NCT05074667

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

Completed NA Results posted Last updated 31 July 2024

What this trial tests

NA trial testing Continuous Glucose Monitor in Type 2 Diabetes in 30 participants. Completed in 25 June 2023.

Timeline

1 December 2021

Primary endpoint
25 June 2023

25 June 2023

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	1 December 2021
Primary completion	25 June 2023
Estimated completion	25 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Continuous Glucose Monitor
• Patient Reported Outcome Questionnaires

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Stanford University

Who can join

Adults 4 to 19, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use Primary · months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)

2-month visit

Group	Value	95% CI
Continuous Glucose Monitor	7

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	2

6-month visit

Group	Value	95% CI
Continuous Glucose Monitor	1

9-month visit

Group	Value	95% CI
Continuous Glucose Monitor	0

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	0

Mean HbA1C Secondary · baseline and months 2,3,6,9 and 12

HbA1C through 12 months of CGM use

baseline

Group	Value	95% CI
Continuous Glucose Monitor	10.18	± 2.65

2-month visit

Group	Value	95% CI
Continuous Glucose Monitor	10.16	± 2.69

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	8.95	± 2.91

6-month visit

Group	Value	95% CI
Continuous Glucose Monitor	9.27	± 2.71

9-month visit

Group	Value	95% CI
Continuous Glucose Monitor	10.04	± 2.214

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	9.77	± 1.22

Time With Glucose Values in Target Range of 70-180 mg/dL Secondary · months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)

2-month visit

Group	Value	95% CI
Continuous Glucose Monitor	71	18 – 93.25

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	45.5	11.25 – 87.75

6-month visit

Group	Value	95% CI
Continuous Glucose Monitor	59	37 – 86

9-month visit

Group	Value	95% CI
Continuous Glucose Monitor	28.5	7.5 – 53.75

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	42	31 – 77

PROMIS Global Health Overall Scale Score Secondary · baseline, months 3 and 12

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.

baseline

Group	Value	95% CI
Continuous Glucose Monitor	37.20	30.00 – 40.40

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	35.60	32.40 – 38.80

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	32.40	29.20 – 35.60

PedsQL 3.2 Overall Scale Score - Participant Rated Secondary · baseline and months 3 and 12

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

Peds QL Diabetes - baseline

Group	Value	95% CI
Continuous Glucose Monitor	58.33	50.00 – 71.67

Peds QL Diabetes - month 3

Group	Value	95% CI
Continuous Glucose Monitor	65.00	55.83 – 72.92

Peds QL Diabetes - month 12

Group	Value	95% CI
Continuous Glucose Monitor	58.33	45.00 – 69.58

Peds QL Overall - baseline

Group	Value	95% CI
Continuous Glucose Monitor	65.53	58.33 – 71.97

Peds QL Overall - month 3

Group	Value	95% CI
Continuous Glucose Monitor	59.85	56.82 – 72.92

Peds QL Overall - month 12

Group	Value	95% CI
Continuous Glucose Monitor	55.30	52.84 – 65.72

PedsQL 3.2 Scale Score - Parent Rated Secondary · baseline and months 3 and 12

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

Peds QL Diabetes - baseline

Group	Value	95% CI
Continuous Glucose Monitor	65.00	61.67 – 73.33

Peds QL Diabetes - month 3

Group	Value	95% CI
Continuous Glucose Monitor	60.00	55.83 – 68.33

Peds QL Diabetes - month 12

Group	Value	95% CI
Continuous Glucose Monitor	59.17	54.58 – 72.08

Peds QL Overall - baseline

Group	Value	95% CI
Continuous Glucose Monitor	64.39	56.06 – 70.76

Peds QL Overall - month 3

Group	Value	95% CI
Continuous Glucose Monitor	59.85	50.76 – 68.94

Peds QL Overall - month 12

Group	Value	95% CI
Continuous Glucose Monitor	57.58	52.84 – 73.86

Diabetes Technology Attitudes (DTA) - Participant Rated Secondary · 1 year (assessed at baseline, 3 months and 12 months)

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

baseline

Group	Value	95% CI
Continuous Glucose Monitor	3.78	3.55 – 4.25

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	4.50	3.65 – 4.95

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	4.00	3.75 – 4.55

Diabetes Technology Attitudes (DTA) - Parent Rated Secondary · 1 year (assessed at baseline, 3 months and 12 months)

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.

baseline

Group	Value	95% CI
Continuous Glucose Monitor	3.80	3.40 – 3.80

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	4.00	3.60 – 4.50

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	3.60	3.35 – 4.05

Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated Secondary · baseline, months 3 and 12

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).

baseline

Group	Value	95% CI
Continuous Glucose Monitor	43.50	30.75 – 47.00

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	47.00	34.25 – 62.50

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	52.00	40.50 – 60.50

Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated Secondary · baseline, months 3 and 12

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.

baseline

Group	Value	95% CI
Continuous Glucose Monitor	55.00	46.00 – 69.50

3-month visit

Group	Value	95% CI
Continuous Glucose Monitor	59.00	48.50 – 69.00

12-month visit

Group	Value	95% CI
Continuous Glucose Monitor	50.50	42.75 – 68.00

Sponsor's own description

The purpose of this pilot feasibility study is to provide continued CGM access to youth with type 2 diabetes and collect descriptive data about feasibility of use of CGM in youth with type 2 diabetes ages 4 years and older. From this study the investigators hope to learn if CGM use in youth with type 2 diabetes can be tolerated and sustained with good adherence and to describe blood glucose patterns in youth with type 2 diabetes. The primary aim will be to evaluate the feasibility of CGM start and continuation in youth with T2D and describe glucose metrics and patient reported outcomes (PROs). The investigators will pilot and refine a program to test the hypothesis that CGM start and continuation in youth with T2D is feasible and then evaluate glucose metrics and PROs.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Use of Continuous Glucose Monitors in Publicly Insured Youth With Type 2 Diabetes: A 12-month Pilot and Feasibility Study.
   Shah S, Tanenbaum ML, Loyola A, Sala NGL, et al · · 2025 · PMID 40974209 · DOI 10.1177/19322968251368366