Assessing Non-adjunctive CGM Safety at Home and in New Markets

NCT04585139 | Completed FDA Device

• 1 other identifier: PTL-903833
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Phase 1 change in HbA1c for the adult cohort only.

  16 weeks

Study Arms (2)

Phase 1 -- Introduction to Dexcom G6 CGM

OTHER

A 2 week run-in wear period of blinded CGM followed by 12 weeks of wear of a Commercially available CGM

Device: Phase 1- Introduction to Dexcom G6 CGM

Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM

ACTIVE COMPARATOR

1 group will wear a Commercially available CGM for 12 weeks while the 2 group will wear an Updated CGM for 12 weeks.

Device: Phase 1- Introduction to Dexcom G6 CGM

Interventions

Phase 1- Introduction to Dexcom G6 CGM DEVICE

Examine whether non-adjunctive use of CGM improves glycemic control in adults with diabetes managed by intensive insulin therapy

Phase 1 -- Introduction to Dexcom G6 CGM; Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 2 years or older
• A diagnosis of T1D or T2D made at least 6 months prior to enrollment. At least 20 adult participants will have T1D; and 10 will have T2D; 10 participants will be over age 65 years.
• Using IIT (either an insulin pump or MDI)
• HbA1c value ≥ 7.5% (≥ 58 mmol/mol) measured by local lab within prior 30-days before enrollment or by point of care at time of screening.
• eGFR ≥ 30 within the last 90-days prior to enrollment (adult participants only)
• Currently performing 2 or more SMBG fingersticks a day by historical average and willing to continue this during the blinded CGM wear.

You may not qualify if:

• Use of real-time or intermittently scanned CGM in the 6 months prior to enrollment.
• BMI \> 45.
• Anticipated changes to insulin delivery method or insulin formulation(s).
• Insulin formulation changes within class will be permitted if required per formulary change and represent equivalent therapy (eg: insulin lispro change to insulin aspart).
• Pregnancy (as demonstrated by a positive test at study entry) at time of screening or are planning to become pregnant during the study.
• Applicable only to women of reproductive potential.
• Concomitant disease or condition that may compromise patient safety including, but not limited to; severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long-term medical/psychiatric condition that would interfere with study- related tasks or visits, including ongoing treatment for a significant malignancy. These assessments/conditions are made at investigator's discretion.
• Known (or suspected) significant allergy to medical-grade adhesives.
• Any condition, per investigator assessment, that could impact the stability of the HbA1c measurement, for example,
• Acute or chronic blood loss or bleeding disorder,
• Red blood cell transfusion or erythropoietin, administration in the 3 months prior to enrollment,
• Or red blood cell transfusion or erythropoietin administration anticipated during the course of the study.
• Anticipated acute use of oral or injectable glucocorticoids that could affect glycemic control and impact HbA1c, for example,
• Frequent steroid bursts used for inflammatory arthritis or inflammatory bowel disease,
• Or recurrent lumbar epidural steroid injections,

Sponsors & Collaborators

• DexCom, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (1)

Las Vegas Endocrinology

Henderson, Nevada, 89074, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of two phases. Phase I is a single-arm, prospective, multicenter, interventional design. Phase II is a randomized controlled arm study during which participants will be randomized 1:1 to Commercial CGM or Updated CGM

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: October 6, 2020
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)