Diabetes Mellitus
Conditions
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.
Interventions
DEVICEContinuous 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_TESTFinger Stick Glucose Measurement
Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.
DRUGInsulin
Insulin will be administered.
DEVICEContinuous 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.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Glucose | Postoperative day 1 - 5 | The primary outcome of this study is average daily glucose level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hyperglycemic Episodes | Postoperative days 1-5 | The number of episodes where glucose goes from \<180mg/dl to ≥ 180 mg/dl. |
| Number of Hypoglycemic Episodes | Postoperative days 1-5 | The number of episodes where glucose levels go from \> 80 mg/dl to ≤ 80 mg/dl |
| Total Insulin Use | Postoperative days 1-5 | The total number of insulin units used |
Countries
United States
Outcome results
None listed