Trial Outcomes & Findings for SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c (NCT NCT00598663)
NCT ID: NCT00598663
Last Updated: 2019-09-16
Results Overview
The end of period difference in HbA1c after 6 months of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
6 months
Results posted on
2019-09-16
Participant Flow
Cross-over design 1 month run-in before randomization 4 month wash out period
Participant milestones
| Measure |
Off/On
Sequence Off/On
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) and Self Monitoring Blood Glucose
Wash out period: 4 months
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) + personal continuous glucose monitoring (personal CGM)
|
On/Off
Sequence On/Off
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) + personal continuous glucose monitoring (personal CGM)
Wash out period: 4 months
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII, (Paradigm Real-Time Insulin Pump System) and Self Monitoring Blood Glucose
|
|---|---|---|
|
First Intervention (6 Months)
STARTED
|
76
|
77
|
|
First Intervention (6 Months)
COMPLETED
|
73
|
71
|
|
First Intervention (6 Months)
NOT COMPLETED
|
3
|
6
|
|
Washout (4 Months)
STARTED
|
73
|
71
|
|
Washout (4 Months)
COMPLETED
|
73
|
70
|
|
Washout (4 Months)
NOT COMPLETED
|
0
|
1
|
|
Second Intervention (6 Months)
STARTED
|
73
|
70
|
|
Second Intervention (6 Months)
COMPLETED
|
69
|
69
|
|
Second Intervention (6 Months)
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
Baseline characteristics by cohort
| Measure |
Off/On
n=76 Participants
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
n=77 Participants
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 \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 17 • n=5 Participants
|
28 years
STANDARD_DEVIATION 16 • n=7 Participants
|
28 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe end of period difference in HbA1c after 6 months of treatment
Outcome measures
| Measure |
Sensor Off Arm
n=153 Participants
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Arms/Groups are reported on a "per intervention" basis
|
Sensor ON Arm
n=153 Participants
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Arms/Groups are reported on a "per intervention" basis
|
|---|---|---|
|
HbA1c at 6 Month
|
8.47 percentage of glycosylated hemoglobin
Standard Deviation 0.96
|
8.04 percentage of glycosylated hemoglobin
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 6 months24 h SD of glucose values (mg/dl)
Outcome measures
| Measure |
Sensor Off Arm
n=153 Participants
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Arms/Groups are reported on a "per intervention" basis
|
Sensor ON Arm
n=153 Participants
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Arms/Groups are reported on a "per intervention" basis
|
|---|---|---|
|
Glycemic Variability
|
77.16 mg/dl
Standard Deviation 21.43
|
71.58 mg/dl
Standard Deviation 20.20
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Sensor Off Arm
n=153 Participants
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Arms/Groups are reported on a "per intervention" basis
|
Sensor ON Arm
n=153 Participants
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Arms/Groups are reported on a "per intervention" basis
|
|---|---|---|
|
Number of Severe Hypoglycemia Events
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Sensor Off Arm
n=153 Participants
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Arms/Groups are reported on a "per intervention" basis
|
Sensor ON Arm
n=153 Participants
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Arms/Groups are reported on a "per intervention" basis
|
|---|---|---|
|
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
|
669 minutes
Standard Deviation 208
|
774 minutes
Standard Deviation 232
|
SECONDARY outcome
Timeframe: 6 monthsBreakfast Postprandial glycaemia
Outcome measures
| Measure |
Sensor Off Arm
n=153 Participants
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Arms/Groups are reported on a "per intervention" basis
|
Sensor ON Arm
n=153 Participants
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Arms/Groups are reported on a "per intervention" basis
|
|---|---|---|
|
Postprandial Glycaemia
|
157.7 mg/dl
Standard Deviation 24.5
|
160.4 mg/dl
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: In total 72 children took part in the clinical trial: 8 young children (6-7 years), 26 children (8-12 years) and 38 teenagers (13-17 years). Arms/Groups are reported on a "per intervention" basis
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
Outcome measures
| Measure |
Sensor Off Arm
n=72 Participants
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Arms/Groups are reported on a "per intervention" basis
|
Sensor ON Arm
n=72 Participants
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Arms/Groups are reported on a "per intervention" basis
|
|---|---|---|
|
Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
|
85.11 units on a scale
Standard Deviation 9.49
|
84.75 units on a scale
Standard Deviation 10.41
|
SECONDARY outcome
Timeframe: 6 monthsA 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.
