Effect of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Pharmaceutical care and insulin staging.
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus., Insulin Staging., Pharmaceutical care.
Eligibility Criteria
Inclusion Criteria:
- T2DM patients.
- Patients must be on insulin therapy
- Willing to participate in the study
Exclusion Criteria:
- T1DM
- T2DM patients whose not on insulin therapy
- Patients that have disabilities that interfere with compliances towards medications
Sites / Locations
- College of Pharmacy-University of SulaimaniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non-Intervention Group
Intervention Group
Arm Description
Patients in the non-intervention group will be followed for the therapeutic outcomes and detection of DTPs without tempting to resolve them
A strict protocol developed by IDC for insulin prescription is going to be implement and patients will be assessed for the therapeutic outcomes along with the detection and resolution of drug therapy problems throughout the course
Outcomes
Primary Outcome Measures
Mean change of glycated hemoglobin (HbA1c).
HbA1c refers to glycated hemoglobin (A1c) , which identifies average plasma glucose concentration (in %).
Measurement of Lipid profile (LDL, HDL, cholesterol and triglyceride)
Lipid profile refers to pattern of lipids in the blood (in mg/dL). A lipid profile usually includes the levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, and the calculated low-density lipoprotein (LDL) 'cholesterol.
Measurement of Drug therapy problems (DTP).
Drug therapy problem (DTP) refers to any unwanted incident related to medication therapy that actually or potentially affects the desired goals of treatment.
Fasting plasma glucose (FPG)
FPG measures the levels of glucose in the plasma (in mg/dL).To assess the effect of insulin on the FPG level.
Secondary Outcome Measures
Body Weight.
Body Weight: the amount that a person weighs (in kg), To find out whether the patient is obese or not.
Full Information
NCT ID
NCT05244200
First Posted
January 7, 2022
Last Updated
February 7, 2022
Sponsor
University of Sulaimani
1. Study Identification
Unique Protocol Identification Number
NCT05244200
Brief Title
Effect of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus
Official Title
The Impact of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sulaimani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The number of people with diabetes rose from 108 million in 1980 to 422 million in 2014. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation. Current challenges in diabetes management include: (1) optimizing the use of currently available therapies to ensure adequate glycemic control and to reduce complications; (2) educating patients on diabetes self-management; (3) improving patient adherence to lifestyle and pharmacologic interventions; ; and (4) reducing barriers to the early use of insulin. In this research, the impact of pharmaceutical care and Insulin staging will be evaluated in patients with type 2 diabetes to overcome this challenges. The concept of "pharmaceutical care" was first introduced by Helper and Strand in 1990, pushing for the transformation of the Pharmacy profession from "product-focused" to "patient-centric". Pharmaceutical care is a patient-centered practice in which the practitioner assumes responsibility for a patient's drug-related needs and is held accountable for this commitment. Due to the progressive nature of the disease, which requires timely optimization of treatment, leading in a majority of cases to insulin therapy, so that proper use of insulin is one of the critical tools for prevention of long-term complications. From the hundred patients in this study, half of the patients will be the control group without any intervention, and pharmaceutical care and insulin staging will be applied on the remaining. In this research two strategies will be applied including pharmaceutical care process and Insulin Staging approach on patients with T2DM, those who are on end stage treatment.
Detailed Description
In 2018, 34.2 million Americans, or 10.5% of the population, had diabetes.
Of the 34.2 million adults with diabetes, 26.8 million were diagnosed, and 7.3 million were undiagnosed
The percentage of Americans age 65 and older remains high, at 26.8%, or 14.3 million seniors (diagnosed and undiagnosed).
Diabetes Mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia and abnormalities in carbohydrate, fat, and protein metabolism.
It results from defects in insulin secretion, insulin sensitivity, or both. Chronic microvascular, macrovascular, and neuropathic complications may ensue .
One of the challenges facing the management of T2DM is the lack of an established guideline for Insulin administration in most of the communities.
Considering the slogan of clinical pharmacy: safe, cost-effectiveness of medication, there are many Insulin products available and often doctors get confused on Choosing the right drug for the right patient.
The hypothesis of this study is that clinical pharmacist Intervention through applying Pharmaceutical care and insulin staging has significant impact on quality of life and therapeutic outcomes of patients with Type II Diabetes With the end stage management protocol, while the null hypothesis states that there is no correlation between clinical pharmacist intervention with patient's quality of life and therapeutic outcomes.
Study design: two-arm randomized, selective control trial.
Interventions: Insulin Staging in the context of Pharmaceutical Care.
Number of participants = 100.
