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

NCT05244200 | Unknown DMC

• 1 other identifier: College of Pharmacy/ UoS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus.; Insulin Staging.; Pharmaceutical care.

Outcome Measures

Primary Outcomes (4)

• Mean change of glycated hemoglobin (HbA1c).

  HbA1c refers to glycated hemoglobin (A1c) , which identifies average plasma glucose concentration (in %).

  Up to 6 months.

• 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.

  Up to 6 months.

• 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.

  Up to 6 months.

• 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.

  Up to 6 months.

Secondary Outcomes (1)

• Body Weight.

  Up to 6 months.

Study Arms (2)

Non-Intervention Group

NO INTERVENTION

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

Intervention Group

EXPERIMENTAL

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

Other: Pharmaceutical care and insulin staging.

Interventions

Pharmaceutical care and insulin staging. 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.

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• T2DM patients.
• Patients must be on insulin therapy
• Willing to participate in the study

You may not qualify if:

• T1DM
• T2DM patients whose not on insulin therapy
• Patients that have disabilities that interfere with compliances towards medications

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (1)

College of Pharmacy-University of Sulaimani

Sulaymaniyah, 00964, Iraq

RECRUITING

Related Publications (5)

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

  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.

  PMID: 28464300 BACKGROUND

• 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.

  BACKGROUND

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

  PMID: 25247007 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kawa Obeid, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kawa Obeid, PhD

CONTACT

009647501112412; kawa.uobaed@univsul.edu.iq

Ahmed Hamasaeed, BSc

CONTACT

009647722145660; ahmed.hamasaeed@univsul.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Clinical Pharmacy.

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 17, 2022
• Study Start: January 20, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)