Prediabetes and Type 2 Diabetes Data Collection Study
T2Help
1 other identifier
observational
306
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 22, 2020
CompletedFirst Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2022
CompletedOctober 5, 2021
October 1, 2021
1.6 years
August 4, 2020
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
up to 16 weeks
Secondary Outcomes (1)
Collect Current Subject Lifestyle and Treatment Regimen
up to 16 weeks
Study Arms (9)
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
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
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
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
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
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
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
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
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
Interventions
Wear 9 wear periods of the 10-day CGM
Eligibility Criteria
Pre-diabetics and Type 2 Diabetics 18 and over willing to wear 2 study devices and enter in the daily medication and food intake.
You may qualify if:
- 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)
- 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.)
- +1 more criteria
You may not qualify if:
- 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.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DexCom, Inc.lead
Study Sites (5)
Synergy San Diego
Lemon Grove, California, 91945, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Diabetes and Glandular Disease
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Danny Chernavvsky, MD
DexCom, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 7, 2020
Study Start
July 22, 2020
Primary Completion
February 27, 2022
Study Completion
February 27, 2022
Last Updated
October 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share