Trial Outcomes & Findings for Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes (NCT NCT02463097)
NCT ID: NCT02463097
Last Updated: 2019-04-16
Results Overview
There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
Baseline and 3 months
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
Study Arm
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Overall Study
STARTED
|
124
|
|
Overall Study
COMPLETED
|
123
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Study Arm
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Study Arm
n=124 Participants
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 16.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsThere is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.
Outcome measures
| Measure |
Study Arm
n=123 Participants
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Change in A1C
|
-0.5 Percent
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 3 monthsThere is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.
Outcome measures
| Measure |
Study Arm
n=124 Participants
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Number of Severe Hypoglycemia Events
|
0 events
|
SECONDARY outcome
Timeframe: 3 monthsThere is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.
Outcome measures
| Measure |
Study Arm
n=124 Participants
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Number of Diabetic Ketoacidosis (DKA) Events
|
0 events
|
Adverse Events
Study Arm
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Arm
n=124 participants at risk
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Bacterial arthritis of right wrist
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Investigations
C-difficile diarrhea
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Musculoskeletal and connective tissue disorders
Worsening Rheumatoid Arthritis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
Other adverse events
| Measure |
Study Arm
n=124 participants at risk
All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm
Insulin Pump: Closed Loop Algorithm
i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation
Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Gastrointestinal disorders
Abdominal pain for few days
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Injury, poisoning and procedural complications
Abrasion to left great toe
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Acute frontal sinusitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Bacterial conjunctivitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Ear and labyrinth disorders
Benign paroxysmal positional vertigo
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Injury, poisoning and procedural complications
Bicycle injury
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Bronchitis
|
1.6%
2/124 • Number of events 2 • 3 Month
|
|
Injury, poisoning and procedural complications
Burn
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Eye disorders
Cataract
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Cold
|
3.2%
4/124 • Number of events 5 • 3 Month
|
|
Infections and infestations
Cold-upper respiratory
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Common cold
|
4.0%
5/124 • Number of events 5 • 3 Month
|
|
Eye disorders
Conjunctivitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Injury, poisoning and procedural complications
Cracked ulna
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Respiratory, thoracic and mediastinal disorders
Deviated septum
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Gastrointestinal disorders
Dyspepsia
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Gastrointestinal disorders
Emesis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Gastrointestinal disorders
Gastro pain (upset stomach), nausea
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Gastroenteritis
|
2.4%
3/124 • Number of events 3 • 3 Month
|
|
Infections and infestations
Gastrointestinal virus
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Head cold
|
2.4%
3/124 • Number of events 3 • 3 Month
|
|
Nervous system disorders
Headache
|
3.2%
4/124 • Number of events 5 • 3 Month
|
|
Gastrointestinal disorders
Heart burn
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.8%
6/124 • Number of events 6 • 3 Month
|
|
General disorders
Infiltration. bruising.
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Nervous system disorders
Intermittent headaches
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Intestinal virus
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
General disorders
Irritation on sensor site
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
General disorders
Iv site pain
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Laryngitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Left leg cellulitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Nervous system disorders
Migraine
|
1.6%
2/124 • Number of events 2 • 3 Month
|
|
Infections and infestations
Mononucleosis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Otitis media
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
General disorders
Pain
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Periodontal infection
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Pharyngitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Metabolism and nutrition disorders
Severe hyperglycemia
|
10.5%
13/124 • Number of events 17 • 3 Month
|
|
Infections and infestations
Sinus infection
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Stomach flu
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Vascular disorders
Thrombophlebitis
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Gastrointestinal disorders
Toothache
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Immune system disorders
Type 4 skin hypersensitivity
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory congestion
|
1.6%
2/124 • Number of events 2 • 3 Month
|
|
Infections and infestations
Upper respiratory infection
|
8.9%
11/124 • Number of events 13 • 3 Month
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
3/124 • Number of events 3 • 3 Month
|
|
Infections and infestations
Urinary tract infection
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Infections and infestations
Uti
|
1.6%
2/124 • Number of events 2 • 3 Month
|
|
Infections and infestations
Viral illness
|
0.81%
1/124 • Number of events 2 • 3 Month
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
1/124 • Number of events 1 • 3 Month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.81%
1/124 • Number of events 1 • 3 Month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60