Clinical trial NCT01970241: Inpatient Diabetes on Corticosteroids
Official title: Inpatient Diabetes on Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: corticosteroid
diabetes
insulin
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2013-10-28
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

Detailed description: As above.

Eligibility criteria: Inclusion Criteria:

* Prior history of diabetes
* Able to provide informed consent
* Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
* Expect to be hospitalized for 48 hours

Exclusion Criteria:

* Renal failure with GFR (glomerular filtration rate) \< 30 ml/min/1.73m2
* ALT (alanine aminotransferase) \> 2 times upper normal for laboratory

Primary outcomes:
measure: Mean POC Glucose Level Between Groups
timeFrame: Assessed from enrollment to discharge or enrollment to day five.
Secondary outcomes:
measure: Episodes of Hypoglycemia Between NPH and Control Groups
timeFrame: Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
Other outcomes:
measure: Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
timeFrame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
measure: Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
timeFrame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
measure: Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
timeFrame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
measure: Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
timeFrame: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
measure: Difference in Length of Stay Between NPH and Control Group
timeFrame: Measured from the day of admission till the day of discharge
measure: Mean Point of Care (POC) Glucose Level in Both Groups.
timeFrame: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
measure: Mean Point of Care (POC) Glucose Level in Both Groups.
timeFrame: On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
measure: Correlation of C-peptide With Age
timeFrame: plasma C-peptide was measured once at the time of enrollment
measure: Correlation of C-peptide With BMI
timeFrame: Measured once at the time of enrollment
measure: Correlation of C-peptide With eGFR
timeFrame: Measured once at the time of enrollment
measure: Correlation of C-peptide With Serum Creatinine
timeFrame: Measured once at the time of enrollment
measure: Correlation of C-peptide With ALT
timeFrame: Measured once at the time of enrollment
measure: Correlation of C-peptide With Hemoglobin A1c
timeFrame: Measured once at the time of enrollment
measure: Correlation of C-peptide With Duration of Diabetes
timeFrame: Measured once at the time of enrollment
measure: Correlation of C-peptide With Plasma Glucose
timeFrame: Measured the time of enrollment
measure: Correlation of C-peptide With Length of Stay
timeFrame: Measured once at the time of enrollment
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: Lisa Fish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khowaja A, Alkhaddo JB, Rana Z, Fish L. Glycemic Control in Hospitalized Patients with Diabetes Receiving Corticosteroids Using a Neutral Protamine Hagedorn Insulin Protocol: A Randomized Clinical Trial. Diabetes Ther. 2018 Aug;9(4):1647-1655. doi: 10.1007/s13300-018-0468-3. Epub 2018 Jun 30.