Use of CGM in Kidney Transplant Recipients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Continuous Glucose Monitoring (CGM) to Improve Glycemic Control in Kidney Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783441
• Other study ID #: 1554226
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of California, Davis
• Contact: Dahlia Zuidema, PharmD
• Phone: 916-734-4009
• Email: dmzuidema[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Diabetes is one of the leading causes of End Stage Renal Disease (ESRD). Kidney transplantation is the best form of renal replacement therapy to date but requires that recipients of transplant organs maintain a complicated medication regimen in order to prevent graft loss. Their medications include lifelong immunosuppression, anti-microbials and other maintenance medications (i.e., anti-hypertensives, heart-protective regimens, bowel care, vitamins and pain medications). For many transplant patients, glycemic control in the immediate post-operative period can be an additional challenge. Glycemic control may be hindered by recent surgery, corticosteroids, immunosuppressants, altered nutritional intake and reduced mobility. Diabetes professional organizations such as the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) recommend continuous glucose monitoring (CGM) for anyone on intensive insulin therapy. The biggest benefit of CGM is not just the actual glucose value, but also its direction and rate of change. CGM data can also be downloaded and reflect patterns of glycemic control throughout the day and night, including not only the average blood glucose but also time-in-range (TIR) and degrees of glycemic variability. This can help identify unnotified nightly hypoglycemia or hyperglycemia and help titrate medications to achieve better glycemic control. Self-Management of blood glucose (SMBG) is a key component in effective glycemic management, but it places a large burden on the patient. Prior to CGM, SMBG was the only option to measure daily blood glucose fluctuations, but it is an imperfect tool. For patients on insulin, a blood glucose is checked at minimum 4 times per day, prior to meals and at bedtime. Additionally, the utility of SMBG can be endangered by patient decision making, the ability to check blood glucose, adherence to testing regimen, error due to poor testing technique, inadequate blood supply, contamination on fingers, or inaccuracy of some systems. Numerous studies have shown the clinical benefit of CGM in the type-1 diabetes (T1D) and type-2 diabetes (T2D) populations (ref: Beck, Olafsdottir). The DIAMOND group (Beck) showed that CGM improved HBA1C and reduced hyperglycemia (BG>180). Patients wearing the CGM had high satisfaction scores and low perceived burden. CGM is still a new tool outside of the Type 1 Diabetes population but may have significant benefits for any patient on insulin. In Feb 2019 an international guideline on TIR (defined as blood glucose of 70-180 mg/dL) was published and TIR may become a new standard for assessing glycemic control. The investigators research focuses on TIR and the benefits of CGM in the kidney transplant population. This can be essential for timely adjustments of insulin dosages when dealing with glycemic derangements and steroid induced hyperglycemia. CGM can provide an immense opportunity for a continuous 24/7 view of glucose values, glycemic variability, direction of change and unrecognized blood glucose levels during nighttime, and influence of food and activity on blood glucose values. In addition to the metrics described; the glucose management indicator (GMI) or also named estimated A1C (eA1C) is a measure converting the mean glucose from CGM using a formula derived from glucose readings from a population of individuals, into an estimate of a simultaneously measured laboratory A1C, this value may serve as an additional tool in assessing glycemic control. In conclusion: the use of a CGM can aid the provider and care team in better titration of insulin and medication regimen adjustment. This research hopes to give insight in a very complex population that has not had access to CGM before.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or above

2. Received a kidney transplant within the past year with functioning kidney (eGFR > 30 mL/min

3. Person with Type 2 Diabetes and on insulin

4. Access to home wi-fi connection

Exclusion Criteria:

1. Person with Type 1 Diabetes

2. Patients taking hydroxyurea

3. Patient unable to wear the Dexcom G6 device at all times for any reason

4. Must be able to test blood glucose with meter 4x a day when on blinded CGM.

5. Presence of clinically significant visual or cognitive impairment

6. Illiterate

7. Prisoners

8. Women who are pregnant, who plan to become pregnant during the course of the study, or who are breastfeeding

9. Presence of clinically unstable cardiovascular disease

10. Active malignancy treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Insulin Dependent Diabetes
• Kidney Transplant; Complications

Intervention

Device:
• Dexcom G6
access to continuous glucose monitoring in the Dexcom G6 arm 24/7
• Dexcom G6 blinded sensor
retrospective access to continuous glucose profile after 10 days of wear

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Dahlia M Zuidema	DexCom, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Erratum In: Diabetes Care. 2020 Aug;43(8):1981. — View Citation

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. Erratum In: Diabetes Care. 2020 Aug;43(8):1979. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety endpoint Hypoglycemia	Hypoglycemia risk will be assessed as percentage of time below range (BG<70 mg/dl) and very low (BG <54 mg/dl).	70 days
Primary	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	Glycemic variability	assessed by the Coefficient of Variation (Glucose standard deviation divided by mean glucose). % CV is a standardized measure that assesses the magnitude of glucose variability	70 days
Secondary	CGM satisfaction questionnaire (10 questions)	score on CGM questionnaire (1 = lowest and 5 = highest)	up to 70 days
Secondary	Adherence to Diabetic Diet	Use of ASA24 online 24 hr dietary recall at 3 times throughout the study	up to 70 days
Secondary	Incidence of all-cause emergency room utilization and rehospitalizations	during the study period (70 days)	70 days
Secondary	Incidence of post-transplant infections during study period	during the study period (70 days)	70 days