Effect of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus

NCT ID: NCT05244200

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2022-11-01

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-Intervention Group

Patients in the non-intervention group will be followed for the therapeutic outcomes and detection of DTPs without tempting to resolve them

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Pharmaceutical care and insulin staging.

Intervention Type: OTHER

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.

Interventions

Pharmaceutical care and insulin staging.

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sulaimani

OTHER

Sponsor Role: lead

Responsible Party

Kawa Ahmad Obeid

Head of the Department of Clinical Pharmacy.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kawa Obeid, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacy Department/ College of Pharmacy/University of Sulaimani/ Kurdistan Region-Iraq.

Locations

College of Pharmacy-University of Sulaimani

Sulaymaniyah, , Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Kawa Obeid, PhD

Role: CONTACT

kawa.uobaed@univsul.edu.iq

009647501112412

Ahmed Hamasaeed, BSc

Role: CONTACT

ahmed.hamasaeed@univsul.edu.iq

009647722145660 ext. Ahmad

Facility Contacts

Kawa Obeid, PhD

Role: primary

kawa.uobaed@univsul.edu.iq

009647501112412

Ahmed Hamasaeed, BSc

Role: backup

ahmed.hamasaeed@univsul.edu.iq

009647722145660

References

Whittlesea C, Hodson K. Clinical pharmacy and therapeutics. Elsevier 2019.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28464300 (View on PubMed)

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.

Reference Type: BACKGROUND

Chumney EC, Robinson LC. The effects of pharmacist interventions on patients with polypharmacy. Pharm Pract (Granada). 2006 Jul;4(3):103-9.

Reference Type: BACKGROUND

PMID: 25247007 (View on PubMed)

Mansour A, Al Douri F. Diabetes in Iraq: Facing the Epidemic. A systematic Review. Wulfenia. 2015;22(3):258.

Reference Type: BACKGROUND

Other Identifiers

College of Pharmacy/ UoS

Identifier Type: -

Identifier Source: org_study_id