Trial Outcomes & Findings for Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (NCT NCT05224258)
NCT ID: NCT05224258
Last Updated: 2025-06-22
Results Overview
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
COMPLETED
NA
240 participants
3 months
2025-06-22
Participant Flow
240 subjects (115 with age 7-17 and 125 with age 18-80) enrolled at the beginning, with 14 (5 with age 7-17 and 9 with age 18-80) screen failure, 3 subjects with age 7-17 early withdrawn prior the study period, 223 subjects (107 with age 7-17 and 116 with age 18-80) started the study and became the Intention to Treat Population.
Participant milestones
| Measure |
Subjects 7-17 Years of Age
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
116
|
|
Overall Study
COMPLETED
|
103
|
112
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Subjects 7-17 Years of Age
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Parent/Guardian
|
1
|
0
|
|
Overall Study
Study Product No Longer in Use
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
Baseline Characteristics
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
Baseline characteristics by cohort
| Measure |
Subjects 7-17 Years of Age
n=107 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age
n=116 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.0 Years
STANDARD_DEVIATION 2.4 • n=93 Participants
|
48.3 Years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
31.9 Years
STANDARD_DEVIATION 20.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
110 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=93 Participants
|
113 Participants
n=4 Participants
|
195 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=93 Participants
|
105 Participants
n=4 Participants
|
187 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
BMI
|
23.2 kg/m^2
STANDARD_DEVIATION 4.5 • n=93 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 6.2 • n=4 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 6.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention to Treat Population with available data. Three subjects aged 7-17 and two subjects aged 18-80 did not collect A1C at the end of the study period, so 104 subjects aged 7-17 and 114 subjects aged 18-80 were analyzed at end of study period and the change from baseline to end of study period.
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=104 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age
n=114 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
|---|---|---|
|
Primary Safety Endpoint - Change in HbA1c
|
-0.2 Percentage of HbA1c
Standard Deviation 0.7
|
-0.4 Percentage of HbA1c
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Last 6-7 weeks of 3-month study periodPopulation: Intention to Treat Population with available data. One subject aged 7-17 and three subjects aged 18-80 did not have enough SG points at the last 6-7 weeks of the study period, so 106 subjects aged 7-17 and 113 subjects aged 18-80 were analyzed at last 6-7 weeks of study period.
The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]). Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=106 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age
n=113 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
|---|---|---|
|
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
|
65.7 Percentage of Time in Range (TIR 70-180)
Standard Deviation 11.3
|
77.1 Percentage of Time in Range (TIR 70-180)
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population with available data. One subject aged 7-17 and three subjects aged 18-80 did not have enough SG points at the last 6-7 weeks of the study period, so 106 subjects aged 7-17 and 113 subjects aged 18-80 were analyzed at last 6-7 weeks of study period.
The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]). Non-inferiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=106 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age
n=113 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
|---|---|---|
|
Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])
|
0.3 Percentage of Time in Hypoglycemia (< 54
Standard Deviation 0.3
|
0.3 Percentage of Time in Hypoglycemia (< 54
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Last 6-7 weeks of 3 month study periodPopulation: Intention to Treat Population with available data. One subject aged 7-17 and three subjects aged 18-80 did not have enough SG points at the last 6-7 weeks of the study period, so 106 subjects aged 7-17 and 113 subjects aged 18-80 were analyzed at last 6-7 weeks of study period.
The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]).Superiority test.
Outcome measures
| Measure |
Subjects 7-17 Years of Age
n=106 Participants
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age
n=113 Participants
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
|---|---|---|
|
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
|
65.7 Percentage of Time in Range (TIR 70-180)
Standard Deviation 11.3
|
77.1 Percentage of Time in Range (TIR 70-180)
Standard Deviation 9.6
|
Adverse Events
Subjects 7-17 Years of Age Study Period
Subjects 18-80 Years of Age Study Period
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects 7-17 Years of Age Study Period
n=107 participants at risk
Subjects with insulin-requiring type 1 diabetes age 7-17 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
Subjects 18-80 Years of Age Study Period
n=116 participants at risk
Subjects with insulin-requiring type 1 diabetes age 18-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
MiniMed 780G System: 780G System used with Insulin Fiasp® (Insulin Aspart Injection)
|
|---|---|---|
|
Gastrointestinal disorders
Coeliac disease
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Influenza like illness
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Infusion site pain
|
0.93%
1/107 • Number of events 3 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Infusion site rash
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Infusion site reaction
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site irritation
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site mass
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site pain
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site rash
|
0.93%
1/107 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
1.7%
2/116 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Medical device site reaction
|
0.93%
1/107 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
General disorders
Pyrexia
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Bronchitis
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
COVID-19
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
4.3%
5/116 • Number of events 5 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Cystitis
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Gastroenteritis
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Influenza
|
2.8%
3/107 • Number of events 3 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Infusion site infection
|
2.8%
3/107 • Number of events 3 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Medical device site cellulitis
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
5/107 • Number of events 6 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Otitis media
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.9%
2/107 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Rhinovirus infection
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Sinusitis
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
1.7%
2/116 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Upper respiratory tract infection
|
0.93%
1/107 • Number of events 3 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Infections and infestations
Viral infection
|
3.7%
4/107 • Number of events 4 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Metabolism and nutrition disorders
Acetonaemia
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.8%
3/107 • Number of events 5 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/107 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.86%
1/116 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/107 • Number of events 2 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.93%
1/107 • Number of events 1 • 3-month Study Period
Only Adverse Events during the study period were posted
|
0.00%
0/116 • 3-month Study Period
Only Adverse Events during the study period were posted
|
Additional Information
Thomas Troub, Sr Clinical Research Program Manager
Medtronic Diabetes
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60