Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation

Diabetes Mellitus Clinical Trial

Official title:

Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742023
• Other study ID #: 20-0066
• Status: Completed
• Phase: Early Phase 1
• Start date: April 21, 2020
• Est. completion date: December 21, 2023

Study information

• Verified date: December 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™ Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18 years or older

4. Undergoing first-time renal transplantation

5. Have a pre-existing diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

1. Age less than 18 years

2. Use of insulin pump at time of transplant

3. Insulin infusion requirement during hospitalization

4. Pregnancy or lactation

5. Known allergic reaction to Guardian™ Sensor 3 or adhesives

6. History of hypoglycemia unawareness

Related Conditions & MeSH terms

• Diabetes Mellitus
• Postoperative Complications

Intervention

Device:
• Continuous Glucose Monitor Application
The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied and values interpreted by nursing.

Diagnostic Test:
• Finger Stick Glucose Measurement
Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.

Drug:
• Insulin
Insulin will be administered.

Device:
• Continuous Glucose Monitor Placebo Applied
The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied however values will not be interpreted.

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Daily Glucose	The primary outcome of this study is average daily glucose level.	Postoperative day 1 - 5
Secondary	Number of Hyperglycemic Episodes	The number of episodes where glucose goes from <180mg/dl to = 180 mg/dl.	Postoperative days 1-5
Secondary	Number of Hypoglycemic Episodes	The number of episodes where glucose levels go from > 80 mg/dl to = 80 mg/dl	Postoperative days 1-5
Secondary	Total Insulin Use	The total number of insulin units used	Postoperative days 1-5