Inpatient Diabetes on Corticosteroids

• ClinicalTrials.gov Identifier: NCT01970241
• Recruitment Status: Completed
• First Posted: October 28, 2013
• Results First Posted: October 1, 2019
• Last Update Posted: October 1, 2019
• Sponsor: Hennepin Healthcare Research Institute
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): Hennepin Healthcare Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus	Drug: NPH; Drug: Correction Factor	Phase 4

Detailed Description:

As above.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 85 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Inpatient Diabetes on Corticosteroids
• Study Start Date: July 2014
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: NPH with steroid dose; Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg	Drug: NPH; NPH given per study table based on steroid dose and patient weight in kg.; Other Name: NPH Lilly Insulin; Drug: 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.; Other Name: Rapid acting regular insulin
Active Comparator: Control - Background and correction insulin; Receive usual care with background insulin and correction factor for duration of study (2-5 days)	Drug: 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.; Other Name: Rapid acting regular insulin

Outcome Measures

Primary Outcome Measures :

1. Mean POC Glucose Level Between Groups [ Time Frame: Assessed from enrollment to discharge or enrollment to day five. ]
   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.

Secondary Outcome Measures :

1. Episodes of Hypoglycemia Between NPH and Control Groups [ Time Frame: 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. ]
   Hypoglycemia was defined as point of care glucose less than 70 mg/dL.

Other Outcome Measures:

1. Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL [ Time Frame: 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. ]
   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.
2. Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL [ Time Frame: 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. ]
   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.
3. Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl [ Time Frame: 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. ]
   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.
4. Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL [ Time Frame: 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. ]
   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.
5. Difference in Length of Stay Between NPH and Control Group [ Time Frame: Measured from the day of admission till the day of discharge ]
   Time difference of hospitalization between the NPH and control groups.
6. Mean Point of Care (POC) Glucose Level in Both Groups. [ Time Frame: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time. ]
   The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.
7. Mean Point of Care (POC) Glucose Level in Both Groups. [ Time Frame: 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. ]
   The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.
8. Correlation of C-peptide With Age [ Time Frame: plasma C-peptide was measured once at the time of enrollment ]
9. Correlation of C-peptide With BMI [ Time Frame: Measured once at the time of enrollment ]
10. Correlation of C-peptide With eGFR [ Time Frame: Measured once at the time of enrollment ]
11. Correlation of C-peptide With Serum Creatinine [ Time Frame: Measured once at the time of enrollment ]
12. Correlation of C-peptide With ALT [ Time Frame: Measured once at the time of enrollment ]
13. Correlation of C-peptide With Hemoglobin A1c [ Time Frame: Measured once at the time of enrollment ]
14. Correlation of C-peptide With Duration of Diabetes [ Time Frame: Measured once at the time of enrollment ]
15. Correlation of C-peptide With Plasma Glucose [ Time Frame: Measured the time of enrollment ]
16. Correlation of C-peptide With Length of Stay [ Time Frame: Measured once at the time of enrollment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55415

Sponsors and Collaborators

Hennepin Healthcare Research Institute

Eli Lilly and Company

Investigators

• Principal Investigator: Lisa Fish, MD; Hennepin County Medical Center, Minneapolis

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT01970241
• Other Study ID Numbers: MMRF-13-3658
• First Posted: October 28, 2013
• Results First Posted: October 1, 2019
• Last Update Posted: October 1, 2019
• Last Verified: September 2019

Keywords provided by Hennepin Healthcare Research Institute:

corticosteroid; diabetes; insulin

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Insulin, Globin Zinc; Hypoglycemic Agents; Physiological Effects of Drugs