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SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c (SWITCH)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 diabetes

Eligibility Criteria

6 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Hietzing
  • Steno Diabetes Center
  • Glostrup Hospital
  • Clinica Pediatrica, Policlinico Umberto I
  • Center Hospitalier de Luxembourg
  • Groene Hart Ziekenhuis
  • University Children's Hospital
  • Hospital Clinic i Universitari

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Off/On

On/Off

Arm Description

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]

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]

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glycemic Variability
24 h SD of glucose values (mg/dl)
Number of Severe Hypoglycemia Events
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
Postprandial Glycaemia
Breakfast Postprandial glycaemia
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
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.

Full Information

First Posted
December 5, 2007
Last Updated
August 13, 2019
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT00598663
Brief Title
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
Acronym
SWITCH
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Type 1 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Off/On
Arm Type
Experimental
Arm Description
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]
Arm Title
On/Off
Arm Type
Experimental
Arm Description
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]
Intervention Type
Device
Intervention Name(s)
insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
Other Intervention Name(s)
Paradigm Real-Time Insulin Pump System, Medtronic MMT-522 or MMT-722 + MMT7707WW
Intervention Description
6 months of pump plus continuous glucose sensing in conjunction to SMBG
Intervention Type
Device
Intervention Name(s)
insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
Other Intervention Name(s)
Paradigm Real-Time insulin pump, Guardian Real-Time clinical, MMT-522 or MMT-722 + MMT7707WW + CSS7100
Intervention Description
insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.
Primary Outcome Measure Information:
Title
HbA1c at 6 Month
Description
The end of period difference in HbA1c after 6 months of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Glycemic Variability
Description
24 h SD of glucose values (mg/dl)
Time Frame
6 months
Title
Number of Severe Hypoglycemia Events
Time Frame
6 months
Title
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
Time Frame
6 months
Title
Postprandial Glycaemia
Description
Breakfast Postprandial glycaemia
Time Frame
6 months
Title
Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
Description
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
Title
Diabetic Ketoacidosis Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. T Battelino
Organizational Affiliation
University Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Hietzing
City
Vienna
Country
Austria
Facility Name
Steno Diabetes Center
City
Copenhagen
Country
Denmark
Facility Name
Glostrup Hospital
City
Glostrup
Country
Denmark
Facility Name
Clinica Pediatrica, Policlinico Umberto I
City
Rome
Country
Italy
Facility Name
Center Hospitalier de Luxembourg
City
Luxembourg
Country
Luxembourg
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
University Children's Hospital
City
Ljubljana
Country
Slovenia
Facility Name
Hospital Clinic i Universitari
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22965294
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.
Results Reference
derived

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SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

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