Trial Outcomes & Findings for The Artificial Pancreas in Very Young Children With T1D (NCT NCT03784027)
NCT ID: NCT03784027
Last Updated: 2025-03-27
Results Overview
Between group difference in time spent with sensor glucose levels between 3.9 to 10.0 mmol/l (70 to 180 mg/dl) during the 4 months intervention period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
16-week home stay
Results posted on
2025-03-27
Participant Flow
81 participants were enrolled between 17 May 201 9 and 16 June 2020 at 7 paediatric diabetes centres in the UK, Luxembourg, Austria and Germany.
74 out of 81 enrolled participants were randomised. Of those not randomised two were withdrawn by the site due to safety concerns and five chose not to continue with the study.
Participant milestones
| Measure |
Closed-loop Insulin Delivery (Intervention), Then Sensor-augmented Pump Therapy (Control)
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system for 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
After a washout period of 1-4 weeks, use of sensor-augmented pump therapy for 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
Sensor Augmented Pump Therapy (Control), Then Closed-loop Insulin Delivery (Intervention)
Sensor augmented pump therapy for 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
After a washout period of 1-4 weeks, unsupervised home use of day and night automated hybrid closed loop insulin delivery system for 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
|---|---|---|
|
Period 1
STARTED
|
39
|
35
|
|
Period 1
COMPLETED
|
39
|
34
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
|
Washout
STARTED
|
39
|
34
|
|
Washout
COMPLETED
|
39
|
34
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
39
|
34
|
|
Period 2
COMPLETED
|
39
|
34
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Closed-loop Insulin Delivery (Intervention), Then Sensor-augmented Pump Therapy (Control)
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system for 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
After a washout period of 1-4 weeks, use of sensor-augmented pump therapy for 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
Sensor Augmented Pump Therapy (Control), Then Closed-loop Insulin Delivery (Intervention)
Sensor augmented pump therapy for 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
After a washout period of 1-4 weeks, unsupervised home use of day and night automated hybrid closed loop insulin delivery system for 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
The Artificial Pancreas in Very Young Children With T1D
Baseline characteristics by cohort
| Measure |
Closed-loop Insulin Delivery First, Then Sensor-augmented Pump Therapy
n=39 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system for 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
Following a 1-4 week washout period, use of sensor-augmented pump therapy for 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
Sensor Augmented Pump Therapy First, Then Closed-loop Insulin Delivery
n=35 Participants
Sensor augmented pump therapy for 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
Following a 1-4 week washout period, unsupervised home use of day and night automated hybrid closed loop insulin delivery system for 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
5.6 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
5.6 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
5.6 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Duration of diabetes
|
2.5 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
2.7 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
2.6 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Continuous Glucose Monitor Use
Current
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Continuous Glucose Monitor Use
In past but not current
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Continuous Glucose Monitor Use
Never
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
BMI percentile (age- and sex-adjusted)
|
67.3 percentile
STANDARD_DEVIATION 23.2 • n=5 Participants
|
71.1 percentile
STANDARD_DEVIATION 24.6 • n=7 Participants
|
69.1 percentile
STANDARD_DEVIATION 23.8 • n=5 Participants
|
|
HbA1c at screening
|
7.3 % of glucose linked to haemoglobin
STANDARD_DEVIATION 0.7 • n=5 Participants
|
7.4 % of glucose linked to haemoglobin
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.3 % of glucose linked to haemoglobin
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
HbA1c
|
56.3 mmol/mol
STANDARD_DEVIATION 7.4 • n=5 Participants
|
57 mmol/mol
STANDARD_DEVIATION 7.1 • n=7 Participants
|
56.6 mmol/mol
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Percent of time in glucose range of 70-180 mg/dl
|
61.5 %
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.8 %
STANDARD_DEVIATION 10.9 • n=7 Participants
|
61.2 %
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Continuous glucose monitoring metrics at baseline
Median percent of time with sensor glucose >180mg/dL (%)
|
32.2 percentage of time
n=5 Participants
|
36.7 percentage of time
n=7 Participants
|
34.4 percentage of time
n=5 Participants
|
|
Continuous glucose monitoring metrics at baseline
Median percent of time with sensor glucose >300mg/dL (%)
|
3.4 percentage of time
n=5 Participants
|
3.8 percentage of time
n=7 Participants
|
3.7 percentage of time
n=5 Participants
|
|
Continuous glucose monitoring metrics at baseline
Median percent of time with sensor glucose <70mg/dL (%)
|
4.5 percentage of time
n=5 Participants
|
