Trial Outcomes & Findings for Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes (NCT NCT02660827)
NCT ID: NCT02660827
Last Updated: 2022-01-26
Results Overview
Descriptive analysis of change in A1C from baseline to end of 3-month study period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
Baseline and end of 3-month study period
Results posted on
2022-01-26
Participant Flow
151 subjects aged 2-13 years entered study period, 1 subject withdrawn during study period, 5 subjects didn't participate continued access period after finishing study period; 145 subjects aged 2-13 years entered continued access period, 25 subjects withdrawn and 120 subjects completed continued access period.
2-13 years subjects wearing MMT-670G insulin pump
Participant milestones
| Measure |
Subjects Wearing MMT-670G Insulin Pump
Subjects wearing MMT- 670G insulin pump during Study and Continued Access period
|
|---|---|
|
From Study to End of Continued Access
STARTED
|
151
|
|
From Study to End of Continued Access
COMPLETED
|
120
|
|
From Study to End of Continued Access
NOT COMPLETED
|
31
|
|
Period 1: Study Period
STARTED
|
151
|
|
Period 1: Study Period
COMPLETED
|
150
|
|
Period 1: Study Period
NOT COMPLETED
|
1
|
|
Period 2: Continued Access Period
STARTED
|
145
|
|
Period 2: Continued Access Period
COMPLETED
|
120
|
|
Period 2: Continued Access Period
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Subjects Wearing MMT-670G Insulin Pump
Subjects wearing MMT- 670G insulin pump during Study and Continued Access period
|
|---|---|
|
From Study to End of Continued Access
Withdrawal by Subject
|
21
|
|
From Study to End of Continued Access
Withdrawal by Sponsor
|
2
|
|
From Study to End of Continued Access
Adverse Event
|
3
|
|
From Study to End of Continued Access
didn't participate continued access period
|
5
|
|
Period 1: Study Period
Withdrawal by Subject
|
1
|
|
Period 2: Continued Access Period
Withdrawal by Subject
|
20
|
|
Period 2: Continued Access Period
Withdrawal by Sponsor
|
2
|
|
Period 2: Continued Access Period
Adverse Event
|
3
|
Baseline Characteristics
One Subject's height and weight were not measured at enrollment.
Baseline characteristics by cohort
| Measure |
Age 2-13 Yrs
n=151 Participants
Age 2-13 Yrs Subjects wearing MMT- 670G insulin pump
|
|---|---|
|
Age, Continuous
|
8.9 years
STANDARD_DEVIATION 3.3 • n=151 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=151 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=151 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=151 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=151 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=151 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=151 Participants
|
|
Region of Enrollment
United States
|
140 participants
n=151 Participants
|
|
Region of Enrollment
Israel
|
11 participants
n=151 Participants
|
|
BMI (kg/m2)
|
18.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=150 Participants • One Subject's height and weight were not measured at enrollment.
|
PRIMARY outcome
Timeframe: Baseline and end of 3-month study periodPopulation: 2-13 years old subjects wearing MMT-670G insulin pump; two subjects end of study A1C not collected.
Descriptive analysis of change in A1C from baseline to end of 3-month study period
Outcome measures
| Measure |
Age 2-13 Years Old Wearing MMT-670G Insulin Pump
n=149 Participants
2-13 years old subjects wearing MMT-670G insulin pump.
|
|---|---|
|
Age 2-13 Years Old Subjects Change in A1C
|
-0.37 percentage of hemoglobin
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 2-13 years old subjects wearing MMT-670G insulin pump.
mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period
Outcome measures
| Measure |
Age 2-13 Years Old Wearing MMT-670G Insulin Pump
n=151 Participants
2-13 years old subjects wearing MMT-670G insulin pump.
|
|---|---|
|
Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL)
|
8.58 Percentage of time
Standard Deviation 8.84
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 2-13 years old subjects wearing MMT-670G insulin pump.
mean change in % of time in hyperglycemia (\> 180 mg/dL) from baseline to 3 months study period
Outcome measures
| Measure |
Age 2-13 Years Old Wearing MMT-670G Insulin Pump
n=151 Participants
2-13 years old subjects wearing MMT-670G insulin pump.
|
|---|---|
|
Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)
|
-7.39 Percent of time
Standard Deviation 9.96
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 2-13 years old subjects wearing MMT-670G insulin pump.
mean change in % of time in hypoglycemia (\< 70 mg/dL) from baseline to 3 months study period
Outcome measures
| Measure |
Age 2-13 Years Old Wearing MMT-670G Insulin Pump
n=151 Participants
2-13 years old subjects wearing MMT-670G insulin pump.
|
|---|---|
|
Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)
|
-1.19 percent of time
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 2-13 years old subjects wearing MMT-670G insulin pump.
Number of severe hypoglycemic events occurred during 3-month study period.
Outcome measures
| Measure |
Age 2-13 Years Old Wearing MMT-670G Insulin Pump
n=151 Participants
2-13 years old subjects wearing MMT-670G insulin pump.
|
|---|---|
|
Age 2-13 Years Old - Number of Severe Hypoglycemic Event
|
0 events
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 2-13 years old subjects wearing MMT-670G insulin pump.
Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period.
Outcome measures
| Measure |
Age 2-13 Years Old Wearing MMT-670G Insulin Pump
n=151 Participants
2-13 years old subjects wearing MMT-670G insulin pump.
|
|---|---|
|
Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event
|
0 events
|
SECONDARY outcome
Timeframe: Up to 12 hours after the start of PLGM periodPopulation: 7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.
Event rate without Hypoglycemia at YSI-FST \<=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST \<= 65mg/dL during in-clinic procedures.
Outcome measures
| Measure |
Age 2-13 Years Old Wearing MMT-670G Insulin Pump
n=105 Participants
2-13 years old subjects wearing MMT-670G insulin pump.
|
|---|---|
|
Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL
|
84.8 percentage of total experiments
|
Adverse Events
Age 2-13 Yrs Study Period
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
Age 2-13 Yrs Continued Access Period
Serious events: 4 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Age 2-13 Yrs Study Period
n=151 participants at risk
2-13 years old subjects wearing MMT-670G insulin pump during Study period.
|
Age 2-13 Yrs Continued Access Period
n=145 participants at risk
2-13 years old subjects wearing MMT-670G insulin pump during Continued Access period.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
Other adverse events
| Measure |
Age 2-13 Yrs Study Period
n=151 participants at risk
2-13 years old subjects wearing MMT-670G insulin pump during Study period.
|
Age 2-13 Yrs Continued Access Period
n=145 participants at risk
2-13 years old subjects wearing MMT-670G insulin pump during Continued Access period.
|
|---|---|---|
|
Infections and infestations
Periumbilical abscess
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
9.7%
14/145 • Number of events 15 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Pyrexia
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.8%
7/145 • Number of events 7 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
3.4%
5/145 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Rhinovirus infection
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Sinusitis
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.1%
6/145 • Number of events 7 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Skin infection
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 3 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.3%
5/151 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Nervous system disorders
Syncope
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Tonsillitis
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Torus fracture
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
8/151 • Number of events 8 • 3 months for Study period, up to 3 years for Continued Access period.
|
13.8%
20/145 • Number of events 28 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Viral infection
|
3.3%
5/151 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
5.5%
8/145 • Number of events 9 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Viral pharyngitis
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.1%
6/145 • Number of events 6 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
3.4%
5/145 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.1%
3/145 • Number of events 3 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Abscess limb
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Metabolism and nutrition disorders
Acetonaemia
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Investigations
Blood ketone body increased
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Bronchitis
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Cellulitis
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.1%
3/145 • Number of events 3 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.8%
4/145 • Number of events 4 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.1%
3/145 • Number of events 4 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.1%
6/145 • Number of events 6 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Constipation
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.66%
1/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.1%
6/145 • Number of events 7 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Dacryocanaliculitis
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Ear infection
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.1%
6/145 • Number of events 8 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.3%
2/151 • Number of events 3 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Immune system disorders
Food allergy
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Gastroenteritis
|
4.6%
7/151 • Number of events 8 • 3 months for Study period, up to 3 years for Continued Access period.
|
10.3%
15/145 • Number of events 17 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.1%
6/145 • Number of events 10 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Gastrointestinal infection
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Greenstick fracture
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.1%
3/145 • Number of events 3 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.1%
3/145 • Number of events 3 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Nervous system disorders
Headache
|
2.6%
4/151 • Number of events 4 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Investigations
Helicobacter test positive
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Herpangina
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Herpes zoster
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
37.1%
56/151 • Number of events 146 • 3 months for Study period, up to 3 years for Continued Access period.
|
48.3%
70/145 • Number of events 372 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
3.4%
5/145 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Impetigo
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Influenza
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
4.8%
7/145 • Number of events 8 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Influenza like illness
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
1.4%
2/145 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Infusion site infection
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
3.4%
5/145 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Injury associated with device
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.8%
4/145 • Number of events 4 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Skin and subcutaneous tissue disorders
Lipoatrophy
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Medical device site abscess
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Medical device site infection
|
1.3%
2/151 • Number of events 2 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Medical device site rash
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Medical device site reaction
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Nervous system disorders
Migraine
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Molluscum contagiosum
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
3/151 • Number of events 3 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
5/151 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
5.5%
8/145 • Number of events 12 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
2.8%
4/145 • Number of events 4 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Otitis externa
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.69%
1/145 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Otitis media
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
3.4%
5/145 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/151 • 3 months for Study period, up to 3 years for Continued Access period.
|
3.4%
5/145 • Number of events 6 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
General disorders
Pain
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
0.00%
0/145 • 3 months for Study period, up to 3 years for Continued Access period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.66%
1/151 • Number of events 1 • 3 months for Study period, up to 3 years for Continued Access period.
|
3.4%
5/145 • Number of events 5 • 3 months for Study period, up to 3 years for Continued Access period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60