Type 2 Diabetes MellitusNCT05244200
Effect of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus
A study testing Pharmaceutical care and insulin staging. in people with Type 2 Diabetes Mellitus, run by University of Sulaimani at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pharmaceutical care and insulin staging.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 20 Jan 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- T2DM patients.
- Patients must be on insulin therapy
- Willing to participate in the study
Who cannot join
- T1DM
- T2DM patients whose not on insulin therapy
- Patients that have disabilities that interfere with compliances towards medications
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
College of Pharmacy-University of Sulaimani
Sulaymaniyah, 00964
Kawa Obeid, PhD, 009647501112412, kawa.uobaed@univsul.edu.iq
Ahmed Hamasaeed, BSc, 009647722145660, ahmed.hamasaeed@univsul.edu.iq
About this study
Official title: The Impact of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus
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.
Read the 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
- Being tested
- Pharmaceutical care and insulin staging.
- Keywords
- Type 2 Diabetes Mellitus., Insulin Staging., Pharmaceutical care.
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pharmaceutical care and insulin staging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of glycated hemoglobin (HbA1c).
HbA1c refers to glycated hemoglobin (A1c) , which identifies average plasma glucose concentration (in %).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months.
Secondary outcomes (1)
Body Weight.
Body Weight: the amount that a person weighs (in kg), To find out whether the patient is obese or not.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start20 Jan 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kawa Ahmad Obeid, University of Sulaimani
- Investigators
- Kawa Obeid, PhD, Principal investigator, Clinical Pharmacy Department/ College of Pharmacy/University of Sulaimani/ Kurdistan Region-Iraq.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244200
- Sponsor's protocol ID
- College of Pharmacy/ UoS
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whittlesea C, Hodson K. Clinical pharmacy and therapeutics. Elsevier 2019.
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.
PubMed 28464300Cipolle RJ, Strand LM, Morley PC. Pharmaceutical care practice: the clinician's guide. 2nd ed. New York: McGraw-Hill, Medical Pub. Division; 2004. 394 p.
Chumney EC, Robinson LC. The effects of pharmacist interventions on patients with polypharmacy. Pharm Pract (Granada). 2006 Jul;4(3):103-9.
PubMed 25247007Mansour A, Al Douri F. Diabetes in Iraq: Facing the Epidemic. A systematic Review. Wulfenia. 2015;22(3):258.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Insulin Staging in the Context of Pharmaceutical Care on Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05244200
- Acronym / sponsor ID
- College of Pharmacy/ UoS
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus., Insulin Staging., Pharmaceutical care.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Pharmaceutical care and insulin staging.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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- T2DM patients.
- Patients must be on insulin therapy
- Willing to participate in the study
Key exclusion criteria (3 listed)
- T1DM
- T2DM patients whose not on insulin therapy
- Patients that have disabilities that interfere with compliances towards medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention Group |
Primary outcome
Mean change of glycated hemoglobin (HbA1c).
Time frame: Up to 6 months.
HbA1c refers to glycated hemoglobin (A1c) , which identifies average plasma glucose concentration (in %).
Measurement of Lipid profile (LDL, HDL, cholesterol and triglyceride)
Time frame: Up to 6 months.
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).
Time frame: Up to 6 months.
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)
Time frame: Up to 6 months.
FPG measures the levels of glucose in the plasma (in mg/dL).To assess the effect of insulin on the FPG level.
1 secondary outcome
Body Weight.
Time frame: Up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- BackgroundWhittlesea C, Hodson K. Clinical pharmacy and therapeutics. Elsevier 2019.
- Background: PubMed 28464300Saseen 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.
- BackgroundCipolle 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: PubMed 25247007Chumney EC, Robinson LC. The effects of pharmacist interventions on patients with polypharmacy. Pharm Pract (Granada). 2006 Jul;4(3):103-9.
- BackgroundMansour A, Al Douri F. Diabetes in Iraq: Facing the Epidemic. A systematic Review. Wulfenia. 2015;22(3):258.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kawa Obeid, PhD principal investigator
Clinical Pharmacy Department/ College of Pharmacy/University of Sulaimani/ Kurdistan Region-Iraq.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care and insulin staging. in people with Type 2 Diabetes Mellitus, run by University of Sulaimani at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kawa Obeid, PhD (009647501112412, kawa.uobaed@univsul.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of glycated hemoglobin (HbA1c). (time frame: Up to 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244200, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.