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Continuous Glucose Monitoring

CGM for Diabetes after Kidney Transplant

N/A

Recruiting

Research Sponsored by Dahlia M Zuidema

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or above

Person with Type 2 Diabetes and on insulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 70 days

Awards & highlights

Study Summary

This trial will study how well a continuous glucose monitor works in people who have diabetes and have had a kidney transplant.

Who is the study for?

This trial is for adults over 18 with Type 2 Diabetes who use insulin and have had a kidney transplant within the last year. Participants need functioning kidneys, access to home Wi-Fi, and must be able to test their blood sugar four times daily if using the blinded CGM. It's not for those with Type 1 Diabetes, unstable heart disease, active cancer treatment, significant visual or cognitive issues, or women who are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study examines how continuous glucose monitoring (CGM) affects blood sugar control in diabetic kidney transplant patients. The Dexcom G6 device will be used to monitor glucose levels continuously to see if it helps maintain them within a target range.See study design

What are the potential side effects?

While the Dexcom G6 generally has minimal side effects as it's non-invasive, potential issues may include skin irritation at the sensor site or allergic reactions. Incorrect readings can occur but are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have Type 2 Diabetes and am taking insulin.

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I had a kidney transplant within the last year and my kidney is working well.

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I had a kidney transplant within the last year and my kidney works well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 70 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~70 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 70 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time in Range (70-180 mg/dl)

Secondary outcome measures

Adherence to Diabetic Diet

CGM satisfaction questionnaire (10 questions)

Glycemic variability

+2 more

Other outcome measures

safety endpoint Hypoglycemia

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Continuous glucose monitoring (CGM)Active Control1 Intervention

Those in the intervention arm will wear a continuous glucose monitoring device. They only need to perform blood glucose fingersticks if the CGM transmission is lost for a prolonged period of time or in cases of hypo- or hyperglycemia when symptoms don't align with blood glucose readings.

Group II: Self monitoring of blood glucose (fingersticks)Placebo Group1 Intervention

The control arm will remain on standard-of-care SMBG while the intervention arm will use their CGM. The control arm utilizing SMBG will be required to have at minimum 4 glucose checks per day.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Dahlia M ZuidemaLead Sponsor

DexCom, Inc.Industry Sponsor

137 Previous Clinical Trials

29,765 Total Patients Enrolled

Ling Chen, MDStudy DirectorUCDavis Transplant Nephrology

Media Library

Dexcom G6 (Continuous Glucose Monitoring) Clinical Trial Eligibility Overview. Trial Name: NCT04783441 — N/A

Type 2 Diabetes Research Study Groups: Continuous glucose monitoring (CGM), Self monitoring of blood glucose (fingersticks)

Type 2 Diabetes Clinical Trial 2023: Dexcom G6 Highlights & Side Effects. Trial Name: NCT04783441 — N/A

Dexcom G6 (Continuous Glucose Monitoring) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04783441 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for individuals to enroll in this research?

"Per the information found on clinicaltrials.gov, this research program is presently seeking participants with its first post date being June 29th 2021 and last edit made August 4th 2022."

Answered by AI

What is the current cohort size for this research?

"Indeed, the clinicaltrials.gov website contains information suggesting that this medical experiment is presently taking on volunteers. It initially went up for recruitment on June 29th 2021 and was most recently updated August 4th 2022. This trial requires 80 individuals at a single research centre to participate."

Answered by AI