Type1diabetesNCT03297762
Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes
A study testing gamification and Use of Dexcom G5 in people with Type1diabetes, run by Stanford University at 1 site in United States.
Trial summary
To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- gamification and Use of Dexcom G5
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- type 1 diabetes for more than 6 months
- on insulin pump or multiple daily injections without plans to change modality in next 6 months
- insured by CCS or Medi-Cal
- receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics
- English or Spanish-speaking
Who cannot join
- major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy
- current oral glucocorticoid use
- prior use of a CGM system
- hemoglobin A1C <7.5% or >12%
- no wireless internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Adherence to Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes
To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D).
Read the detailed description
The investigators will use an automated data integration system to monitor hours per week the CGM is worn and target interventions/troubleshooting techniques as needed. The investigators will use gamification techniques (i.e. ability to gain points and achieve small rewards) to help encourage CGM use and potentially improve glycemic control in this at-risk population.
- Conditions
- Type1diabetes
- Being tested
- gamification, Use of Dexcom G5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamificationBehavioural
incentives/rewards and contact between standard visits
Use of Dexcom G5Behavioural
Dexcom G5 continuous glucose monitor
| Study group | Role | What they receive |
|---|---|---|
| Gamification | Experimental | Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use. Receives: Behavioral: gamification; Behavioral: Use of Dexcom G5 |
| Standard care | Active comparator | Use of continuous glucose monitor (Dexcom G5) per usual care. Receives: Behavioral: Use of Dexcom G5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM use
amount of time per week CGM is used
Measured: baseline to 6 months
Secondary outcomes (1)
Hgb A1c
glycemic control as measured by Hgb A1c
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start7 May 2018
- Primary completion1 May 2019
- Study completion1 Jun 2019
Why it stopped: Enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrell M Wilson, Stanford University
- Investigators
- Maria Chang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297762
- Sponsor's protocol ID
- IRB-36423
- Status last verified
- Apr 2020
- First submitted
- 25 Sep 2017
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03297762
- Acronym / sponsor ID
- IRB-36423
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To use an enhanced continuous glucose monitor (CGM) experience, including an automated CGM-electronic health record (EHR) data integration system, proactive interventions, and gamification techniques, to increase CGM use among publicly-insured youth with type 1 diabetes (T1D).
Detailed description
The investigators will use an automated data integration system to monitor hours per week the CGM is worn and target interventions/troubleshooting techniques as needed. The investigators will use gamification techniques (i.e. ability to gain points and achieve small rewards) to help encourage CGM use and potentially improve glycemic control in this at-risk population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamification | Experimental | Behavioral: gamification, Behavioral: Use of Dexcom G5Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use. |
| Standard care | Active comparator | Behavioral: Use of Dexcom G5Use of continuous glucose monitor (Dexcom G5) per usual care. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- type 1 diabetes for more than 6 months
- on insulin pump or multiple daily injections without plans to change modality in next 6 months
- insured by CCS or Medi-Cal
- receiving care at Lucile Packard Children's Hospital or Stanford Children's Health outpatient clinics
- English or Spanish-speaking
Key exclusion criteria (5 listed)
- major illness or condition that may alter glucose control or ability to complete the study including pregnancy, cystic fibrosis, cancer, liver disease, history of transplant, or hemoglobinopathy
- current oral glucocorticoid use
- prior use of a CGM system
- hemoglobin A1C <7.5% or >12%
- no wireless internet access
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 |
|---|---|---|
| gamificationincentives/rewards and contact between standard visits | Behavioural | Gamification |
| Use of Dexcom G5Dexcom G5 continuous glucose monitor | Behavioural | Gamification, Standard care |
Primary outcome
CGM use
Time frame: baseline to 6 months
amount of time per week CGM is used
1 secondary outcome
Hgb A1c
Time frame: baseline to 6 months
Results and safety
The study was stopped early (reason given: Enrollment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- 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.
Maria Chang, 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 gamification and Use of Dexcom G5 in people with Type1diabetes, 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 Apr 2020. 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?
The study was stopped early (reason given: Enrollment challenges). Results are not available in the source record.
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?
CGM use (time frame: baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.