Type 2 DiabetesIMPaCT2NCT04721158

CGM Use in Children With Type 2 Diabetes

A study testing Continuous glucose monitor in people with Type 2 Diabetes and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control. Read more about this study

Who is it for?: Ages 5 to 21 years
Conditions the study is for: Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus
What is being tested?: Continuous glucose monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: 17 Jan 2021to 28 Jul 2022
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 5 to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Type 2 diabetes, diabetes duration >3 months

Who cannot join

Prior use of CGM

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes

Read the detailed description

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.

Conditions: Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus
Being tested: Continuous glucose monitor
Keywords: continuous glucose monitoring (CGM), Hemoglobin A1c
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
Also called Dexcom G6 CGM
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.

Study groups in NCT04721158
Study group	Role	What they receive
CGM Arm	Other	Children with type 2 diabetes will wear a continuous glucose monitor for 10 days. Receives: Device: Continuous glucose monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Time in Range Glucose Control
The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL
Measured: 5 days, 10 days
Hemoglobin A1c
HbA1c at baseline and 3-6 month follow-up.
Measured: Baseline, 3 - 6 months
More Frequent Insulin Administration
Response to "Did you take your insulin more often than before?"
Measured: 10 days from CGM placement
More Frequent Glycemic Control Monitoring
Response to "Do you look at or check your blood sugar more often than before?"
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 202128 Jul 2022

First posted22 Jan 2021
Study start17 Jan 2021
Primary completion28 Jul 2022
Study completion28 Jul 2022

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 Johns Hopkins 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04721158
Sponsor's protocol ID: IRB00255470-2
Acronym: IMPaCT2
Status last verified: Aug 2023
First submitted: 19 Jan 2021
Last updated: 15 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Phu A, Lin T, Manfredo JA, Brown EA, Wolf RM. Similar Perceptions on Continuous Glucose Monitor Use amongst Youth with Type 1 and Type 2 Diabetes. Pediatr Diabetes. 2023 Jun 19;2023:1979635. doi: 10.1155/2023/1979635. eCollection 2023.
PubMed 40303266

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
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MTM2MTG Pilot Ancillary Study
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IMPlementation of Continuous Glucose Monitoring in Children With Type 2 Diabetes
ClinicalTrials.gov ID: NCT04721158
Acronym / sponsor ID: IMPaCT2 / IRB00255470-2
Conditions: Type 2 Diabetes, Hyperglycemia Due to Type 2 Diabetes Mellitus
Keywords: continuous glucose monitoring (CGM), Hemoglobin A1c
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 17 Jan 2021 (actual)
Primary completion: 28 Jul 2022 (actual)
Study completion: 28 Jul 2022 (actual)
First posted: 22 Jan 2021 (actual)
Results: Posted 3 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CGM Arm	Other	Device: Continuous glucose monitorChildren with type 2 diabetes will wear a continuous glucose monitor for 10 days.

Who may qualify

Ages: 5 to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Type 2 diabetes, diabetes duration >3 months

Key exclusion criteria (1 listed)

Prior use of CGM

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 monitorAlso: Dexcom G6 CGMEligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.	Device	CGM Arm

Primary outcome

Percentage of Time in Range Glucose Control
Time frame: 5 days, 10 days
The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL
Hemoglobin A1c
Time frame: Baseline, 3 - 6 months
HbA1c at baseline and 3-6 month follow-up.
More Frequent Insulin Administration
Time frame: 10 days from CGM placement
Response to "Did you take your insulin more often than before?"
More Frequent Glycemic Control Monitoring
Time frame: 10 days
Response to "Do you look at or check your blood sugar more often than before?"

Results and safety

Results posted to the registry on 3 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CGM Sample Given	41	36

Primary outcome: Percentage of Time in Range Glucose Control

Time frame: 5 days, 10 days. Mean (Standard Deviation). Unit: percentage of time in target range

Measure	CGM Sample Given n = 18
5 days	49.2 (38)
10 days	50.7 (39)

Population analysed: Participants with CGM use at both 5-days and 10-days

Primary outcome: Hemoglobin A1c

Time frame: Baseline, 3 - 6 months. Mean (Standard Deviation). Unit: percentage of glycosylated hemoglobin A1

Measure	CGM Sample Given n = 30
Baseline	10.2 (2.8)
3-6 months	10.3 (3.2)

Population analysed: Participants with A1c available at baseline and 3-6 months

Primary outcome: More Frequent Insulin Administration

Time frame: 10 days from CGM placement. Count of participants. Unit: Participants

Measure	CGM Arm n = 24
Yes	14
No	8
Sometimes	2

Population analysed: Participants with 10 day follow up surveys

Primary outcome: More Frequent Glycemic Control Monitoring

Time frame: 10 days. Count of participants. Unit: Participants

Measure	CGM Arm n = 24
Yes	23
No	0
Sometimes	1

Population analysed: Participants who responded to the survey conducted at 10 day follow up.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CGM Arm	2 of 41 (4.9%)	0 of 41 (0%)	0 of 41

Limitations and caveats (from the sponsor): The limitations of this study include the small study size with a limited number of participants completing both 10-day trial period and 3/6-month follow up visits. There were a large number of patients who had device connectivity and adhesive issues. Many participants were lost to follow up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40303266Phu A, Lin T, Manfredo JA, Brown EA, Wolf RM. Similar Perceptions on Continuous Glucose Monitor Use amongst Youth with Type 1 and Type 2 Diabetes. Pediatr Diabetes. 2023 Jun 19;2023:1979635. doi: 10.1155/2023/1979635. eCollection 2023.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes

Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Cochlear Synaptopathy
Not yet recruitingPhase 1
A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes
Diabetes Mellitus, Type 2

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.

Risa M Wolf, MD principal investigator

Johns Hopkins School of Medicine

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 in people with Type 2 Diabetes and Hyperglycemia Due to Type 2 Diabetes Mellitus, run by Johns Hopkins 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 1 inclusion and 1 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 15 Sep 2023. 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 3 Aug 2023). 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?

Percentage of Time in Range Glucose Control (time frame: 5 days, 10 days). The study lists 4 primary outcomes in all. 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 NCT04721158, 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 15 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.