Number of groups = 2 groups each of 50 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus., Insulin Staging., Pharmaceutical care.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In these selective control trial, 100 patients with type 2 diabetes mellitus, those that they are on the end stage management protocol are going to be randomly allocated into two different groups, namely intervention and non-intervention groups. In the intervention group, a strict protocol developed by IDC for insulin prescription is going to be implement and patients will be assessed for the therapeutic outcomes along with the detection and resolution of drug therapy problems throughout the course of 6 months study. On the side, patients in the non-intervention group will be followed for the therapeutic outcomes and detection of DTPs without tempting to resolve them.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-Intervention Group
Arm Type
No Intervention
Arm Description
Patients in the non-intervention group will be followed for the therapeutic outcomes and detection of DTPs without tempting to resolve them
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
A strict protocol developed by IDC for insulin prescription is going to be implement and patients will be assessed for the therapeutic outcomes along with the detection and resolution of drug therapy problems throughout the course
Intervention Type
Other
Intervention Name(s)
Pharmaceutical care and insulin staging.
Intervention Description
Pharmaceutical care is a patient-centered practice in which the practitioner assumes responsibility for a patient's drug-related needs and is held accountable for this commitment. Due to the progressive nature of Type 2 Diabetes Mellitus, which requires timely optimization of treatment, leading in a majority of cases to insulin therapy, so that proper use of insulin is one of the critical tools for prevention of long-term complications. From the hundred patients in this study, half of the patients will be the control group without any intervention, and pharmaceutical care and insulin staging will be applied on the remaining. In this research two strategies will be applied including pharmaceutical care process and Insulin Staging approach on patients with T2DM, those who are on end stage treatment.
Primary Outcome Measure Information:
Title
Mean change of glycated hemoglobin (HbA1c).
Description
HbA1c refers to glycated hemoglobin (A1c) , which identifies average plasma glucose concentration (in %).
Time Frame
Up to 6 months.
Title
Measurement of Lipid profile (LDL, HDL, cholesterol and triglyceride)
Description
Lipid profile refers to pattern of lipids in the blood (in mg/dL). A lipid profile usually includes the levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, and the calculated low-density lipoprotein (LDL) 'cholesterol.
Time Frame
Up to 6 months.
Title
Measurement of Drug therapy problems (DTP).
Description
Drug therapy problem (DTP) refers to any unwanted incident related to medication therapy that actually or potentially affects the desired goals of treatment.
Time Frame
Up to 6 months.
Title
Fasting plasma glucose (FPG)
Description
FPG measures the levels of glucose in the plasma (in mg/dL).To assess the effect of insulin on the FPG level.
Time Frame
Up to 6 months.
Secondary Outcome Measure Information:
Title
Body Weight.
Description
Body Weight: the amount that a person weighs (in kg), To find out whether the patient is obese or not.
Time Frame
Up to 6 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T2DM patients.
Patients must be on insulin therapy
Willing to participate in the study
Exclusion Criteria:
T1DM
T2DM patients whose not on insulin therapy
Patients that have disabilities that interfere with compliances towards medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kawa Obeid, PhD
Phone
009647501112412
Email
kawa.uobaed@univsul.edu.iq
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Hamasaeed, BSc
Phone
009647722145660
Ext
Ahmad
Email
ahmed.hamasaeed@univsul.edu.iq
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kawa Obeid, PhD
Organizational Affiliation
Clinical Pharmacy Department/ College of Pharmacy/University of Sulaimani/ Kurdistan Region-Iraq.
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Pharmacy-University of Sulaimani
City
Sulaymaniyah
ZIP/Postal Code
00964
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kawa Obeid, PhD
Phone
009647501112412
Email
kawa.uobaed@univsul.edu.iq
First Name & Middle Initial & Last Name & Degree
Ahmed Hamasaeed, BSc
Phone
009647722145660
Email
ahmed.hamasaeed@univsul.edu.iq
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Whittlesea C, Hodson K. Clinical pharmacy and therapeutics. Elsevier 2019.
Results Reference
background
PubMed Identifier
28464300
Citation
Saseen JJ, Ripley TL, Bondi D, Burke JM, Cohen LJ, McBane S, McConnell KJ, Sackey B, Sanoski C, Simonyan A, Taylor J, Vande Griend JP. ACCP Clinical Pharmacist Competencies. Pharmacotherapy. 2017 May;37(5):630-636. doi: 10.1002/phar.1923. Epub 2017 May 2.
Results Reference
background
Citation
Cipolle RJ, Strand LM, Morley PC. Pharmaceutical care practice: the clinician's guide. 2nd ed. New York: McGraw-Hill, Medical Pub. Division; 2004. 394 p.
Results Reference
background
PubMed Identifier
25247007
Citation
Chumney EC, Robinson LC. The effects of pharmacist interventions on patients with polypharmacy. Pharm Pract (Granada). 2006 Jul;4(3):103-9.
Results Reference
background
Citation
Mansour A, Al Douri F. Diabetes in Iraq: Facing the Epidemic. A systematic Review. Wulfenia. 2015;22(3):258.
Results Reference
background
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Effect of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus
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