Trial Outcomes & Findings for Medtronic Minimed Overnight Closed-Loop System (NCT NCT01881009)

NCT ID: NCT01881009

Last Updated: 2019-11-14

Results Overview

Compared to control nights, the percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: Approximately 12 hours
• Results posted on: 2019-11-14

Participant Flow

Recruitment included mailing/emailing/calling to the families who registered the camp sessions when this study was conducted. Other sources of recruitment included chart review, Stanford Peds Endo Facebook page, Stanford Peds Endo website, support groups, department newsletter, clinic visits, and group visits.

Participant milestones

Measure	Inpatient Overnight Overnight evaluation to test safety of the closed-loop system therapy device.	Summer Camp Session Participants were considered to be a single group, receiving the same interventions, either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study. The sensor augmented pump was considered to be the control.
Inpatient Safety Testing (22 Hours) STARTED	16	0
Inpatient Safety Testing (22 Hours) COMPLETED	16	0
Inpatient Safety Testing (22 Hours) NOT COMPLETED	0	0
Summer Camp Session (6 Days) STARTED	0	22
Summer Camp Session (6 Days) COMPLETED	0	21
Summer Camp Session (6 Days) NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Inpatient Overnight Overnight evaluation to test safety of the closed-loop system therapy device.	Summer Camp Session Participants were considered to be a single group, receiving the same interventions, either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study. The sensor augmented pump was considered to be the control.
Summer Camp Session (6 Days) Unable to wear device	0	1

Baseline Characteristics

Medtronic Minimed Overnight Closed-Loop System

Baseline characteristics by cohort

Measure	Inpatient Overnight n=16 Participants Overnight evaluation to test safety of the closed-loop system therapy device.	Summer Camp Session n=21 Participants Participants were considered to be a single group, receiving the same interventions, either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15.2 years STANDARD_DEVIATION 2.5 • n=5 Participants	14.7 years STANDARD_DEVIATION 3.9 • n=7 Participants	14.95 years STANDARD_DEVIATION 3.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	21 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 12 hours

Population: Intention to treat analysis of the summer camp session. 1 participant who withdrew from the summer camp session was excluded from the analysis.

Compared to control nights, the percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.

Outcome measures

Measure	Closed Loop Nights n=55 Nights analyzed (all participants) Data for nights that participants received closed loop controller treatment.	Control Nights n=52 Nights analyzed (all participants) Data for nights that participants received sensor augmented pump treatment.
Target Sensor Glucose 70-150 mg/dl	66.4 percentage of time Standard Deviation 4.2	50.6 percentage of time Standard Deviation 4.3

PRIMARY outcome

Timeframe: Approximately 12 hours

Population: Intention to treat analysis of the inpatient overnight group. 3 participants that did not complete the inpatient overnight are excluded from the analysis.

Percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.

Outcome measures

Measure	Closed Loop Nights n=13 Nights analyzed (all participants) Data for nights that participants received closed loop controller treatment.	Control Nights Data for nights that participants received sensor augmented pump treatment.
Target Sensor Glucose 70-150 mg/dl	63 percentage of time Interval 41.0 to 89.0	—

SECONDARY outcome

Timeframe: Approximately 12 hours

Population: Target sensor glucose 70-180 mb/dl was a secondary outcome for the summer camp group only. 1 participant who withdrew from the summer camp session was excluded from the analysis.

Compared to control nights, the percent of time in the target range of 70-180 mg/dl according to sensor glucose readings.

Outcome measures

Measure	Closed Loop Nights n=55 Nights analyzed (all participants) Data for nights that participants received closed loop controller treatment.	Control Nights n=52 Nights analyzed (all participants) Data for nights that participants received sensor augmented pump treatment.
Target Sensor Glucose 70-180 mg/dl	79.9 percentage of time Standard Deviation 3.8	60.0 percentage of time Standard Deviation 4.0

Adverse Events

Inpatient Overnight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Summer Camp Session

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Inpatient Overnight n=16 participants at risk Overnight evaluation to test safety of the closed-loop system therapy device.	Summer Camp Session n=22 participants at risk Participants were considered to be a single group, receiving the same interventions, either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study.
Metabolism and nutrition disorders Hypoglycemia and hyperglycemia	0.00% 0/16 • On-study adverse events were collected for 22 hours in the Inpatient Overnight group, and for 6 days in the Summer Camp Session group.	95.5% 21/22 • On-study adverse events were collected for 22 hours in the Inpatient Overnight group, and for 6 days in the Summer Camp Session group.

Additional Information

Bruce Buckingham, M.D.

Stanford University

Phone: 408-356-0911

Email: buckingham@stanford.edu

Results disclosure agreements

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