The primary objective of this study is to compare the efficacy and safety of CGM alone and CGM combined with a family behavioral intervention with a control group using home blood glucose monitoring (BGM) alone.
Although prior studies have not demonstrated that continuous glucose monitoring (CGM) use results in improved glycemic control in children \<8 years of age, many of the barriers to CGM efficacy in this age group may have been due to problems in the wearability and accuracy of prior generation devices, as well as to the setting of glycemic targets aimed primarily at preventing hypoglycemia at all costs. There may also be behavioral barriers to consistent and effective CGM use in this age range. The goal of this study is to assess the impact of CGM alone and CGM combined with a family behavioral intervention focused on supporting CGM use on glycemic control in very young children with T1D compared with usual care without CGM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
143
use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
use of CGM alone to assess CGM adherence
Indiana
Indianapolis, Indiana, United States
Time in glucose range 70-180
The primary outcome will be three 2 group comparisons of the change from baseline in the percentage of sensor values in the target range (70-180 mg/dL), in an ANCOVA model adjusted for the baseline value and factors used to stratify randomization with clinical site as a random effect. Seven days of sensor glucose values during the week prior to the 6, 13, 19 and 26 week clinic visits will be used in analysis for the CGM groups to match up with the blinded CGM placed at each visit in the control group. The CGM data will be pooled across each visit where CGM data are collected during follow up for the primary analysis.
Time frame: Up to 26 weeks
HbA1c at 6-months
A secondary outcome is to compare HbA1c at 6-months, adjusted for baseline.
Time frame: 6 Months
% HbA1c <7.0%
Time frame: 6 Months
% HbA1c <7.5%
Time frame: 6 Months
% with relative reduction in HbA1c >=10%
Time frame: 6 Months
% with absolute reduction in HbA1c >=0.5%
Time frame: 6 Months
% with absolute reduction in HbA1c >=1%
Time frame: 6 Months
% with absolute reduction in HbA1c >=1% or HbA1c <7.0%
Time frame: 6 Months
Mean glucose
Time frame: 6 Months
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Glucose variability measured by coefficient of variation
Time frame: 6 Months
% time >180 mg/dl
Time frame: 6 Months
% time >250 mg/dl
Time frame: 6 Months
% time >300 mg/dl
Time frame: 6 Months
Area under the curve 180 mg/dl
Time frame: 6 Months
High blood glucose index (HBGI)
Time frame: 6 Months
% time <54 mg/dl
Time frame: 6 Months
% time <60 mg/dl
Time frame: 6 Months
% time <70 mg/dl
Time frame: 6 Months
Area over the curve 70 mg/dl
Time frame: 6 Months
Low blood glucose index (LBGI)
Time frame: 6 Months
Hypoglycemic events (using <54 mg/dl)
Time frame: 6 Months
WHO-5 Well Being Index
Survey containing 5 questions with possible responses 0-5. The raw score is calculated by summing the responses. The raw score ranges from 0-25. A percentage score ranging from 0 to 100 is obtained by multiplying the raw score by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.
Time frame: 6 Months
Hypoglycemia Fear Survey Total Score
Survey containing 26 questions with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 25 to put on the scale 0-100. A higher score indicates more fear.
Time frame: 6 Months
Hypoglycemia Fear Survey Worry Subscale
Survey containing 26 questions with possible responses 0-4. Worry subscale score is calculated by taking the mean of the non-missing responses to questions 11-26 and multiplying by 25 to put on the scale 0-100. A higher score indicates more fear.
Time frame: 6 Months
Diabetes Technology Questionnaire
Survey containing 30 questions with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 100 to put on the scale 0-100. A higher total score indicates less of a problem.
Time frame: 6 Months
Problem Areas in Diabetes - Parent (PAID-PR)
Survey containing 18 questions with possible responses 0-4. Total score is calculated by reverse scoring each item, then taking the mean of the non-missing responses. The score is then multiplied by 25 to put on the scale 0-100. A higher total score indicates more burden.
Time frame: 6 Months
Diabetes Family Impact Survey
Survey containing 15 questions with possible responses 0-3. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 3 to put on the scale 0-100. A higher total score indicates more negative impact.
Time frame: 6 Months
Satisfaction Questionnaire
Section 2 of the satisfaction questionnaire contains 8 questions for the CGM groups only with possible responses 0-4. Total score is calculated by taking the mean of the non-missing responses and multiplying by 25 to put on the scale 0-100. A higher total score indicates more satisfaction with the study.
Time frame: 6 Months