Diabetes Mellitus, Type 2T2HelpNCT04503239
Prediabetes and Type 2 Diabetes Data Collection Study
An observational study of Diabetes Mellitus, Type 2 and Pre-diabetes, run by DexCom, Inc. at 5 sites in United States.
Trial summary
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM, medication and food intake approximately 80% of the time for each subject that completes the entire active phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pre-diabetes
- What is being tested?
- G6
- Type of treatment
- Medical device
- How many people
- 306 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Jul 2020to 27 Feb 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pre-diabetics and Type 2 Diabetics 18 and over willing to wear 2 study devices and enter in the daily medication and food intake.
Who may be able to join
- Subjects ages ≥18 years of age at the time of screening
- High Risk of developing PD or T2D with HbA1c ≤5.6%
- With one or more of the following:
- Strong family history of T2D
- BMI ≥35 kg/m2
- History of gestational diabetes mellitus (GDM)
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- Age and Race, Ethnicity
- Polycistic Ovarian Syndrome
- High Blood Pressure
- Abnormal cholesterol and triglyceride levels
- Clinical Diagnosis of Prediabetes (PD) as defined by ADA to have an HbA1c ≥5.7%-6.4%. or clinical diagnosis of Type 2 Diabetes (T2D) with HbA1c between ≥6.5 % and ≤12.0%. Determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
- Having no treatment, one or more of the combination of treatments for the disease in every spectrum such as exercise and diet for PD and no treatment, 1 or more methods of treatment for T2D and combination of treatments for the disease MDI or CSII alone, MDI or CSII plus OAD and MDI or CSII with or without GLP-1 with or without OAD.
- No change in diabetic medication in the last three months for patients in treatment.
- Willingness to use a study provided CGM, use of an activity tracker, and agree to record data related to food and medication intake in an e-diary (e.g. mobile app).
- For a subset of subjects who agree to provide consent, an OGTT will be performed as explained on Appendix 3. OGTT will be performed on 6 subjects per group that have a lab result with positive c-peptide. Having a smartphone compatible with Dexcom G6 CGM, activity tracker \& e-Diary. (This could be provided by the study team if the qualified subject does not have smartphone compatible with apps. For users that do not use their personal smartphones for data collection purposes, the T2Help study will provide a commercially available smartphone. The smartphones will be modified so they are only capable of hosting and running the study applications required for data collection (Fitbit, Welldoc, G6). The modified smartphones will not be able to execute standard smartphone functionality such as internet browsing, texting, or making phone calls. Bluetooth functionality will remain intact as it is required for the approved applications to collect data.)
- If using additional medication, such as thyroid, hypertension, and cholesterol lowering medication these have to be stable for at least 3 months.
Who cannot join
- Hospital admissions for diabetes ketoacidosis (DKA) or Hyperglycemic Hyperosmolar Nonketotic Syndrome (HHNS) in the last 6 months.
- History of 2 or more episodes of severe hypoglycemia, which resulted in any of the following during the 6 months prior to screening:
- Medical assistance by a third party (Caregiver needed to inject glucagon, ER visit, hospitalization) Coma Seizures
- Subject has a skin condition for which he/she is unable to tolerate tape adhesive in the area of sensor placement.
- Pregnancy (as demonstrated by a positive test at study entry) at time of screening or are planning to become pregnant during the study.
- Subject has had any of the following cardiovascular events within 3 months of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, recent transient ischemic attack, cerebrovascular accident with sequelae, unstable angina, unstable congestive heart failure, unstable ventricular rhythm disturbances or thromboembolic disease.
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- Unstable thyroid disease. (changes in Thyroid medication in the last 90 days)
- Subject has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from the time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study.
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
- Subject is currently using illicit drugs.
- Subject is currently abusing prescription drugs.
- Subject is currently abusing alcohol.
- Subject has a history of visual impairment which would not allow him/her to participate in the study and perform all study procedures safely, as determined by the investigator.
- Subject has elective surgery planned that requires general anesthesia during the course of the study.
