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NCT Number: NCT05074667

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Children's Health

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • public insurance
  • between ages 4-19.99 years inclusive
  • diagnosis of T2D (diabetes autoantibody negative) followed in the Pediatric Endocrinology clinic at Stanford Children's Health
  • HbA1C greater than 6.5% at enrollment
  • interested in starting on a continuous glucose monitor
  • have access to a mobile device that is compatible with CGM applications or willing to use CGM receiver provided

Exclusion criteria

  • non-T2D diagnosis
  • HgA1C < 6.5%
  • are not willing to wear CGM
  • have private health insurance.

Treatment and study plan

Continuous Glucose Monitor

Device

Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care

Patient Reported Outcome Questionnaires

Other

Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.

Primary outcomes

  1. Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use

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

Secondary outcomes

  1. Mean HbA1C

    Time frame: baseline and months 2,3,6,9 and 12

    HbA1C through 12 months of CGM use

  2. Time With Glucose Values in Target Range of 70-180 mg/dL

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

  3. PROMIS Global Health Overall Scale Score

    Time frame: 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.

  4. PedsQL 3.2 Overall Scale Score - Participant Rated

    Time frame: 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 of 0 to 100, higher scores correspond to lower problems.

  5. PedsQL 3.2 Scale Score - Parent Rated

    Time frame: 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 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.

  6. Diabetes Technology Attitudes (DTA) - Participant Rated

    Time frame: 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

  7. Diabetes Technology Attitudes (DTA) - Parent Rated

    Time frame: 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.

  8. Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated

    Time frame: 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).

  9. Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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