Trial Outcomes & Findings for Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age (NCT NCT01421225)
NCT ID: NCT01421225
Last Updated: 2018-08-09
Results Overview
Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Participants will be followed for the duration of the 48 hour protocol.
Results posted on
2018-08-09
Participant Flow
Participant milestones
| Measure |
Standard Insulin Pump Therapy First
The subjects in this arm received Standard Insulin Pump therapy on day 1 followed by Closed-Loop Insulin therapy on day 2.
Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol.
|
Closed-Loop Insulin Therapy First
The subjects in this arm receive closed-loop insulin therapy on day 1 followed by standard insulin pump therapy on day 2.
Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Standard Insulin Pump Therapy First
The subjects in this arm received Standard Insulin Pump therapy on day 1 followed by Closed-Loop Insulin therapy on day 2.
Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol.
|
Closed-Loop Insulin Therapy First
The subjects in this arm receive closed-loop insulin therapy on day 1 followed by standard insulin pump therapy on day 2.
Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Closed-Loop Insulin Delivery in Children Less Than 7 Years of Age
Baseline characteristics by cohort
| Measure |
Standard Insulin Pump Therapy First
n=4 Participants
The subjects in this arm received Standard Insulin Pump therapy on day 1 followed by Closed-Loop Insulin therapy on day 2.
Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol.
|
Closed-Loop Insulin Therapy First
n=6 Participants
The subjects in this arm receive closed-loop insulin therapy on day 1 followed by standard insulin pump therapy on day 2.
Closed-loop Insulin therapy: Subjects' insulin dose will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
Standard Insulin Pump Therapy: Patients will receive standard insulin pump therapy as per their usual home insulin protocol.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
age
|
3.7 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.5 years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
5.1 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of the 48 hour protocol.Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=10 Participants
Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2.
|
Closed-Loop Insulin Therapy
n=10 Participants
Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2.
|
|---|---|---|
|
Nocturnal Glycemic Control
|
3.2 Hours
Standard Error 0.77
|
5.3 Hours
Standard Error 0.66
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of the 48 hour protocolPeak post-prandial blood sugar between 8 AM and noon
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=10 Participants
Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2.
|
Closed-Loop Insulin Therapy
n=10 Participants
Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2.
|
|---|---|---|
|
Post-prandial Glycemic Control
|
353 mg/dL
Standard Error 24
|
367 mg/dL
Standard Error 23
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of the 48 hour protocolThe number of interventions for hypoglycemia between 10 PM - 8 AM.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=10 Participants
Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2.
|
Closed-Loop Insulin Therapy
n=10 Participants
Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2.
|
|---|---|---|
|
Number of Interventions for Hypoglycemia
|
4 Interventions
|
5 Interventions
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of the 48 hour protocolBlood glucose levels were documented at 12 pm just prior to being served lunch.
Outcome measures
| Measure |
Standard Insulin Pump Therapy
n=10 Participants
Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2.
|
Closed-Loop Insulin Therapy
n=10 Participants
Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2.
|
|---|---|---|
|
Pre-lunch Blood Glucose Level
|
273 mg/dL
Standard Error 24
|
189 mg/dL
Standard Error 18
|
Adverse Events
Standard Insulin Pump Therapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Closed-Loop Insulin Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Insulin Pump Therapy
n=10 participants at risk
Subjects will receive standard insulin pump therapy as per their usual home insulin protocol on day 1 or 2.
|
Closed-Loop Insulin Therapy
n=10 participants at risk
Subjects insulin doses will be adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon the following day on day 1 or 2.
|
|---|---|---|
|
Metabolism and nutrition disorders
Medication Error
|
10.0%
1/10 • Number of events 1 • Participants will be followed for the duration of the 48 hour protocol.
|
0.00%
0/10 • Participants will be followed for the duration of the 48 hour protocol.
|
Other adverse events
Adverse event data not reported
Additional Information
Garry Steil (Assistant Prof. of Pediatrics)
Boston Children's Hospital
Phone: 617-355-7504
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place