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

Early Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Diagnostic Test: Finger Stick Glucose Measurement; Device: Continuous Glucose Monitor Application; Device: Continuous Glucose Monitor Placebo Applied; Drug: Insulin

• Registration Number: NCT04742023
• Lead Sponsor: Northwell Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-21
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-05
• Primary Completion: 2023-11-21
• Status Verified: 2023-12
• Study Completion: 2023-12-21
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Arm	Continuous Glucose Monitor Placebo Applied	-
Control Arm	Finger Stick Glucose Measurement	-
Intervention Arm	Continuous Glucose Monitor Application	-
Intervention Arm	Finger Stick Glucose Measurement	-
Intervention Arm	Insulin	-
Control Arm	Insulin	-

Primary Outcome Measures

Name	Time	Method
Average Daily Glucose	Postoperative day 1 - 5	The primary outcome of this study is average daily glucose level.

Secondary Outcome Measures

Name	Time	Method
Number of Hyperglycemic Episodes	Postoperative days 1-5	The number of episodes where glucose goes from \<180mg/dl to ≥ 180 mg/dl.
Total Insulin Use	Postoperative days 1-5	The total number of insulin units used
Number of Hypoglycemic Episodes	Postoperative days 1-5	The number of episodes where glucose levels go from \> 80 mg/dl to ≤ 80 mg/dl

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States