Type 1 DiabetesIMPaCTNCT04721145
CGM Use in Poorly Controlled Youth With Type 1 Diabetes
A study testing Dexcom G6 Continuous Glucose Monitor in people with Type 1 Diabetes and Hypoglycemia, run by Johns Hopkins University at 1 site in United States.
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 high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia, High Blood Sugar
- What is being tested?
- Dexcom G6 Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 28 Jun 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
- Diagnosis of Type 1 diabetes for >3 months
Who cannot join
- CGM use in the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Pediatric Diabetes Center
Baltimore, Maryland, 21287
About this study
Official title: IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes
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 high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.
- Conditions
- Type 1 Diabetes, Hypoglycemia, High Blood Sugar
- Being tested
- Dexcom G6 Continuous Glucose Monitor
- Keywords
- Continuous Glucose Monitoring, Time in range, Hemoglobin A1c
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 Continuous Glucose MonitorDevice
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Experimental | Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. Receives: Device: Dexcom G6 Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Personal CGM Use
Evaluate whether there is any change in uptake of personal CGM after 10-day trial.
Measured: Baseline and 3 months
Secondary outcomes (3)
Change in the Percent Time in Range Glucose Control
Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM
Measured: 1-5 days and 6-10 days
Change in Hemoglobin A1c
Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit
Measured: Baseline, 3-6 months
Using Personal CGM
Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Jan 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 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 (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Risa Wolf, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721145
- Sponsor's protocol ID
- IRB00255470
- Acronym
- IMPaCT
- Status last verified
- Jul 2023
- First submitted
- 19 Jan 2021
- Last updated
- 4 Aug 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 40303266Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.
PubMed 36223197
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPaCT: IMPlementing Continuous Glucose Monitoring in High-risk, Poorly Controlled Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04721145
- Acronym / sponsor ID
- IMPaCT / IRB00255470
- Conditions
- Type 1 Diabetes, Hypoglycemia, High Blood Sugar
- Keywords
- Continuous Glucose Monitoring, Time in range, Hemoglobin A1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 4 Aug 2023
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 prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Experimental | Device: Dexcom G6 Continuous Glucose MonitorChildren with type 1 diabetes will wear a continuous glucose monitor (CGM) 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)
- Diagnosis of Type 1 diabetes for >3 months
Key exclusion criteria (1 listed)
- CGM use in the last 6 months
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 |
|---|---|---|
| Dexcom G6 Continuous Glucose MonitorEligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days. | Device | Dexcom G6 Continuous Glucose Monitor |
Primary outcome
Change in Personal CGM Use
Time frame: Baseline and 3 months
Evaluate whether there is any change in uptake of personal CGM after 10-day trial.
3 secondary outcomes
Change in the Percent Time in Range Glucose Control
Time frame: 1-5 days and 6-10 days
Change in Hemoglobin A1c
Time frame: Baseline, 3-6 months
Using Personal CGM
Time frame: 3-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 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.
- Derived from this study: PubMed 36223197Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7.
- Individual participant dataSharing planned: No
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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.
Risa Wolf, MD principal investigator
Johns Hopkins 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 Dexcom G6 Continuous Glucose Monitor in people with Type 1 Diabetes and Hypoglycemia, 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 4 Aug 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 4 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?
Change in Personal CGM Use (time frame: Baseline and 3 months). 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 NCT04721145, which also lists 2 linked publications.
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 4 Aug 2023.