Effect of integrated care services on glycemic control and cardiovascular risk factors

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN83437562
• Lead Sponsor: Prince Sultan Military Medical City

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29291706

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-01-29
• Study Start: 2016-09-19
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

1. Age 18 and older
2. Diagnosed with Type 2 Diabetes Mellitus
3. Receiving care at the WHC
4. Had at least two clinic visits before the study
5. Can provide informed consent
6. Poor glycemic control (HbA1c level >10) (86 mmol/mol) or persistent elevation of HbA1c >8 (64 mmol/mol) for one year or more)
7. Failure to respond to therapeutic insulin dose of > 2 units/kg or 200 units irrespective of weight
8. Inadequate adherence to insulin
9. Uncontrolled hypertension or hyperlipidemia with a maximum possible combination of medications
10. Comorbidity such as cardiovascular, renal, or hepatic disease
11. Inadequate continuity of care (such as recurrent missed appointment for insulin titration)

Exclusion Criteria

1. Type 1 Diabetes Mellitus (these patients receive care from the Endocrinology department which will compromise the standardized level of care
2. Type 2 Diabetes Mellitus patients who receive care from Endocrinology department or other departments
3. Patients younger than 18 years old
4. Patients who cannot provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Glycated hemoglobin (HbA1c), measured from blood samples taken at baseline, 3, 6 and 9 months.<br>2. Lipid profile (HDL-cholesterol, LDL-cholesterol, Triglycerides), measured using commercial equipment (Dimension®, Dade Behring, Germany) at baseline, 3, 6 and 9 months<br>

Secondary Outcome Measures

Name	Time	Method
1. Fasting plasma glucose (FPG), measured using the fasting plasma glucose test using blood samples taken at baseline, 3 months, 6 months, and 9 months<br>2. Blood pressure, measured using a validated automatic sphygmomanometer (OMRON M4-I) when the participant is in a sitting position (weekly measurement for 9 months)<br>3. Weight measured in kg on a scale<br>4. BMI, calculated as the ratio between weight and height (kg/m2) at baseline, and 9 months<br>5. Serum cardiac troponin T (cTnT) and Creatine Kinase MB Isoenzyme (CK-MB), from blood taken at baseline, 3, 6, and 9 months