Inpatient Diabetes on Corticosteroids
9 сентября 2019 г. обновлено: Hennepin Healthcare Research Institute
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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
As above.
Тип исследования
Интервенционный
Регистрация (Действительный)
85
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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-
Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55415
- Hennepin County Medical Center
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 79 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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 |
NPH given per study table based on steroid dose and patient weight in kg.
Другие имена:
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.
Другие имена:
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Активный компаратор: Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
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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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Mean POC Glucose Level Between Groups
Временное ограничение: Assessed from enrollment to discharge or enrollment to day five.
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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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Episodes of Hypoglycemia Between NPH and Control Groups
Временное ограничение: 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.
|
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.
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
Временное ограничение: 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.
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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.
|
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Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
Временное ограничение: 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.
|
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.
|
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Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
Временное ограничение: 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.
|
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.
|
|
Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
Временное ограничение: 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.
|
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.
|
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Difference in Length of Stay Between NPH and Control Group
Временное ограничение: Measured from the day of admission till the day of discharge
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Time difference of hospitalization between the NPH and control groups.
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Measured from the day of admission till the day of discharge
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Mean Point of Care (POC) Glucose Level in Both Groups.
Временное ограничение: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
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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.
|
|
Mean Point of Care (POC) Glucose Level in Both Groups.
Временное ограничение: 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.
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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.
|
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Correlation of C-peptide With Age
Временное ограничение: plasma C-peptide was measured once at the time of enrollment
|
plasma C-peptide was measured once at the time of enrollment
|
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Correlation of C-peptide With BMI
Временное ограничение: Measured once at the time of enrollment
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Measured once at the time of enrollment
|
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Correlation of C-peptide With eGFR
Временное ограничение: Measured once at the time of enrollment
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Measured once at the time of enrollment
|
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Correlation of C-peptide With Serum Creatinine
Временное ограничение: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
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Correlation of C-peptide With ALT
Временное ограничение: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
|
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Correlation of C-peptide With Hemoglobin A1c
Временное ограничение: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
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Correlation of C-peptide With Duration of Diabetes
Временное ограничение: Measured once at the time of enrollment
|
Measured once at the time of enrollment
|
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Correlation of C-peptide With Plasma Glucose
Временное ограничение: Measured the time of enrollment
|
Measured the time of enrollment
|
|
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Correlation of C-peptide With Length of Stay
Временное ограничение: Measured once at the time of enrollment
|
Measured once at the time of enrollment
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Lisa Fish, MD, Hennepin County Medical Center, Minneapolis
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июля 2014 г.
Первичное завершение (Действительный)
1 июня 2016 г.
Завершение исследования (Действительный)
1 июня 2016 г.
Даты регистрации исследования
Первый отправленный
4 сентября 2013 г.
Впервые представлено, что соответствует критериям контроля качества
24 октября 2013 г.
Первый опубликованный (Оценивать)
28 октября 2013 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 октября 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 сентября 2019 г.
Последняя проверка
1 сентября 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MMRF-13-3658
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .