Trial Outcomes & Findings for Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study (NCT NCT05074667)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)

Results posted on

2024-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitor Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Overall Study STARTED	30
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous Glucose Monitor Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Overall Study Death	1
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	10

Baseline Characteristics

Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitor n=30 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Age, Continuous	15.19 years STANDARD_DEVIATION 2.48 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian and Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	27 Participants n=5 Participants
Race/Ethnicity, Customized Non Hispanic Black	1 Participants n=5 Participants
Race/Ethnicity, Customized Non Hispanic White	1 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)

Population: Participants with available CGM data at each respective timepoint

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=24 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use 2-month visit	7 Participants
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use 3-month visit	2 Participants
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use 6-month visit	1 Participants
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use 9-month visit	0 Participants
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use 12-month visit	0 Participants

SECONDARY outcome

Timeframe: baseline and months 2,3,6,9 and 12

Population: Participants with available data at each respective timepoint

HbA1C through 12 months of CGM use

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=30 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Mean HbA1C baseline	10.18 percentage of glycosylated hemoglobin Standard Deviation 2.65
Mean HbA1C 2-month visit	10.16 percentage of glycosylated hemoglobin Standard Deviation 2.69
Mean HbA1C 3-month visit	8.95 percentage of glycosylated hemoglobin Standard Deviation 2.91
Mean HbA1C 6-month visit	9.27 percentage of glycosylated hemoglobin Standard Deviation 2.71
Mean HbA1C 9-month visit	10.04 percentage of glycosylated hemoglobin Standard Deviation 2.214
Mean HbA1C 12-month visit	9.77 percentage of glycosylated hemoglobin Standard Deviation 1.22

SECONDARY outcome

Timeframe: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)

Population: Participants with available CGM data at each respective timepoint

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=24 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Time With Glucose Values in Target Range of 70-180 mg/dL 9-month visit	28.5 percentage of time Interval 7.5 to 53.75
Time With Glucose Values in Target Range of 70-180 mg/dL 2-month visit	71 percentage of time Interval 18.0 to 93.25
Time With Glucose Values in Target Range of 70-180 mg/dL 3-month visit	45.5 percentage of time Interval 11.25 to 87.75
Time With Glucose Values in Target Range of 70-180 mg/dL 6-month visit	59 percentage of time Interval 37.0 to 86.0
Time With Glucose Values in Target Range of 70-180 mg/dL 12-month visit	42 percentage of time Interval 31.0 to 77.0

SECONDARY outcome

Timeframe: baseline, months 3 and 12

Population: Participants with available data at each respective timepoint

PROMIS Global Health (7 questions, Minimum=1, maximum=5 for each question, higher score for physical health questions is better outcome, higher score for mental health is worse outcome). Scores for each question were summed then converted to a t-score (overall range 16 to 67.5, higher score = better health). A score of 50 is the average for the United States general population with a standard deviation of 10. A score below 22 in this study would result in a referral to social work or diabetes psychology.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=30 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
PROMIS Global Health Overall Scale Score baseline	37.20 T-score Interval 30.0 to 40.4
PROMIS Global Health Overall Scale Score 3-month visit	35.60 T-score Interval 32.4 to 38.8
PROMIS Global Health Overall Scale Score 12-month visit	32.40 T-score Interval 29.2 to 35.6

SECONDARY outcome

Timeframe: baseline and months 3 and 12

Population: Participants with available data at each respective timepoint

Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by participants to create an overall score range of 0 to 100, higher scores correspond to lower problems.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=30 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
PedsQL 3.2 Overall Scale Score - Participant Rated Peds QL Diabetes - baseline	58.33 score on a scale Interval 50.0 to 71.67
PedsQL 3.2 Overall Scale Score - Participant Rated Peds QL Diabetes - month 3	65.00 score on a scale Interval 55.83 to 72.92
PedsQL 3.2 Overall Scale Score - Participant Rated Peds QL Diabetes - month 12	58.33 score on a scale Interval 45.0 to 69.58
PedsQL 3.2 Overall Scale Score - Participant Rated Peds QL Overall - baseline	65.53 score on a scale Interval 58.33 to 71.97
PedsQL 3.2 Overall Scale Score - Participant Rated Peds QL Overall - month 3	59.85 score on a scale Interval 56.82 to 72.92
PedsQL 3.2 Overall Scale Score - Participant Rated Peds QL Overall - month 12	55.30 score on a scale Interval 52.84 to 65.72

