Trial Outcomes & Findings for Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes (NCT NCT02733991)
NCT ID: NCT02733991
Last Updated: 2020-01-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
6 months
Results posted on
2020-01-21
Participant Flow
Participant milestones
| Measure |
Treatment
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
MiniMed™640G alone
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
77
|
|
Overall Study
COMPLETED
|
75
|
72
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Treatment
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
MiniMed™640G alone
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=76 Participants
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
n=77 Participants
MiniMed™640G alone
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=76 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=153 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=76 Participants
|
70 Participants
n=77 Participants
|
135 Participants
n=153 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=76 Participants
|
7 Participants
n=77 Participants
|
18 Participants
n=153 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 12.22 • n=76 Participants
|
47.4 years
STANDARD_DEVIATION 12.53 • n=77 Participants
|
48.2 years
STANDARD_DEVIATION 12.36 • n=153 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=76 Participants
|
38 Participants
n=77 Participants
|
76 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=76 Participants
|
39 Participants
n=77 Participants
|
77 Participants
n=153 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
15 participants
n=76 Participants
|
15 participants
n=77 Participants
|
30 participants
n=153 Participants
|
|
Region of Enrollment
Italy
|
19 participants
n=76 Participants
|
20 participants
n=77 Participants
|
39 participants
n=153 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=76 Participants
|
14 participants
n=77 Participants
|
30 participants
n=153 Participants
|
|
Region of Enrollment
France
|
14 participants
n=76 Participants
|
16 participants
n=77 Participants
|
30 participants
n=153 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=76 Participants
|
12 participants
n=77 Participants
|
24 participants
n=153 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 2 participants in the control arm did not have data.
Outcome measures
| Measure |
Treatment
n=76 Participants
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
n=75 Participants
MiniMed™640G alone
|
|---|---|---|
|
Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
|
1.12 hypoglycaemic events per week
Standard Deviation 1.229
|
4.13 hypoglycaemic events per week
Standard Deviation 3.361
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 2 participants in the control arm did not have data.
Outcome measures
| Measure |
Treatment
n=76 Participants
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
n=75 Participants
MiniMed™640G alone
|
|---|---|---|
|
Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
|
12.85 minutes per day
Standard Deviation 12.741
|
60.08 minutes per day
Standard Deviation 53.644
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 2 participants in the control arm did not have data.
Outcome measures
| Measure |
Treatment
n=76 Participants
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
n=75 Participants
MiniMed™640G alone
|
|---|---|---|
|
Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
|
862.91 minutes per day
Standard Deviation 162.910
|
832.18 minutes per day
Standard Deviation 168.690
|
Adverse Events
Treatment
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=76 participants at risk
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
n=77 participants at risk
MiniMed™640G alone
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenic fever
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Acute sinusitis
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Injury, poisoning and procedural complications
Anterior cruciate ligament tear
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.3%
1/76 • Number of events 2 • 6 months
|
0.00%
0/77 • 6 months
|
Other adverse events
| Measure |
Treatment
n=76 participants at risk
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on
|
Control
n=77 participants at risk
MiniMed™640G alone
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Endocrine disorders
Polyuria-polydipsia syndrome
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Eye disorders
Left cataract
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Eye disorders
Eye ulcer
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Gastrointestinal disorders
Swelling abdomen
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/76 • 6 months
|
2.6%
2/77 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Gastrointestinal disorders
Antibiotic-associated diarrhoea
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/76 • Number of events 1 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
General disorders
Cannula site pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
General disorders
Device intolerance
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
General disorders
Tiredness
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
General disorders
Injection site lump
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
General disorders
Medical device site erythema
|
1.3%
1/76 • Number of events 1 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
General disorders
Medical device site bleeding
|
5.3%
4/76 • Number of events 4 • 6 months
|
3.9%
3/77 • Number of events 3 • 6 months
|
|
General disorders
Medical device site irritation
|
3.9%
3/76 • Number of events 3 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
General disorders
Medical device site pain
|
1.3%
1/76 • Number of events 1 • 6 months
|
2.6%
2/77 • Number of events 2 • 6 months
|
|
General disorders
Medical device site pruritus
|
1.3%
1/76 • Number of events 1 • 6 months
|
2.6%
2/77 • Number of events 2 • 6 months
|
|
General disorders
Medical device site reaction
|
1.3%
1/76 • Number of events 2 • 6 months
|
0.00%
0/77 • 6 months
|
|
General disorders
Edema
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
General disorders
Fever
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/76 • Number of events 1 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Flu syndrome
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Infections and infestations
Kidney infection
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Infections and infestations
Cold
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Common cold
|
2.6%
2/76 • Number of events 4 • 6 months
|
3.9%
3/77 • Number of events 4 • 6 months
|
|
Infections and infestations
Rhinopharyngitis
|
0.00%
0/76 • 6 months
|
2.6%
2/77 • Number of events 2 • 6 months
|
|
Infections and infestations
Belly button infection
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Infections and infestations
Cold sores
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Rhinitis
|
2.6%
2/76 • Number of events 2 • 6 months
|
5.2%
4/77 • Number of events 4 • 6 months
|
|
Infections and infestations
Sinusitis
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Infections and infestations
Tonsillitis
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Injury, poisoning and procedural complications
Fractured toe
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Fractured metacarpal
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Injury, poisoning and procedural complications
Ankle injury
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Wrist injury
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Neck sprain
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Injury, poisoning and procedural complications
Leg injury
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Investigations
Blood glucose fluctuation
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.2%
7/76 • Number of events 9 • 6 months
|
6.5%
5/77 • Number of events 7 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.9%
3/76 • Number of events 3 • 6 months
|
13.0%
10/77 • Number of events 18 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalised joint pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fascitis plantar
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemangioma of liver
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Nervous system disorders
Light headedness
|
1.3%
1/76 • Number of events 1 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Nervous system disorders
Intermittent headache
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Mood disorder NOS
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Psychiatric disorders
Anxiety
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Depression worsened
|
2.6%
2/76 • Number of events 2 • 6 months
|
2.6%
2/77 • Number of events 2 • 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Psychiatric disorders
Stress
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat pain
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Skin and subcutaneous tissue disorders
Allergic skin reaction
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Skin and subcutaneous tissue disorders
Itching both hands
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.6%
2/76 • Number of events 2 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Vascular disorders
Medial sclerosis
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Vascular disorders
Bleeding
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertension worsened
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
|
Vascular disorders
Blood pressure low
|
1.3%
1/76 • Number of events 1 • 6 months
|
0.00%
0/77 • 6 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/76 • 6 months
|
1.3%
1/77 • Number of events 1 • 6 months
|
Additional Information
Ohad Cohen M.D., Medical Affairs Director
Medtronic Diabetes EMEA
Phone: +972 54 321 1108
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60