Trial Outcomes & Findings for Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM (NCT NCT00760526)

NCT ID: NCT00760526

Last Updated: 2016-10-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 146 participants
• Primary outcome timeframe: 26 weeks
• Results posted on: 2016-10-19

Participant Flow

Recruitment occurred between January 2009 and December 2010 at the 5 participating DirecNet clinical centers.

Prior to randomization, enrolled participants had a run-in period of 6 weeks to optimize glycemic control prior to CGM use. A blinded CGM was then used for 2-4 weeks prior to randomization to familiarize participants and parents with the device and to collect data for assessment of baseline glycemic control.

Participant milestones

Measure	Continuous Glucose Montoring Participants randomized to the CGM (treatment) group were provided with an unblinded CGM device, sensors, and a FreeStyle Flash blood glucose meter and test strips. A Free- Style Navigator was provided unless the participant was already using a Medtronic Paradigm insulin pump, in which case a MiniMed MiniLink REAL-Time Transmitter could be used. Parents were instructed on device use and daily sensor use was encouraged. They were instructed to continue testing with the home blood glucose meter \>=4 times/day and to verify the accuracy of the CGM glucose measurement with the meter before making management decisions. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.	Standard Glucose Monitoring With Home Glucose Meter Participants in the control group were given a FreeStyle Flash blood glucose meter and test strips and asked to perform blood glucose monitoring at least four times daily. Parents were provided with detailed instructions on how to use CGM and meter data to make real-time insulin dose adjustments and on using computer software to retrospectively review the glucose data to alter insulin dosing (if available). Target glucose values were 80-150 mg/dL before meals, 200 mg/dL after meals, 100-150 mg/dL at bedtime, and 80-150 mg/dL overnight.
Overall Study STARTED	74	72
Overall Study COMPLETED	69	68
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM

Baseline characteristics by cohort

Measure	Continuous Glucose Montoring n=74 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=72 Participants Control Group	Total n=146 Participants Total of all reporting groups
Age, Categorical <=18 years	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	7.5 years STANDARD_DEVIATION 1.8 • n=5 Participants	7.5 years STANDARD_DEVIATION 1.7 • n=7 Participants	7.5 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants	72 participants n=7 Participants	146 participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

Population: Excludes five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models

Outcome measures

Measure	Continuous Glucose Montoring n=69 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=68 Participants Control Group
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events	13 participants	19 participants

SECONDARY outcome

Timeframe: 26 weeks

Population: Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.

Outcome measures

Measure	Continuous Glucose Montoring n=73 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=71 Participants Control Group
Number of Severe Hypoglycemic Events Experienced by Participants	3 events	6 events

SECONDARY outcome

Timeframe: 26 weeks

Population: CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data

Percentage of sensors values in range (71 mg/dL to 180 mg/dL)

Outcome measures

Measure	Continuous Glucose Montoring n=62 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=67 Participants Control Group
CGM Glucose Values (mg/dL)	48 percentage of sensor readings Interval 37.0 to 59.0	49 percentage of sensor readings Interval 38.0 to 59.0

SECONDARY outcome

Timeframe: 26 weeks

CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.

Outcome measures

Measure	Continuous Glucose Montoring n=62 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=67 Participants Control Group
Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)	1.5 percentage of sensor readings Interval 0.6 to 3.5	2.1 percentage of sensor readings Interval 0.6 to 5.9

SECONDARY outcome

Timeframe: 26 weeks

Population: CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.

standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.

Outcome measures

Measure	Continuous Glucose Montoring n=74 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=72 Participants Control Group
Measures of Variability: Standard Deviation (SD)	73 mg/dL Interval 65.0 to 87.0	81 mg/dL Interval 68.0 to 92.0

SECONDARY outcome

Timeframe: 26 weeks

Population: CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data

mean absolute rate of change

Outcome measures

Measure	Continuous Glucose Montoring n=74 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=72 Participants Control Group
Measures of Variability: Mean Absolute Rate of Change	0.91 mg/dL per minute Interval 0.8 to 1.0	0.90 mg/dL per minute Interval 0.77 to 1.0

SECONDARY outcome

Timeframe: 26 weeks

Population: CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data

Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55

Outcome measures

Measure	Continuous Glucose Montoring n=74 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=72 Participants Control Group
Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)	144 percentage of median Interval 125.0 to 168.0	145 percentage of median Interval 127.0 to 173.0

SECONDARY outcome

Timeframe: 26 weeks

The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0-100 with higher score denoting more fear. The results reported below are the values at 26 weeks.

Outcome measures

Measure	Continuous Glucose Montoring n=69 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=68 Participants Control Group
Parental Quality of Life Measures: Hypoglycemia Fear Survey	38 units on a scale Standard Deviation 17	42 units on a scale Standard Deviation 19

SECONDARY outcome

Timeframe: 26 weeks

The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.

Outcome measures

Measure	Continuous Glucose Montoring n=69 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=68 Participants Control Group
Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)	44 units on a scale Standard Deviation 17	49 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 26 weeks

The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1-4. Higher score denotes fewer problems in the past month.

Outcome measures

Measure	Continuous Glucose Montoring n=69 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=68 Participants Control Group
Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale	2.7 units on a scale Standard Deviation 0.5	2.4 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 26 weeks

Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)

JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679-684

Outcome measures

Measure	Continuous Glucose Montoring n=69 Participants Treatment group	Standard Glucose Monitoring With a Home Glucose Meter Control Group
Parental Quality of Life Measures: CGM Satisfaction Scale	3.9 units on a scale Standard Deviation 0.5	—

Adverse Events

Continuous Glucose Montoring

Serious events: 6 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Glucose Monitoring With a Home Glucose Meter

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuous Glucose Montoring n=74 participants at risk Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=72 participants at risk Control Group
Infections and infestations Bacteremia	0.00% 0/74	1.4% 1/72 • Number of events 1
Metabolism and nutrition disorders Dehydration	1.4% 1/74 • Number of events 1	0.00% 0/72
Metabolism and nutrition disorders Diabetic ketoacidosis	1.4% 1/74 • Number of events 1	2.8% 2/72 • Number of events 2
Psychiatric disorders Homicidal ideation	1.4% 1/74 • Number of events 1	0.00% 0/72
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/74 • Number of events 1	1.4% 1/72 • Number of events 1
Metabolism and nutrition disorders Hypoglycemia	2.7% 2/74 • Number of events 2	4.2% 3/72 • Number of events 5
Infections and infestations Pharyngotonsillitis	0.00% 0/74	1.4% 1/72 • Number of events 1

Other adverse events

Measure	Continuous Glucose Montoring n=74 participants at risk Treatment group	Standard Glucose Monitoring With a Home Glucose Meter n=72 participants at risk Control Group
Metabolism and nutrition disorders Hypoglycemia	4.1% 3/74 • Number of events 3	8.3% 6/72 • Number of events 7

Additional Information

Katrina Ruedy

Jaeb Center for Health Research

Phone: 813-975-8690

Email: direcnet@jaeb.org

Results disclosure agreements

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