Inpatient Diabetes on Corticosteroids

Diabetes Mellitus Clinical Trial

Official title:

Inpatient Diabetes on Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970241
• Other study ID #: MMRF-13-3658
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2019
• Source: Hennepin Healthcare Research Institute.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• NPH
NPH given per study table based on steroid dose and patient weight in kg.
• Correction Factor
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute.	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL	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 are the overall percentage of glucose measurements between 70 - 180 mg/dl.	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.
Other	Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL	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 are the overall percentage of glucose measurements 180 - 300 mg/dL.	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.
Other	Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl	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 are the overall percentage of glucose measurements 300 - 400 mg/dl.	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.
Other	Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL	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 are the overall percentage of glucose measurements > 400 mg/dL.	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.
Other	Difference in Length of Stay Between NPH and Control Group	Time difference of hospitalization between the NPH and control groups.	Measured from the day of admission till the day of discharge
Other	Mean Point of Care (POC) Glucose Level in Both Groups.	The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.	On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
Other	Mean Point of Care (POC) Glucose Level in Both Groups.	The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.	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.
Other	Correlation of C-peptide With Age		plasma C-peptide was measured once at the time of enrollment
Other	Correlation of C-peptide With BMI		Measured once at the time of enrollment
Other	Correlation of C-peptide With eGFR		Measured once at the time of enrollment
Other	Correlation of C-peptide With Serum Creatinine		Measured once at the time of enrollment
Other	Correlation of C-peptide With ALT		Measured once at the time of enrollment
Other	Correlation of C-peptide With Hemoglobin A1c		Measured once at the time of enrollment
Other	Correlation of C-peptide With Duration of Diabetes		Measured once at the time of enrollment
Other	Correlation of C-peptide With Plasma Glucose		Measured the time of enrollment
Other	Correlation of C-peptide With Length of Stay		Measured once at the time of enrollment
Primary	Mean POC Glucose Level Between Groups	Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.	Assessed from enrollment to discharge or enrollment to day five.
Secondary	Episodes of Hypoglycemia Between NPH and Control Groups	Hypoglycemia was defined as point of care glucose less than 70 mg/dL.	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.