Clinical Trials

Inclusion Criteria:

• Ages ≥ 8 years (“age” determined at the time of the Insertion Visit)
• A1C between 5.7% and 7.0% and a current diagnosis of prediabetes or Type diabetes on no diabetes medications OR an A1C between 5.7% and 10.0% and a current diagnosis of type diabetes while taking 1 or 2 non-insulin anti-diabetes oral medications, (excluding GLP-1s). All medications should be stable for at least 1 month.
• Willing to wear the required number of up to two (2) Systems (1 CGM and 1 CLM) for the total duration of study wear [up to 60 days of total wear + 48 hours for scheduling purposes];
  1. Insertion location(s) will be the back of the upper arms (i.e., one device on the back of the upper left arm, one device on the back of the upper right arm);
• Participant is able to speak, read, and write in English;
• Willing to participate in Clinic Session with the following parameters during study wear:
  1. One MMTT Clinic Session will take approximately twelve (12) hours. Clinic Session procedures will include: a Mixed Meal Tolerance Test (MMTT) IV venous infusions of stable and radioactive isotope tracers, and frequent venous sampling will be performed. Participants will be randomized into one of three groups:
     • • MMTT/No Activity;
       • MMTT/Moderate Activity;
       • MMTT/Intense Activity (only participants from the no medication group will be randomized to the IA group)
  2. In preparation for the MMTT session, participant is willing to not engage in any physical activity more intense than light walking during days 2, 3, and 4 of Phase 1
  3. In preparation for the MMTT session, participant is willing to abstain from caffeine and alcohol on day 4 of Phase 1
  4. In preparation for the MMTT session, participant is willing to complete an overnight stay on Day 4.
  5. Eight (8) Exercise clinic sessions during the first 30 days of the study (see the study calendar). Clinic Session procedures may include: a structured meal and a 30-minute exercise session.
• Possess a smartphone capable of running the commercially available US G7 mobile application (Android or iOS) and all study applications, to be used for the duration of the study, or be willing to use a study provided, commercially available smartphone if personal smartphone is not compatible with required smartphone applications.
• Absence of any known lung function impairment.
• Injury free as determined by a health history questionnaire and physical examination. 
• Ability to safely engage in a laboratory-run assessment of maximum VO2 consumption. 
• No contraindications per the 2023 PAR-Q+ physical activity readiness questionnaire. 
• Willingness to use study-provided devices: CLM, CGM, Fitbit activity tracker, BLE body weight scale, and Polar H10 chest strap. 
• Chest (below pectoral muscles and above stomach) circumference of 23-55 inches. 
• Access to—and knowledge of use for—a microwave oven, to be used in preparation of structured meals.
• Be willing to participate in a Zoom interview within 4 weeks of study completion.

Exclusion Criteria:

• Participants will be excluded if they meet any of the following criteria:

• Taking (or planning to take) exogenous insulin. 
• History of severe hypoglycemia [complicated by seizure(s) and/or loss of consciousness] within the past 3 months. 
• Taking medication that could affect maximal heart rate or blood pressure (for example: beta-blockers, calcium-channel blockers, digoxin, and anti-arrhythmic medications). 
• History of stroke, heart failure, myocardial infarction, unstable angina, and second- or third-degree heart block. 
• Any contraindications for moderate or intense physical activity properly documented by the PI. 
• For female participants of child-bearing potential: Pregnancy, demonstrated by a positive test no more than 72 hours prior to the Insertion Visit, and not willing to use an acceptable form of contraception during study wear.
• Significant renal dysfunction (eGFR < 45) or hepatic failure defined by elevated liver enzymes (AST above 36 U/L, ALT above 56 U/L). Participants with end stage kidney disease (ESKD) and currently managed by dialysis or anticipating initiating dialysis during the study wear period, will be excluded.
• Allergies to any ingredients in the specified structured meals. 
• Aversions to or dietary restrictions vis-a-vis the specified structured meals that are sufficiently strong to cause non-compliance or inability to fully ingest the prescribe meals. 
• History of bariatric/ weight loss surgery or actively trying to lose weight.
• Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, or dermatitis herpetiformis);
• Known allergy to medical-grade adhesives;
• Known allergy to radioactive or stable isotope tracers;
• A pattern of life in which the subject is not generally asleep during the hours of 12am (midnight) and 5am;
• Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period; However, it’s safe to have a CT scan if you keep the sensor out of the scanned area and cover the sensor with a lead apron during scan;
• Have donated blood, had significant blood loss, or participated in a study with significant blood sampling within 3 months prior to study enrollment or plan to partake in such activities during study wear;
• Current participation in another investigational study protocol (If a participant has recently completed participation in another drug study, the participant must have completed that study at least 30 days prior to being enrolled in this study). Note: Participants will not be excluded if enrolled in another observational trial, wherein the participant is in the follow-up phase and no tests/procedures impacting the participant’s health are required. Participants will be excluded if they have been previously enrolled in this study;
• The participant and/or immediate family member(s), and/or person(s) living within the household work for Dexcom, Medtronic, GlySens Inc., Abbott Laboratories, Roche, Senseonics, Waveform, Ascensia Diabetes Care, or POCTech;
• Current usage of hydroxyurea medication(s);
• Immunocompromised (per Investigator’s discretion) such as known neutropenia, active hematological malignancy, receiving chemotherapy, etc.;
• Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose excessive risk to study staff. Some examples of conditions that Investigators may consider exclusionary are skin or skin allergy condition, HIV, Hepatitis B, or Hepatitis C infections; active illegal substance use; or active psychiatric disorder.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/27/2024. Questions regarding updates should be directed to the study team contact.