Trial Outcomes & Findings for Threshold Suspend in Pediatrics at Home (NCT NCT02120794)
NCT ID: NCT02120794
Last Updated: 2018-09-11
Results Overview
The overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
194 participants
Primary outcome timeframe
Baseline and 1 year after screening
Results posted on
2018-09-11
Participant Flow
Participant milestones
| Measure |
530G Insulin Pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Overall Study
STARTED
|
194
|
|
Overall Study
COMPLETED
|
136
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
| Measure |
530G Insulin Pump
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
43
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Due to insurance coverage
|
1
|
Baseline Characteristics
Threshold Suspend in Pediatrics at Home
Baseline characteristics by cohort
| Measure |
530G Insulin Pump
n=194 Participants
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 2.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
194 particpants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 year after screeningThe overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.
Outcome measures
| Measure |
530G Insulin Pump
n=132 Participants
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Overall Mean Change in A1C
|
0.26 percentage
Interval 0.125 to 0.395
|
SECONDARY outcome
Timeframe: Baseline and 1 year after screeningMean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7%
Outcome measures
| Measure |
530G Insulin Pump
n=3 Participants
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
|
0.37 percentage
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline and 1 year after screeningMean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9%
Outcome measures
| Measure |
530G Insulin Pump
n=97 Participants
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
|
0.34 percentage
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Baseline and 1 year after screeningMean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c \> 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c \> 9%
Outcome measures
| Measure |
530G Insulin Pump
n=32 Participants
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups
|
-0.02 percentage
Standard Deviation 1.27
|
Adverse Events
530G Insulin Pump
Serious events: 4 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
530G Insulin Pump
n=194 participants at risk
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Metabolism and nutrition disorders
Severe Hyperglycemia
|
0.52%
1/194 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Dabetic Ketoacidosis
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.52%
1/194 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Second Degree Burns to lower distal extremeties
|
0.52%
1/194 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
530G Insulin Pump
n=194 participants at risk
Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
530G Insulin pump: Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Acute sinusitis
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Immune system disorders
Allergy to arthropod sting
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Immune system disorders
Anaphylactic reaction
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
1.5%
3/194 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Body dysmorphic disorder
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchitis
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
General disorders
Chest pain
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Concussion
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Infections and infestations
Conjunctivitis
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Nervous system disorders
Convulsion
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
6/194 • Number of events 9 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.52%
1/194 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.6%
5/194 • Number of events 5 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Ear infection
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Ear and labyrinth disorders
Ear pain
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Encephalitis viral
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Nervous system disorders
Epilepsy
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Fear of injection
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
3.1%
6/194 • Number of events 6 • 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
2.1%
4/194 • Number of events 4 • 1 year
|
|
Infections and infestations
Gastrointestinal viral infection
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Investigations
Giardia test positive
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.52%
1/194 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.5%
3/194 • Number of events 3 • 1 year
|
|
Nervous system disorders
Headache
|
3.1%
6/194 • Number of events 11 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.4%
28/194 • Number of events 44 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.1%
4/194 • Number of events 4 • 1 year
|
|
Infections and infestations
Influenza
|
2.6%
5/194 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Ketonuria
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
General disorders
Medical device discomfort
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
General disorders
Medical device pain
|
4.1%
8/194 • Number of events 9 • 1 year
|
|
General disorders
Medical device site reaction
|
8.8%
17/194 • Number of events 23 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Nervous system disorders
Migraine
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Infections and infestations
Mononucleosis syndrome
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
4/194 • Number of events 4 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/194 • Number of events 3 • 1 year
|
|
Infections and infestations
Onychomycosis
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.0%
2/194 • Number of events 3 • 1 year
|
|
Infections and infestations
Otitis media
|
1.5%
3/194 • Number of events 4 • 1 year
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Pharyngitis
|
1.0%
2/194 • Number of events 3 • 1 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
4.1%
8/194 • Number of events 11 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
General disorders
Pyrexia
|
1.0%
2/194 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
10/194 • Number of events 10 • 1 year
|
|
Infections and infestations
Respiratory tract infection viral
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Immune system disorders
Seasonal allergy
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Sinusitis
|
2.6%
5/194 • Number of events 6 • 1 year
|
|
Infections and infestations
Skin infection
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
10.3%
20/194 • Number of events 28 • 1 year
|
|
Nervous system disorders
Syncope
|
1.5%
3/194 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Tinea cruris
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Tonsillitis
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillolith
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Tooth impacted
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
0.52%
1/194 • Number of events 2 • 1 year
|
|
Investigations
Tuberculin test positive
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
9.3%
18/194 • Number of events 22 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
General disorders
Vessel puncture site pain
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Infections and infestations
Viral infection
|
2.1%
4/194 • Number of events 4 • 1 year
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.52%
1/194 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
4/194 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.0%
2/194 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.52%
1/194 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60