3.9 percentage of time
n=7 Participants
|
4.4 percentage of time
n=5 Participants
|
|
Continuous glucose monitoring metrics at baseline
Median percent of time with sensor glucose <54mg/dL (%)
|
0.8 percentage of time
n=5 Participants
|
0.6 percentage of time
n=7 Participants
|
0.7 percentage of time
n=5 Participants
|
|
Mean sensor glucose
|
162.1 mg/dL
STANDARD_DEVIATION 21.6 • n=5 Participants
|
162.1 mg/dL
STANDARD_DEVIATION 21.6 • n=7 Participants
|
162.1 mg/dL
STANDARD_DEVIATION 21.6 • n=5 Participants
|
|
Standard deviation of glucose
|
66.6 mg/dL
n=5 Participants
|
66.6 mg/dL
n=7 Participants
|
66.6 mg/dL
n=5 Participants
|
|
Coefficient of variation of glucose
|
42.4 %
n=5 Participants
|
41.1 %
n=7 Participants
|
41.6 %
n=5 Participants
|
|
Median total daily insulin (U/kg/day)
|
0.76 Units/kg/day
n=5 Participants
|
0.77 Units/kg/day
n=7 Participants
|
0.76 Units/kg/day
n=5 Participants
|
PRIMARY outcome
Timeframe: 16-week home stayBetween group difference in time spent with sensor glucose levels between 3.9 to 10.0 mmol/l (70 to 180 mg/dl) during the 4 months intervention period.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl)
|
71.6 Percent of time spent in target range
Standard Deviation 5.9
|
62.9 Percent of time spent in target range
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 16-week home stayPercentage of time spent with sensor glucose readings above target glucose (10.0mmol/l) (180mg/dl)
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Key Endpoint: Time Spent Above Target Glucose (10.0 mmol/l) (180 mg/dl)
|
22.9 Percent of time spent
Interval 19.3 to 27.3
|
31.7 Percent of time spent
Interval 23.4 to 40.1
|
SECONDARY outcome
Timeframe: 16-week home stayHbA1c is measured in % as per NGSP
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Key Endpoint: HbA1c
|
6.6 % of glucose linked to haemoglobin molec
Standard Deviation 0.6
|
7.0 % of glucose linked to haemoglobin molec
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 16 weeksHbA1c, measured using standardized, validated assays, serves as an indicator of long-term glycemic control, reflecting the average blood glucose levels over approximately 3 months.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Key Endpoint: HbA1c
|
49.0 mmol/mol
Standard Deviation 5.9
|
52.8 mmol/mol
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 16-week home stayMean sensor glucose is calculated from CGM readings over the study period to reflect overall glycemic control.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Key Endpoint: Mean Sensor Glucose
|
145.8 mg/dL
Standard Deviation 11.8
|
158.1 mg/dL
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: 16-week home stayPercentage of time spent with sensor glucose readings below target glucose (3.9mmol/l)(70mg/dl)
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Key Endpoint: Time Spent Below Target Glucose (3.9 mmol/l) (70 mg/dl)
|
4.9 Percent of time spent
Interval 3.3 to 6.7
|
4.5 Percent of time spent
Interval 2.9 to 7.3
|
SECONDARY outcome
Timeframe: 16-week home stayStandard deviation of sensor glucose levels
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Standard Deviation
|
58.6 mg/dL
Interval 53.7 to 64.4
|
64.2 mg/dL
Interval 58.1 to 71.9
|
SECONDARY outcome
Timeframe: 16-week home stayCoefficient of variation (percentage) of sensor glucose levels
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Coefficient of Variation (Percentage) of Glucose Levels
|
41 Percent
Interval 39.0 to 43.0
|
41 Percent
Interval 38.0 to 44.0
|
SECONDARY outcome
Timeframe: 16-week home stayPercentage of time spent with glucose levels \< 3.0mmol/l (54 mg/dl)
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Time With Glucose Levels <3.0 mmol/l (54 mg/dl)
|
1.0 Percent of time spent
Interval 0.6 to 1.4
|
0.9 Percent of time spent
Interval 0.4 to 1.6
|
SECONDARY outcome
Timeframe: 16-week home stayPercentage of time spent with glucose levels in significant hyperglycaemia (glucose levels \> 16.7mmol/l) (300mg/dl)
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Time With Glucose Levels in Significant Hyperglycaemia (Glucose Levels > 16.7 mmol/l) (300 mg/dl)
|
2.0 Percent of time spent
Interval 1.2 to 3.1
|
3.1 Percent of time spent
Interval 1.3 to 5.7
|
SECONDARY outcome
Timeframe: 16-week home stayArea under the curve of sensor glucose readings below 3.5mmol/l (63mg/dl). Glucose AUC was calculated by trapezoidal approximation of sensor glucose levels.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
AUC of Glucose Below 3.5 mmol/l (63 mg/dl)
|
0.1 mg*min/dL
Interval 0.0 to 0.1
|
0.1 mg*min/dL
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: 16-week home stayBMI Standard Deviation Score
Outcome measures
| Measure |
Closed-loop Period
n=65 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=68 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
BMI SDS
|
71 Percentile
Standard Deviation 23
|
70 Percentile
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 16-week home stayMedian daily total, basal and bolus insulin use
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Total, Basal, and Bolus Insulin Dose
Total daily insulin use
|
16.9 Units/day
Interval 13.2 to 21.5
|
17.6 Units/day
Interval 13.6 to 20.3
|
|
Total, Basal, and Bolus Insulin Dose
Total daily basal insulin use
|
8.0 Units/day
Interval 5.8 to 10.9
|
5.7 Units/day
Interval 4.0 to 6.9
|
|
Total, Basal, and Bolus Insulin Dose
Total daily bolus insulin use
|
8.6 Units/day
Interval 6.9 to 10.6
|
11.0 Units/day
Interval 9.1 to 13.5
|
SECONDARY outcome
