Type 2 DiabetesNCT05074667
Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
A study testing Continuous Glucose Monitor and Patient Reported Outcome Questionnaires in people with Type 2 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 19 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Continuous Glucose Monitor and Patient Reported Outcome Questionnaires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 25 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- non-T2D diagnosis
- HgA1C < 6.5%
- are not willing to wear CGM
- have private health insurance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Children's Health
Palo Alto, California, 94304
About this 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Continuous Glucose Monitor, Patient Reported Outcome Questionnaires
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
Participants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care
Patient Reported Outcome QuestionnairesOther
Participants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor | Other | All participants will be included in this arm Receives: Device: Continuous Glucose Monitor; Other: Patient Reported Outcome Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least 75% Wear Time Over 14 Days as a Measure of Sustained CGM Use
Measured: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)
Secondary outcomes (9)
Mean HbA1C
HbA1C through 12 months of CGM use
Measured: baseline and months 2,3,6,9 and 12
Time With Glucose Values in Target Range of 70-180 mg/dL
Measured: months 2,3,6,9 and 12 (assessed over the 14 days prior to each clinic visit)
PROMIS Global Health Overall Scale Score
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.
Measured: baseline, months 3 and 12
PedsQL 3.2 Overall Scale Score - Participant Rated
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.
Measured: baseline and months 3 and 12
PedsQL 3.2 Scale Score - Parent Rated
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.
Measured: baseline and months 3 and 12
Diabetes Technology Attitudes (DTA) - Participant Rated
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
Measured: 1 year (assessed at baseline, 3 months and 12 months)
Diabetes Technology Attitudes (DTA) - Parent Rated
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.
Measured: 1 year (assessed at baseline, 3 months and 12 months)
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated
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).
Measured: baseline, months 3 and 12
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated
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.
Measured: baseline, months 3 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Dec 2021
- Primary completion25 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sejal Shah, Stanford University
- Investigators
- Sejal Shah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074667
- Sponsor's protocol ID
- 62166
- Status last verified
- Jul 2024
- First submitted
- 29 Sep 2021
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial after deidentification
Publications
Shah S, Tanenbaum ML, Loyola A, Sala NGL, Darji H, Hanes S, Bishop FK, Hood KK, Maahs DM. Use of Continuous Glucose Monitors in Publicly Insured Youth With Type 2 Diabetes: A 12-month Pilot and Feasibility Study. J Diabetes Sci Technol. 2025 Sep 20:19322968251368366. doi: 10.1177/19322968251368366. Online ahead of print.
PubMed 40974209
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Continuous Glucose Monitors in Publicly-Insured Youth With Type 2 Diabetes - A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT05074667
- Acronym / sponsor ID
- 62166
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor | Other | Device: Continuous Glucose Monitor, Other: Patient Reported Outcome QuestionnairesAll participants will be included in this arm |
Who may qualify
- Ages
- 4 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- non-T2D diagnosis
- HgA1C < 6.5%
- are not willing to wear CGM
- have private health insurance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitorParticipants will be provided a continuous glucose monitor for use in self-glucose monitoring as per standard clinical care | Device | Continuous Glucose Monitor |
| Patient Reported Outcome QuestionnairesParticipants and their parents will be asked to complete patient reported outcome questionnaires at 3 study time points. | Other | Continuous Glucose Monitor |
Primary outcome
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)
9 secondary outcomes
Mean HbA1C
Time frame: baseline and months 2,3,6,9 and 12
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)
PROMIS Global Health Overall Scale Score
Time frame: baseline, months 3 and 12
PedsQL 3.2 Overall Scale Score - Participant Rated
Time frame: baseline and months 3 and 12
PedsQL 3.2 Scale Score - Parent Rated
Time frame: baseline and months 3 and 12
Diabetes Technology Attitudes (DTA) - Participant Rated
Time frame: 1 year (assessed at baseline, 3 months and 12 months)
Diabetes Technology Attitudes (DTA) - Parent Rated
Time frame: 1 year (assessed at baseline, 3 months and 12 months)
Problem Areas in Diabetes-Teen Version (PAID-T) Overall Scale Score - Participant Rated
Time frame: baseline, months 3 and 12
Problem Areas in Diabetes (P-PAID) Overall Scale Score - Parent Rated
Time frame: baseline, months 3 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40974209Shah S, Tanenbaum ML, Loyola A, Sala NGL, Darji H, Hanes S, Bishop FK, Hood KK, Maahs DM. Use of Continuous Glucose Monitors in Publicly Insured Youth With Type 2 Diabetes: A 12-month Pilot and Feasibility Study. J Diabetes Sci Technol. 2025 Sep 20:19322968251368366. doi: 10.1177/19322968251368366. Online ahead of print.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sejal Shah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor and Patient Reported Outcome Questionnaires in people with Type 2 Diabetes, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.