Outcome measures
| Measure |
Sensor Off Arm
n=153 Participants
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
Arms/Groups are reported on a "per intervention" basis
|
Sensor ON Arm
n=153 Participants
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
Arms/Groups are reported on a "per intervention" basis
|
|---|---|---|
|
Diabetic Ketoacidosis Events
|
3 Participants
|
2 Participants
|
Adverse Events
Sensor Off
Serious events: 5 serious events
Other events: 64 other events
Deaths: 0 deaths
Sensor On
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sensor Off
n=153 participants at risk
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
|
Sensor On
n=153 participants at risk
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
|
|---|---|---|
|
Metabolism and nutrition disorders
Severe Hypoglycemic Event
|
1.3%
2/153 • Number of events 2
|
2.6%
4/153 • Number of events 4
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
2.0%
3/153 • Number of events 4
|
1.3%
2/153 • Number of events 2
|
Other adverse events
| Measure |
Sensor Off
n=153 participants at risk
6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose \[Device: Paradigm® Real-Time pump with Sensor Off feature\]
|
Sensor On
n=153 participants at risk
6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) \[Device: Paradigm® Real-Time pump with Sensor On feature continuously\]
|
|---|---|---|
|
Infections and infestations
Abscess
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Abscess on buttock
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Renal and urinary disorders
Acetonuria
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Acute bronchitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Acute tonsillitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Adhesive tape allergy
|
0.65%
1/153 • Number of events 2
|
0.00%
0/153
|
|
General disorders
Adverse event NOS
|
0.00%
0/153
|
1.3%
2/153 • Number of events 2
|
|
Immune system disorders
Allergy
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Injury, poisoning and procedural complications
Arm fracture
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Atopic dermatitis
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Renal and urinary disorders
Bladder disorder
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Eye disorders
Blurred vision
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Surgical and medical procedures
Breast reconstruction
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
General disorders
Catheter site dermatitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Respiratory, thoracic and mediastinal disorders
Chronic cough
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Cold
|
6.5%
10/153 • Number of events 11
|
4.6%
7/153 • Number of events 8
|
|
Infections and infestations
Common cold
|
0.00%
0/153
|
2.0%
3/153 • Number of events 3
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/153
|
1.3%
2/153 • Number of events 2
|
|
Nervous system disorders
Epileptic fit
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Eye disorders
Eye disorder
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
General disorders
Fever
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Flu
|
3.9%
6/153 • Number of events 6
|
1.3%
2/153 • Number of events 4
|
|
Injury, poisoning and procedural complications
Foot sprain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Gastroenteritis
|
7.2%
11/153 • Number of events 11
|
2.0%
3/153 • Number of events 3
|
|
Infections and infestations
Gastroenterocolitis
|
3.3%
5/153 • Number of events 5
|
0.00%
0/153
|
|
Nervous system disorders
Headache
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
General disorders
Hernia
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Impetigo
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Infected finger
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Infection
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Influenza
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Injection site infection
|
0.00%
0/153
|
1.3%
2/153 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Jaw inflammation
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/153
|
1.3%
2/153 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration of hand
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
0.00%
0/153
|
0.65%
1/153 • Number of events 2
|
|
General disorders
Medical device site erythema
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
General disorders
Medical device site hematoma
|
0.65%
1/153 • Number of events 2
|
0.00%
0/153
|
|
General disorders
Medical device site hyperker
|
0.65%
1/153 • Number of events 1
|
1.3%
2/153 • Number of events 2
|
|
Infections and infestations
Medical device site infectio
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
General disorders
Medical device site irritati
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
General disorders
Medical device site pain
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
General disorders
Medical device site reaction
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Psychiatric disorders
Mental distress
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Nervous system disorders
Migraine
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Endocrine disorders
Myxedema
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Psychiatric disorders
Obsessive-compulsive disorde
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Odontitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Otitis
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Nervous system disorders
Paresthesia lower limb
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Pharyngotonsillitis
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Surgical and medical procedures
Plastic surgery
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Pneumonia
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Postoperative infection
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Post-traumatic wound infecti
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Psychiatric disorders
Psychological disorder NOS
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin eruption
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Infections and infestations
Streptoderma
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
Social circumstances
Stress at work
|
0.00%
0/153
|
0.65%
1/153 • Number of events 1
|
|
General disorders
Thorax pain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Vascular disorders
Thrombophlebitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/153
|
2.0%
3/153 • Number of events 3
|
|
Surgical and medical procedures
Tooth extraction
|
1.3%
2/153 • Number of events 2
|
0.00%
0/153
|
|
Infections and infestations
Tooth infection
|
0.65%
1/153 • Number of events 1
|
0.65%
1/153 • Number of events 1
|
|
Gastrointestinal disorders
Tooth pain
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Upper respiratory tract infe
|
3.3%
5/153 • Number of events 6
|
2.0%
3/153 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Ear and labyrinth disorders
Vertigo
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
|
Infections and infestations
Viral infection
|
1.3%
2/153 • Number of events 2
|
2.6%
4/153 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/153 • Number of events 1
|
0.00%
0/153
|
Additional Information
Tadej Battelino
University Children's Hospital Vrazov trg 1 SI-1525 Ljubljana, Slovenia
Phone: +386 1 522 50 50
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place