UMIN-ICDS Clinical Trial

Basic information
Public title	Impact of Pharmacist Outreach on Glucagon Prescribing
Acronym	PhOG
Scientific Title	Impact of Pharmacist Outreach on Glucagon Prescribing
Scientific Title:Acronym	PhOG
Region	North America

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the rate of glucagon prescribing between the pharmacist intervention and the control group in the one month period following pharmacist-led provider outreach.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	to compare the rate of glucagon prescribing between the pharmacist intervention and the control group in the one month period following pharmacist-led provider outreach
Key secondary outcomes	to examine prescribing patterns of glucagon, previous episodes of hypoglycemia, and to identify Type 1 patients with diabetes not under the care of endocrinology

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	patients meeting inclusion criteria and received pharmacist intervention to facilitate glucagon prescribing
Interventions/Control_2	patients meeting inclusion criteria and did not receive pharmacist intervention to facilitate glucagon prescribing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	150 years-old >=
Gender	Male and Female
Key inclusion criteria	A report was generated of patients eligible for Duke PHMO services who were prescribed a rapid acting insulin with glucagon prescribing status as potential subjects for this study. Patients were included in the study if they were prescribed regular or rapid acting insulin, if they were greater than or equal to 18 years of age, and if they had an upcoming primary care provider or endocrinology visit between October 1st, 2020 and January 31st, 2021.
Key exclusion criteria	Patients were excluded from the study if they were deceased, under hospice care, had a documented allergy or hypersensitivity to glucagon, already had glucagon prescribed prior to appointment, or if the patient was hospitalized at the time of outreach for any other condition other than hypoglycemia.
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Patrick Middle name B Last name Gregory
Organization	Duke University Health Systems
Division name	Pharmacy
Zip code	27707
Address	3100 Tower Blvd, Ste 1100, Durham, NC 27707
TEL	919.660.0697
Email	patrick.gregory@duke.edu

Public contact
Name of contact person	1st name Benjamin Middle name H Last name Smith
Organization	Duke University Health Systems
Division name	Pharmacy
Zip code	27707
Address	3100 Tower Blvd, Ste 1100, Durham, NC 27707
TEL	919.660.0673
Homepage URL
Email	benjamin.smith@duke.edu

Sponsor
Institute	Duke University Health Systems
Institute
Department

Funding Source
Organization	Duke University Health Systems
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Patrick B Gregory
Name of secondary funder(s)

IRB Contact (For public release)
Organization	DUHS IRB Office
Address	2424 Erwin Road, Durham, NC 27705
Tel	919.668.5111
Email	ResearchServiceDesk@duke.edu

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Duke University Health Systems

Other administrative information
Date of disclosure of the study information	2026 Year 10 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	343
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 10 Month 01 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 22 Day
Last modified on	2021 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052317