Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 Sensor

Dexcom

Status and phase: Active, not recruiting; Phase 1

Conditions: Type 2 Diabetes

Treatments: Device: Dexcom Continuous Glucose Monitoring (CGM); Drug: Basal insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07681375

PTL-1000125

Details and patient eligibility

About

To evaluate the feasibility of the DexBasal Study System

Full description

To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients with a diagnosis of Type 2 diabetes (T2D) mellitus

• Ages equal or greater 18 years ("age" determined at the time of the Screening Visit)
• Bodyweight between 30-450 kg
• Comfortable with and willing to administer basal insulin injections, once a day, for approximately 75 consecutive days, and log daily injections in the Dexcom CGM mobile application.
• Willing to wear Dexcom CGM for duration of study

Exclusion Criteria:

• Recent severe hypoglycemia, complicated by seizure(s) or loss of consciousness, in the past 3 months
• Subjects with any contraindications for starting or continuing basal insulin therapy
• Glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 (within 6 months of insertion) or on hemodialysis
• Introducing or increasing glucose lowering medications simultaneously
• Any condition that, in the opinion of the Investigator, would interfere with a subject's participation in the trial or pose excessive risk to subject and/or study staff
• For subjects of child-bearing potential: Pregnancy, demonstrated by a positive test no more than 72 hours prior to Clinic Visit 1
• Has used prandial insulin in the last 30 days.
• Anticipated addition of medications that could have significant impact on insulin sensitivity such as atypical antipsychotics.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Dexbasal

Other group

Description:

Subjects initiating basal insulin therapy or on basal insulin therapy maintenance and benefit from transitioning to a study-specific type of basal insulin within 72 hours of Phase 1.

Treatment:

Drug: Basal insulin

Device: Dexcom Continuous Glucose Monitoring (CGM)