Trial Outcomes & Findings for Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children (NCT NCT01823341)

Last Updated: 2016-08-30

Results Overview

Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL (3.9 mmol/L). The time period for outcome assessment each night will be from the time the system is activated in the evening until the time it is deactivated in the morning. The percentage of hypoglycemic nights (CGM glucose value ≤70 mg/dL (3.9 mmol/L)) will be tabulated separately with versus without the closed-loop control system in use. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.

Results posted on

2016-08-30

Participant Flow

The study was conducted at Stanford University (Stanford, CA), the Barbara Davis Center (Denver, CO), and Children's Hospital, London Health Sciences Centre (London, ON). A total of 53 subjects 11-14 years old and 44 subjects 4-10 years old were enrolled. Forty-five of the 11-14 year old subjects and 37 of the 4-10 year old subjects completed.

After the run-in phase, a 42-night randomized trial was conducted in which each night was randomly assigned to have either predictive low glucose suspend system active (intervention) or inactive (control) with half of the nights being intervention and half control nights.

Participant milestones

Participant milestones
Measure	Randomized Nights- Treatment or Control Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
Overall Study STARTED	97
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Nights- Treatment or Control Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
Overall Study Failed run-in	7
Overall Study Withdrawal by Subject	7
Overall Study Adverse Event	1

Baseline Characteristics

Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Nights- Treatment or Control n=82 Participants Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
Age, Customized 11-14 Year olds	13 years n=5 Participants
Age, Customized 4-10 Year olds	8 years n=5 Participants
Sex/Gender, Customized Male Participants 11-14 year old age group	25 participants n=5 Participants
Sex/Gender, Customized Female Participants 11-14 year old age group	20 participants n=5 Participants
Sex/Gender, Customized Male Participants 4-10 year old age group	17 participants n=5 Participants
Sex/Gender, Customized Female Participants 4-10 year old age group	20 participants n=5 Participants
Race/Ethnicity, Customized White non-Hispanic Participants 11-14 years old	43 participants n=5 Participants
Race/Ethnicity, Customized Hispanic Participants 11-14 years old	1 participants n=5 Participants
Race/Ethnicity, Customized Asian Participants 11-14 years old	1 participants n=5 Participants
Race/Ethnicity, Customized White non-Hispanic Participants 4-10 years old	35 participants n=5 Participants
Race/Ethnicity, Customized Hispanic Participants 4-10 years old	2 participants n=5 Participants
Race/Ethnicity, Customized Asian Participants 4-10 years old	0 participants n=5 Participants
Diabetes Duration Participants 11-14 years old	6 years n=5 Participants
Diabetes Duration Participants 4-10 years old	3 years n=5 Participants
Body-mass index percentile (BMI) Participants 11-14 years old	69 BMI Percentile n=5 Participants
Body-mass index percentile (BMI) Participants 4-10 years old	69 BMI Percentile n=5 Participants
HbA1c (%) Participants 11-14 years old	7.7 Percent n=5 Participants
HbA1c (%) Participants 4-10 years old	7.8 Percent n=5 Participants
HbA1c (mmol/mol) Participants 11-14 years old	61 mmol/mol n=5 Participants
HbA1c (mmol/mol) Participants 3-10 years old	62 mmol/mol n=5 Participants
Daily insulin dose (U/kg/day) Participants 11-14 years old	0.83 U/kg/day n=5 Participants
Daily insulin dose (U/kg/day) Participants 4-10 years old	0.76 U/kg/day n=5 Participants

PRIMARY outcome

Timeframe: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.

Population: One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for \<80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.

Outcome measures

Outcome measures
Measure	Pump Suspension Algorithm (Participants 11-14 Years) n=955 Number of Nights Analyzed The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.	Standard of Care (Participants 11-14 Years) n=941 Number of Nights Analyzed The control algorithm will run passively and not recommend control the patient's pump.	Pump Suspension Algorithm (Participants 4-10 Years) n=769 Number of Nights Analyzed The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.	Standard of Care (Participants 4-10 Years) n=755 Number of Nights Analyzed The control algorithm will run passively and not recommend control the patient's pump.
Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.	4.6 percentage of time Interval 2.9 to 7.3	10.1 percentage of time Interval 5.9 to 13.8	3.1 percentage of time Interval 1.6 to 5.0	6.2 percentage of time Interval 3.0 to 7.6

SECONDARY outcome

Timeframe: Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.

Population: One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for \<80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected.

Please note we considered nights with at least 4 hours of sensor glucose data as a "valid" night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected.