N/A
N=80
Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease
Diabetes · Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03383627 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Mean Glucose Concentration Measured by CGM — 151.5 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Glucose Monitoring (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Glucose Concentration Measured by CGM |
151.5 | — |
| PRIMARY Number of Participants With Hypoglycemic Events |
61 | — |
| PRIMARY Mean Number of Hypoglycemic Events Per Participant. |
7.5 | — |
| PRIMARY Duration Hypoglycemic Events |
7.5 | — |
| PRIMARY Mean HbA1c |
7.2 | — |
| SECONDARY Mean Serum Fructosamine Concentration |
304.1 | — |
| SECONDARY Determination of Serum Fructosamine |
304.1 | — |
Summary
Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. There are reasons to believe that the tests may be less accurate in this population. Continuous glucose monitoring (CGM) offers an effective method for understanding the totality of glucose exposure and incidence of both hyperglycemic and hypoglycemic excursions.
Eligibility Criteria
Inclusion Criteria
- 18 years and older with ability to speak and understand English
- Established diagnosis of type 2 Diabetes Mellitus
- Chronic Kidney Disease (stages 3b, 4 or 5, eGFR (Glomerular Filtration Rate) < 45 ml/min, and not on dialysis) documented within 3 months of enrollment
Exclusion Criteria
- Type 2 Diabetes Mellitus.
- Patient with End stage kidney disease on Dialysis.
- Presence of Hemoglobinopathies.
- Red blood cell transfusion in the last 12 weeks.
- Hb < 9 g/dL documented within 3 months of enrollment - Dosing with an erythropoiesis stimulating agent is acceptable but dose must be stable for two months.
- Use of acetaminophen on a daily basis.
- Systemic steroid treatment in the past 12 weeks.
- Greater than 50% dose change in diabetes medications or new diabetes medications started in the previous 8 weeks.
- Currently pregnant.
Data sourced from ClinicalTrials.gov (NCT03383627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.