Use of CGM in Kidney Transplant Recipients

NCT04783441 | Recruiting FDA Device

• 1 other identifier: 1554226
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to study the impact CGM (continuous glucose monitoring) has on patients glycemic control as determined by time in range (TIR 70-180 mg/dL) in the Diabetic Kidney Transplant population.

Conditions

Kidney Transplant; Complications; Diabetes Mellitus, Type 2; Insulin Dependent Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in Range (70-180 mg/dl)

  1\) Time in Range: Number of minutes per day or percentage of time that glucose levels are in low (BG\<70), target (BG 70-180), high (BG \>180) or very high (BG\>250) ranges.

  70 days

Secondary Outcomes (5)

• Glycemic variability

  70 days

• CGM satisfaction questionnaire (10 questions)

  up to 70 days

• Adherence to Diabetic Diet

  up to 70 days

• Incidence of all-cause emergency room utilization and rehospitalizations

  70 days

• Incidence of post-transplant infections during study period

  70 days

Other Outcomes (1)

• safety endpoint Hypoglycemia

  70 days

Study Arms (2)

Continuous glucose monitoring (CGM)

ACTIVE COMPARATOR

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.

Device: Dexcom G6

Self monitoring of blood glucose (fingersticks)

PLACEBO COMPARATOR

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.

Device: Dexcom G6 blinded sensor

Interventions

Dexcom G6 DEVICE

access to continuous glucose monitoring in the Dexcom G6 arm 24/7

Continuous glucose monitoring (CGM)

Dexcom G6 blinded sensor DEVICE

retrospective access to continuous glucose profile after 10 days of wear

Self monitoring of blood glucose (fingersticks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above
• Received a kidney transplant within the past year with functioning kidney (eGFR \> 30 mL/min
• Person with Type 2 Diabetes and on insulin
• Access to home wi-fi connection

You may not qualify if:

• Person with Type 1 Diabetes
• Patients taking hydroxyurea
• Patient unable to wear the Dexcom G6 device at all times for any reason
• Must be able to test blood glucose with meter 4x a day when on blinded CGM.
• Presence of clinically significant visual or cognitive impairment
• Illiterate
• Prisoners
• Women who are pregnant, who plan to become pregnant during the course of the study, or who are breastfeeding
• Presence of clinically unstable cardiovascular disease
• Active malignancy treatment

Sponsors & Collaborators

• University of California, Davis: lead
• DexCom, Inc.: collaborator

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

RECRUITING

Related Publications (10)

• Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.

  PMID: 28828487 BACKGROUND

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 BACKGROUND

• Olafsdottir AF, Polonsky W, Bolinder J, Hirsch IB, Dahlqvist S, Wedel H, Nystrom T, Wijkman M, Schwarcz E, Hellman J, Heise T, Lind M. A Randomized Clinical Trial of the Effect of Continuous Glucose Monitoring on Nocturnal Hypoglycemia, Daytime Hypoglycemia, Glycemic Variability, and Hypoglycemia Confidence in Persons with Type 1 Diabetes Treated with Multiple Daily Insulin Injections (GOLD-3). Diabetes Technol Ther. 2018 Apr;20(4):274-284. doi: 10.1089/dia.2017.0363. Epub 2018 Apr 2.

  PMID: 29608107 BACKGROUND

• Edelman SV, Argento NB, Pettus J, Hirsch IB. Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring. Diabetes Care. 2018 Nov;41(11):2265-2274. doi: 10.2337/dc18-1150.

  PMID: 30348844 BACKGROUND

• Saisho Y. Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes. Int J Environ Res Public Health. 2018 May 9;15(5):947. doi: 10.3390/ijerph15050947.

  PMID: 29747423 BACKGROUND

• Garber AJ, Handelsman Y, Grunberger G, Einhorn D, Abrahamson MJ, Barzilay JI, Blonde L, Bush MA, DeFronzo RA, Garber JR, Garvey WT, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Perreault L, Rosenblit PD, Samson S, Umpierrez GE. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2020 EXECUTIVE SUMMARY. Endocr Pract. 2020 Jan;26(1):107-139. doi: 10.4158/CS-2019-0472. No abstract available.

  PMID: 32022600 BACKGROUND

• American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S98-S110. doi: 10.2337/dc20-S009.

  PMID: 31862752 BACKGROUND

• Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.

  PMID: 31177185 BACKGROUND

• Longo R, Sperling S. Personal Versus Professional Continuous Glucose Monitoring: When to Use Which on Whom. Diabetes Spectr. 2019 Aug;32(3):183-193. doi: 10.2337/ds18-0093.

  PMID: 31462872 BACKGROUND

• American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S77-S88. doi: 10.2337/dc20-S007.

  PMID: 31862750 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ling Chen, MD

  UCDavis Transplant Nephrology

  STUDY DIRECTOR

Central Study Contacts

Dahlia Zuidema, PharmD

CONTACT

916-734-4009; dmzuidema@ucdavis.edu

Clinical Research Coordinators

CONTACT

916-734-4009; HS-TransplantCenterResearch@ucdavis.edu

Study Design

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

Model Details: We propose a single-center, prospective, randomized study comprising 2 study arms. They will be randomized in a stratified fashion. Stratification will be according to whether or not they are on prednisone and their estimated glomerular filtration rate. This is to ensure that both arms are populated by equal numbers of patients with prednisone and with worse renal function

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 5, 2021
• Study Start: June 29, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)