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Inpatient Diabetes on Corticosteroids

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Hennepin Healthcare

Status and phase

Completed
Phase 4

Conditions

Diabetes Mellitus

Treatments

Drug: Correction Factor
Drug: NPH

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01970241
MMRF-13-3658

Details and patient eligibility

About

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.

Full description

As above.

Enrollment

85 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

85 participants in 2 patient groups

NPH with steroid dose
Experimental group
Description:
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
Treatment:
Drug: Correction Factor
Drug: NPH
Control - Background and correction insulin
Active Comparator group
Description:
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
Treatment:
Drug: Correction Factor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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