA · p = <0.0001 · Mean difference (final values): 0.43ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.

SecondaryGlycemic Variability

24 h SD of glucose values (mg/dl)

Time frame:: 6 months
Reported as:: Mean · mg/dl

Glycemic Variability
mg/dl	Sensor Off Arm	Sensor On Arm
Glycemic Variability	77.16 ± 21.43	71.58 ± 20.20

SecondaryNumber of Severe Hypoglycemia Events

Time frame:: 6 months
Reported as:: Number · participants

Number of Severe Hypoglycemia Events
participants	Sensor Off	Sensor On
Number of Severe Hypoglycemia Events	2	4

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

Time frame:: 6 months
Reported as:: Mean · minutes

Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
minutes	Sensor Off Arm	Sensor ON Arm
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)	669 ± 208	774 ± 232

SecondaryPostprandial Glycaemia

Breakfast Postprandial glycaemia

Time frame:: 6 months
Reported as:: Mean · mg/dl

Postprandial Glycaemia
mg/dl	Sensor Off Arm	Sensor ON Arm
Postprandial Glycaemia	157.7 ± 24.5	160.4 ± 31.3

SecondaryPediatric 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

Time frame:: 6 months
Reported as:: Mean · units on a scale

Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
units on a scale	Sensor Off	Sensor On
Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)	85.11 ± 9.49	84.75 ± 10.41

SecondaryDiabetic 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.

Time frame:: 6 months
Reported as:: Count of participants · Participants

Diabetic Ketoacidosis Events
Participants	Sensor Off	Sensor On
Diabetic Ketoacidosis Events	3	2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sensor Off	0/153 (0%)	5/153 (3.3%)	64/153 (41.8%)
Sensor On	0/153 (0%)	6/153 (3.9%)	52/153 (34%)

Most frequent serious events

Most frequent serious events
Event	Sensor Off	Sensor On
Severe Hypoglycemic EventMetabolism and nutrition disorders	2/153	4/153
Diabetic KetoacidosisMetabolism and nutrition disorders	3/153	2/153

Most frequent other events

Showing 10 of 93

Most frequent other events
Event	Sensor Off	Sensor On
GastroenteritisInfections and infestations	11/153	3/153
ColdInfections and infestations	10/153	7/153
FluInfections and infestations	6/153	2/153
GastroenterocolitisInfections and infestations	5/153	0/153
Upper respiratory tract infeInfections and infestations	5/153	3/153
Viral infectionInfections and infestations	2/153	4/153
Common coldInfections and infestations	0/153	3/153
TonsillitisInfections and infestations	0/153	3/153
Adverse event NOSGeneral disorders	0/153	2/153
Blurred visionEye disorders	2/153	0/153

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Off/On	On/Off	Total
Mean	28 ± 17	28 ± 16	28 ± 17

Sex: Female, Male
Sex: Female, Male(Participants)	Off/On	On/Off	Total
Female	39	35	74
Male	37	42	79

Study locations

8 sites

Hospital Hietzing
Vienna, Austria
Steno Diabetes Center
Copenhagen, Denmark
Glostrup Hospital
Glostrup, 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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00598663
Lead sponsor: Medtronic Diabetes
Responsible party: Sponsor
First posted: Jan 22, 2008
Start date: Jan 2008
Primary completion: Jul 2010
Completion: Jul 2010
Results posted: Sep 16, 2019
Last update: Sep 16, 2019

Study contacts

Dr. T Battelino

principal investigator · University Children's Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 1→

Other studies from this sponsor

Medtronic Diabetes

Start the discussion