SECONDARY outcome

Timeframe: baseline and months 3 and 12

Population: Participants with available data at each respective timepoint

Pediatric Quality of Life Inventory (PedsQL) Diabetes Module version 3.2, including 33 items (questions) comprising 5 dimensions (diabetes symptoms, treatment 1, treatment 2, worry, and communication). Each item scored from 0 to 4, higher scores correspond to lower problems. Each item is reversed scored and linearly transformed to a 0 to 100 scale (0=100,1=75,2=50,3=25,4=0), higher scores correspond to lower problems. The overall score is calculated as the sum of the transformed scores for each item divided by the total number of items answered by parents to create an overall score range of 0 to 100, higher scores correspond to lower problems. Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=19 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
PedsQL 3.2 Scale Score - Parent Rated Peds QL Diabetes - baseline	65.00 score on a scale Interval 61.67 to 73.33
PedsQL 3.2 Scale Score - Parent Rated Peds QL Diabetes - month 3	60.00 score on a scale Interval 55.83 to 68.33
PedsQL 3.2 Scale Score - Parent Rated Peds QL Diabetes - month 12	59.17 score on a scale Interval 54.58 to 72.08
PedsQL 3.2 Scale Score - Parent Rated Peds QL Overall - baseline	64.39 score on a scale Interval 56.06 to 70.76
PedsQL 3.2 Scale Score - Parent Rated Peds QL Overall - month 3	59.85 score on a scale Interval 50.76 to 68.94
PedsQL 3.2 Scale Score - Parent Rated Peds QL Overall - month 12	57.58 score on a scale Interval 52.84 to 73.86

SECONDARY outcome

Timeframe: 1 year (assessed at baseline, 3 months and 12 months)

Population: Participants with available data at each respective timepoint

The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=28 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Diabetes Technology Attitudes (DTA) - Participant Rated baseline	3.78 score on a scale Interval 3.55 to 4.25
Diabetes Technology Attitudes (DTA) - Participant Rated 3-month visit	4.50 score on a scale Interval 3.65 to 4.95
Diabetes Technology Attitudes (DTA) - Participant Rated 12-month visit	4.00 score on a scale Interval 3.75 to 4.55

SECONDARY outcome

Timeframe: 1 year (assessed at baseline, 3 months and 12 months)

Population: Participants with available data at each respective timepoint

The DTA assesses use and comfort with technology. Each of the 5 items are responded to on a 5 point likert scale (from 1=Strongly Disagree to 5=Strongly Agree) Mean item score, higher score = more positive attitude, total score range 1-5 Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=19 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Diabetes Technology Attitudes (DTA) - Parent Rated baseline	3.80 score on a scale Interval 3.4 to 3.8
Diabetes Technology Attitudes (DTA) - Parent Rated 3-month visit	4.00 score on a scale Interval 3.6 to 4.5
Diabetes Technology Attitudes (DTA) - Parent Rated 12-month visit	3.60 score on a scale Interval 3.35 to 4.05

SECONDARY outcome

Timeframe: baseline, months 3 and 12

Population: Participants who completed the PAID Teen survey

Problem Areas in Diabetes - survey Teen version with 14 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 14 to 84 (higher score is worse outcome).

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=20 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated baseline	43.50 score on a scale Interval 30.75 to 47.0
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated 3-month visit	47.00 score on a scale Interval 34.25 to 62.5
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated 12-month visit	52.00 score on a scale Interval 40.5 to 60.5

SECONDARY outcome

Timeframe: baseline, months 3 and 12

Population: Participants with available data at each respective timepoint

Problem Areas in Diabetes - survey Teen Parent version with 15 questions each scored using a 6-point Likert Scale (1=not a problem, to 6=serious problem). The overall score is computed by summing responses for an overall range of 15 to 90 (higher score is worse outcome). Parents completed the survey at the same time as their child but were not considered to be enrolled in the study.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor n=19 Participants Participants are provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care. Participants and their parents are asked to complete patient reported outcome questionnaires at 3 study time points.
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated baseline	55.00 score on a scale Interval 46.0 to 69.5
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated 3-month visit	59.00 score on a scale Interval 48.5 to 69.0
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated 12-month visit	50.50 score on a scale Interval 42.75 to 68.0

Adverse Events

Continuous Glucose Monitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sejal Shah, MD

Stanford University

Phone: 650-498-7351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place