Clinical trial NCT04503239: Prediabetes and Type 2 Diabetes Data Collection Study
Official title: Prediabetes and Type 2 Diabetes Data Collection Study: T2Help
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Pre-diabetes
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.)
  * If using additional medication, such as thyroid, hypertension, and cholesterol lowering medication these have to be stable for at least 3 months.

Exclusion Criteria:

* 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.
* 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)

Primary outcomes:
measure: Collect Device Data - CGM
timeFrame: up to 16 weeks
measure: Collect Device Data - e-Diary
timeFrame: up to 16 weeks
measure: Collect Device Data - e-Diary
timeFrame: up to 16 weeks
measure: Collect Device Data - Activity Tracker
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Collect Current Subject Lifestyle and Treatment Regimen
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease
state: Texas
Study officials:
affiliation: DexCom, Inc.
name: Danny Chernavvsky, MD
role: STUDY_DIRECTOR
References: