Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.

Summary

Introduction Diabetes mellitus is a worrying global non-communicable disease where it is affecting 18.3% of Malaysian adults. Poorly managed diabetes leads to an array of serious complications, namely heart attack, kidney failure and stroke. Insulin therapy remains one of the most important medication in treating diabetes especially in the population with high sugar readings or long standing diabetes. Outpatient consultations for T2DM patients are spaced out due to the limited amount of treating physicians and clinic time. This resorts to the importance of outpatient patient-lead insulin titration. Different guidelines from local and international showed different basal insulin titration method in achieving ideal fasting blood sugar. Objective We aim to investigate the difference of basal insulin titration methods in reducing HbA1c among the T2DM patients. Methodology In a parallel group randomized controlled trial, we aim to recruit 70 adult T2DM patients who have poorly controlled T2DM ( HbA1c \> 7.5% with FPG \>8mmol/L) or newly diagnosed T2DM patients (who are symptomatic or HbA1c \>10% or FPG \>13 mmol/L). The subjects will be randomized to 2 groups, daily basal insulin titration and 3 daily basal insulin titration. These subjects will be follow up for 12 weeks (4th week and 8th week virtual consultation and 12th week face-to-face consultation). The primary outcome is the HbA1c reduction from baseline to the end of 12weeks intervention. The secondary outcomes are percentage of T2DM patients achieving fasting blood sugar within 4.4-7mmol/L and/or HbA1c \<7% within the study period, the incidence of hypoglycemia, total daily basal insulin dosage required to achieve desired fasting blood sugar, duration taken to achieve desired fasting blood sugar, weight changes and satisfaction to the therapy between the 2 intervention groups. Clinical Significance This study enables us to evaluate the efficacy of the different basal insulin titration methods among the T2DM patients.

Timeline

Start

2021-07-19

Primary completion

2022-08-31

Completion

2023-04-30

Publications

• Background Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.
• Background Davies M, Bain S, Charpentier G, Flacke F, Goyeau H, Woloschak M, Hasslacher C, Vespasiani G, Edelman S. A Randomized Controlled, Treat-to-Target Study Evaluating the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) Administered Using Either Device-Supported or Routine Titration in People With Type 2 Diabetes. J Diabetes Sci Technol. 2019 Sep;13(5):881-889. doi: 10.1177/1932296818821706. Epub 2019 Jan 15.
• Background Gerstein HC, Yale JF, Harris SB, Issa M, Stewart JA, Dempsey E. A randomized trial of adding insulin glargine vs. avoidance of insulin in people with Type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with Insulin Glargine for Hyperglycaemia Treatment) Study. Diabet Med. 2006 Jul;23(7):736-42. doi: 10.1111/j.1464-5491.2006.01881.x.
• Background American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.
• Background Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007 Nov;9(6):902-13. doi: 10.1111/j.1463-1326.2007.00804.x.

Drugs

Indications

No indication recorded.