- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04585139
Assessing Non-adjunctive CGM Safety at Home and in New Markets (ANSHIN)
July 28, 2022 updated by: DexCom, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Henderson, Nevada, United States, 89074
- Las Vegas Endocrinology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- Planned or currently using weight reduction medications, programs or surgery. Defined as 1) using weight loss medications and losing weight (e.g. chronic use of weight loss medications with stable weight is not exclusionary) or planning on using weight loss prescription medication during the study; 2) currently using or planning on initiating a modified fasting program (e.g. protein-sparing diet plans) during the study; or 3) bariatric surgical procedure within the past year or plans for undergoing bariatric surgery during the study.
- 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,
- Current treatment with hydroxyurea
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Phase 1 -- Introduction to Dexcom G6 CGM
A 2 week run-in wear period of blinded CGM followed by 12 weeks of wear of a Commercially available CGM
|
Examine whether non-adjunctive use of CGM improves glycemic control in adults with diabetes managed by intensive insulin therapy
|
Active Comparator: Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM
1 group will wear a Commercially available CGM for 12 weeks while the 2 group will wear an Updated CGM for 12 weeks.
|
Examine whether non-adjunctive use of CGM improves glycemic control in adults with diabetes managed by intensive insulin therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 16 weeks
|
Phase 1 change in HbA1c for the adult cohort only.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2020
Primary Completion (Actual)
February 7, 2022
Study Completion (Actual)
February 7, 2022
Study Registration Dates
First Submitted
October 5, 2020
First Submitted That Met QC Criteria
October 12, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PTL-903833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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