RECRUITING

Oral Anti Diabetic Agents in the Hospital

Conditions

Diabetes Mellitus Hyperglycemia Insulin therapy Oral therapy Basal bolus therapy Mean daily blood glucose Hospitalization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This randomized controlled clinical trial will assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in the hospital. The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose concentration between oral antidiabetic medications and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).

Official Title

Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes

Quick Facts

Study Start:2020-08-07

Study Completion:2024-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04416269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Males or females, age 18-80 years admitted to a general medicine and surgery services * Known history of T2D receiving OADs either as monotherapy or in combination therapy * Admission BG \< 250 mg/dl or randomization BG \<250 mg/dl and not receiving basal insulin * Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have HbA1c \<7.5% within the past three months * HbA1c \<10%	* No known history of diabetes * Laboratory evidence of diabetic ketoacidosis * Subjects with a history of type 1 diabetes (suggested by BMI \< 25 requiring insulin therapy or with a history of diabetic ketoacidosis, or ketonuria) * Meeting any exclusion criteria based on specific contraindications to their home oral therapy * Acute critical illness or cardiac surgery expected to require admission to a critical care unit * Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal suction * Medical or surgical patients expected to be kept NPO for \>24-48 hours after admission or after completion of surgical procedure * Impaired renal function (eGFR \<30 ml/min) * Current treatment with oral or injectable corticosteroid * Mental condition rendering the subject unable to understand the nature and scope of the study * Female subjects who are pregnant or breastfeeding at time of enrollment in the study * New or recent onset (within two weeks) of coronavirus disease 2019 (COVID-19) infection at the time of admission

Inclusion Criteria

Exclusion Criteria

* Males or females, age 18-80 years admitted to a general medicine and surgery services
* Known history of T2D receiving OADs either as monotherapy or in combination therapy
* Admission BG \< 250 mg/dl or randomization BG \<250 mg/dl and not receiving basal insulin
* Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have HbA1c \<7.5% within the past three months
* HbA1c \<10%

* No known history of diabetes
* Laboratory evidence of diabetic ketoacidosis
* Subjects with a history of type 1 diabetes (suggested by BMI \< 25 requiring insulin therapy or with a history of diabetic ketoacidosis, or ketonuria)
* Meeting any exclusion criteria based on specific contraindications to their home oral therapy
* Acute critical illness or cardiac surgery expected to require admission to a critical care unit
* Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal suction
* Medical or surgical patients expected to be kept NPO for \>24-48 hours after admission or after completion of surgical procedure
* Impaired renal function (eGFR \<30 ml/min)
* Current treatment with oral or injectable corticosteroid
* Mental condition rendering the subject unable to understand the nature and scope of the study
* Female subjects who are pregnant or breastfeeding at time of enrollment in the study
* New or recent onset (within two weeks) of coronavirus disease 2019 (COVID-19) infection at the time of admission

Contacts and Locations

Study Contact

Maya Fayfman, MD

CONTACT

404-778-1664

maya.fayfman@emory.edu

Principal Investigator

Maya Fayfman, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital Midtown

Atlanta, Georgia, 30322

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

Grady Memorial Hospital

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Maya Fayfman, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-07

Study Completion Date2024-12-01

Study Record Updates

Study Start Date2020-08-07

Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

Hyperglycemia
Insulin therapy
Oral therapy
Basal bolus therapy
Mean daily blood glucose
Hospitalization

Additional Relevant MeSH Terms

Diabetes Mellitus