- Subject has a sickle cell disease, hemoglobinopathy, or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
- Subject diagnosed with current eating disorder such as anorexia or bulimia.
- Subject is on dialysis.
- Subject has eGFR <45 confirmed by medical record.
- Recent Pancreatitis. (< 30 days)
- Cancer/malignancy in treatment.
- Cystic fibrosis.
- Any other problem for which the investigator or the sponsor may believe that the subject will not be able to comply with the study. (e.g. use of hydroxyurea)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Palm Research Center
Las Vegas, Nevada, 89148
Synergy San Diego
Lemon Grove, California, 91945
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Oregon Health & Science University
Portland, Oregon, 97239
Diabetes and Glandular Disease
San Antonio, Texas, 78229
About this study
Official title: Prediabetes and Type 2 Diabetes Data Collection Study: T2Help
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM, medication and food intake approximately 80% of the time for each subject that completes the entire active phase.
Read the detailed description
In addition, lifestyle and treatment already established for prediabetes and Type 2 Diabetes such as:
- Sleep
- Exercise/Physical activity/or lack of it
- Heart rate
- Five hours OGTT- 6 subjects in each group that have C-Peptide positive lab result at screening and consent to the OGTT (Appendix 3) This data will address the sources and nature of blood glucose variability across the progression of PD and T2D. The data collected in this study will enable investigation into CGM-data artifacts that speak to the state and management of PD and T2D. Possible applications enabled by these data sets include: compliance with drug regimens and other lifestyle recommendations, drug titration and/or escalation/de-escalation, and diagnosis and/or treatment throughout the progression of the disease.
- Conditions
- Diabetes Mellitus, Type 2, Pre-diabetes
- Being tested
- G6
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G6Device
Wear 9 wear periods of the 10-day CGM
| Study group | Role | What they receive |
|---|---|---|
| Prediabetes (both IGT and IFG) | Device: G6 Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| Type 2 Diabetes on 1 OAD | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| Type 2 Diabetes on 2 or more OAD | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| Type 2 Diabetes using Basal insulin with or without OAD | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| Type 2 Diabetes in GLP-1 with or without OAD | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| Type 2 Diabetes using intense insulin treatment-Multiple Dail | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| Type 2 Diabetes in MDI or basal insulin plus GLP-1 | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| Type 2 Diabetes on 0 OAD | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 | |
| High Risk to Develop Prediabetes / Type 2 Diabetes | Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily Receives: Device: G6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect Device Data - CGM
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM approximately 80% of the time for each subject that completes the entire active phase.
Measured: up to 16 weeks
Collect Device Data - e-Diary
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging diabetic medication taken or not taken 80% of the time for each subject that completes the entire active phase.
Measured: up to 16 weeks
Collect Device Data - e-Diary
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging food intake approximately 80% of the time for each subject that completes the entire active phase.
Measured: up to 16 weeks
Collect Device Data - Activity Tracker
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging lifestyle by activity tracker approximately 80% of the time for each subject that completes the entire active phase.
Measured: up to 16 weeks
Secondary outcomes (1)
Collect Current Subject Lifestyle and Treatment Regimen
Collect subjects current treatment already established for Prediabetes and Type 2 Diabetes
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start22 Jul 2020
- Primary completion27 Feb 2022 (estimated)
- Study completion27 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danny Chernavvsky, MD, Study director, DexCom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503239
- Sponsor's protocol ID
- PTL-904050
- Acronym
- T2Help
- Status last verified
- Oct 2021
- First submitted
- 4 Aug 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediabetes and Type 2 Diabetes Data Collection Study: T2Help
- ClinicalTrials.gov ID
- NCT04503239
- Acronym / sponsor ID
- T2Help / PTL-904050
- Conditions
- Diabetes Mellitus, Type 2, Pre-diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 27 Feb 2022 (estimated)
- Study completion
- 27 Feb 2022 (estimated)
- First posted
- 7 Aug 2020 (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 collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM, medication and food intake approximately 80% of the time for each subject that completes the entire active phase.
Detailed description
In addition, lifestyle and treatment already established for prediabetes and Type 2 Diabetes such as:
- Sleep
- Exercise/Physical activity/or lack of it
- Heart rate
- Five hours OGTT- 6 subjects in each group that have C-Peptide positive lab result at screening and consent to the OGTT (Appendix 3) This data will address the sources and nature of blood glucose variability across the progression of PD and T2D. The data collected in this study will enable investigation into CGM-data artifacts that speak to the state and management of PD and T2D. Possible applications enabled by these data sets include: compliance with drug regimens and other lifestyle recommendations, drug titration and/or escalation/de-escalation, and diagnosis and/or treatment throughout the progression of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Prediabetes (both IGT and IFG) | – | Device: G6Device: G6 Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| Type 2 Diabetes on 1 OAD | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| Type 2 Diabetes on 2 or more OAD | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| Type 2 Diabetes using Basal insulin with or without OAD | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| Type 2 Diabetes in GLP-1 with or without OAD | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| Type 2 Diabetes using intense insulin treatment-Multiple Dail | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| Type 2 Diabetes in MDI or basal insulin plus GLP-1 | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| Type 2 Diabetes on 0 OAD | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
| High Risk to Develop Prediabetes / Type 2 Diabetes | – | Device: G6Participant to wear G6 and activity tracker for 3 months and add meals and medications into e-diary daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-diabetics and Type 2 Diabetics 18 and over willing to wear 2 study devices and enter in the daily medication and food intake.
Key inclusion criteria (16 listed)
- Subjects ages ≥18 years of age at the time of screening
- High Risk of developing PD or T2D with HbA1c ≤5.6%
- Strong family history of T2D
- BMI ≥35 kg/m2
- History of gestational diabetes mellitus (GDM)
Key exclusion criteria (23 listed)
- Hospital admissions for diabetes ketoacidosis (DKA) or Hyperglycemic Hyperosmolar Nonketotic Syndrome (HHNS) in the last 6 months.
- History of 2 or more episodes of severe hypoglycemia, which resulted in any of the following during the 6 months prior to screening:
- Medical assistance by a third party (Caregiver needed to inject glucagon, ER visit, hospitalization) Coma Seizures
- Subject has a skin condition for which he/she is unable to tolerate tape adhesive in the area of sensor placement.
- Pregnancy (as demonstrated by a positive test at study entry) at time of screening or are planning to become pregnant during the study.
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 |
|---|---|---|
| G6Wear 9 wear periods of the 10-day CGM | Device | High Risk to Develop Prediabetes / Type 2 Diabetes, Prediabetes (both IGT and IFG), Type 2 Diabetes in GLP-1 with or without OAD, Type 2 Diabetes in MDI or basal insulin plus GLP-1, Type 2 Diabetes on 0 OAD, Type 2 Diabetes on 1 OAD, Type 2 Diabetes on 2 or more OAD, Type 2 Diabetes using Basal insulin with or without OAD, Type 2 Diabetes using intense insulin treatment-Multiple Dail |
Primary outcome
Collect Device Data - CGM
Time frame: up to 16 weeks
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including time correlated CGM approximately 80% of the time for each subject that completes the entire active phase.
Collect Device Data - e-Diary
Time frame: up to 16 weeks
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging diabetic medication taken or not taken 80% of the time for each subject that completes the entire active phase.
Collect Device Data - e-Diary
Time frame: up to 16 weeks
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging food intake approximately 80% of the time for each subject that completes the entire active phase.
Collect Device Data - Activity Tracker
Time frame: up to 16 weeks
To collect data in an observational study from Prediabetes (PD) and Type 2 Diabetes (T2D) patients including logging lifestyle by activity tracker approximately 80% of the time for each subject that completes the entire active phase.
1 secondary outcome
Collect Current Subject Lifestyle and Treatment Regimen
Time frame: up to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- 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.
Danny Chernavvsky, MD study director
DexCom, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Pre-diabetes, run by DexCom, Inc. at 5 sites 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 16 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
Collect Device Data - CGM (time frame: up to 16 weeks). 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?
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 5 Oct 2021; AzTrials last refreshed its copy on 28 Oct 2026.