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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

240 participants

Primary outcome timeframe

3 months

Results posted on

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at the beginning, with 14 (5 with age 7-17 and 9 with age 18-80) screen failure, 3 subjects with age 7-17 early withdrawn prior the study period, 223 subjects (107 with age 7-17 and 116 with age 18-80) started the study and became the Intention to Treat Population.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

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

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

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 months

Population: 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

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 period

Population: 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

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 period

Population: 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

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 period

Population: 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

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

Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths

Subjects 18-80 Years of Age Study Period

Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 8052089091

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60