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NCT01970241 · ClinicalTrials.gov registry record · Phase 4
Inpatient Diabetes on Corticosteroids
A Phase 4 study, sponsored by Hennepin Healthcare Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 85
- Enrollment target
NCT01970241: Completed Phase 4 study, sponsored by Hennepin Healthcare Research Institute.
NCT01970241 is a Phase 4 study that has completed, run by Hennepin Healthcare Research Institute. The registered enrollment target is 85 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970241, a Phase 4 study, has completed, sponsored by Hennepin Healthcare Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 85 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG NPH
- DRUG Correction Factor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
What the finished NCT01970241 record still lists
NCT01970241 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which NPH is the first listed.
NCT01970241 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01970241 about?
NCT01970241 is a clinical study titled "Inpatient Diabetes on Corticosteroids". 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 sc...
What is the current status of trial NCT01970241?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 85 participants. The study started on 2014-07. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01970241?
The interventions under investigation include: NPH (DRUG), Correction Factor (DRUG).
Who is sponsoring clinical trial NCT01970241?
This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01970241's enrollment target sits among peer trials
85 928th of 2000 higher than 1,072 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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