Timeframe: 16-week home stayThis outcome measure records the total number of severe hypoglycaemic episodes-defined as events requiring external assistance-experienced during the study period. Episodes are captured through patient records and clinical confirmation.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Number of Episodes of Severe Hypoglycaemia
|
1 number of events
|
0 number of events
|
SECONDARY outcome
Timeframe: 16-week home stayCount of subjects with at least one severe hypoglycaemic event during the study. Severe events are defined as episodes requiring external assistance.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Number of Subjects Experiencing Severe Hypoglycaemia
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16-week home stayThe incidence of diabetic ketoacidosis (DKA) episodes will be recorded as the number of confirmed events during the study
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Frequency of Diabetic Ketoacidosis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 16-week home stayThe frequency and nature of other adverse events will be recorded throughout the study. All events not directly linked to the intervention will be documented, detailing their onset, duration, severity, and potential relation to the treatment.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Frequency and Nature of Other Adverse Events
Number of participants with no adverse events
|
53 Participants
|
56 Participants
|
|
Frequency and Nature of Other Adverse Events
Number of participants with one adverse event
|
15 Participants
|
12 Participants
|
|
Frequency and Nature of Other Adverse Events
Number of participants with two or more adverse events
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 16-week home stayThis outcome assesses the percentage of time the continuous glucose monitoring (CGM) system is active and delivering valid data.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Percentage of Time of CGM Availability
|
99 Time using CGM (%)
Interval 99.0 to 100.0
|
99 Time using CGM (%)
Interval 99.0 to 100.0
|
SECONDARY outcome
Timeframe: 16-week home stayThis outcome measure determines the percentage of the total study period during which the closed-loop insulin delivery system operates as intended.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Percentage of Time of Closed-loop Operation
|
95 Time using closed-loop (%)
Interval 92.0 to 97.0
|
—
|
SECONDARY outcome
Timeframe: 16-week home stayFrequency and nature of other serious adverse events will be documented, including type, severity, and potential treatment association.
Outcome measures
| Measure |
Closed-loop Period
n=73 Participants
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 Participants
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Frequency and Nature of Other Serious Adverse Events
|
0 Participants
|
1 Participants
|
Adverse Events
Closed-loop Period
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Sensor-augmented Pump Period
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Closed-loop Period
n=73 participants at risk
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 participants at risk
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Endocrine disorders
Severe hypoglycaemia event
|
1.4%
1/73 • Number of events 1 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
0.00%
0/74 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
|
Gastrointestinal disorders
Other serious adverse event.
|
0.00%
0/73 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
1.4%
1/74 • Number of events 1 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
Other adverse events
| Measure |
Closed-loop Period
n=73 participants at risk
Unsupervised home use of day and night automated hybrid closed loop insulin delivery system over 16 weeks.
Intervention: Device: CamAPS FX
CamAPS FX: CamAPS FX closed loop system comprises:
* Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
* Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
* An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
* Cloud upload system to monitor CGM/insulin data
|
Sensor-augmented Pump Period
n=74 participants at risk
Sensor augmented pump therapy over 16 weeks.
Sensor augmented therapy: Study insulin pump and study CGM.
|
|---|---|---|
|
Endocrine disorders
Hyperglycaemia
|
2.7%
2/73 • Number of events 2 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
8.1%
6/74 • Number of events 10 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
|
Infections and infestations
Infection (Cold, UTI, D&V, fever)
|
21.9%
16/73 • Number of events 24 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
14.9%
11/74 • Number of events 16 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
|
Nervous system disorders
Head injury
|
0.00%
0/73 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
1.4%
1/74 • Number of events 1 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
|
Product Issues
Diabetes related
|
2.7%
2/73 • Number of events 2 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
0.00%
0/74 • Over both 16-week study periods (total 32 weeks).
Severe hypoglycaemia was defined as per ISPAD guidance: If the event requires assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject is impaired cognitively to the point that he/she is unable to treat him- or herself, is unable to verbalize his or her needs, is incoherent, disoriented, and/or combative, or experiences seizure or coma.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place