Different Initial Insulin Dose Regimens on Time to Achieve Glycemic Targets and Treatment Safety in SIIT
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- STATUS
- Recruiting
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- days left to enroll
- 74
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- participants needed
- 56
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- sponsor
- Sun Yat-sen University
Summary
To compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes mellitus(T2DM) patients, in order to investigate the rational of formula based initiation regimen.
Description
Diabetes has become one of the major chronic non-communicable diseases. Its prevalence was rising in these years. Short-term intensive insulin therapy can improve the -cell function and nearly half of the patients can live with long-term glycemic remission. It has therefore become the recommended treatment for the newly diagnosis T2DM patients with high blood glucose. However, due to the glycemic goal for intensive therapy is strict, it's important to find out a suitable initial insulin regimen for continuous subcutaneous insulin infusion(CSII) with which patients can achieve euglycemia safely, stably and rapidly. In previous study, the investigators found out that the total daily insulin dose at the first day when euglycemia was achievedTDD-1 was associated with weight, waist circumference, triglycerides and fasting blood glucose levels. According to this, the investigators figured out a formula for estimation of insulin dose for the short-term intensive insulin therapy in patients with newly diagnosed T2DM. However, its feasibility needs to be further verified. Therefore, the investigators conducted this prospective randomized controlled study to compare the effects of different initial insulin dose regimens during the short-term insulin intensive treatment on time to glycemic goal, hypoglycemia prevalence, glycemic variability and other safety problems in newly diagnosed type 2 diabetes patients, in order to investigate the rational of formula based initiation regimen.
Details
| Condition | Diabetes (Pediatric), metabolism disorders, Metabolic Disorders, noninsulin-dependent diabetes mellitus, diabetes type 2, type 2 diabetes, type 2 diabetes mellitus, Diabetes Mellitus Types I and II, metabolic diseases, metabolic disease, endocrinopathy, Endocrine disorder, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, NIDDM, Diabetes Mellitus Type 2, endocrine disease, Diabetes Prevention, type ii diabetes, diabetes mellitus (dm), Diabetes Mellitus, Metabolic disorder, endocrine disorders, endocrine diseases |
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| Treatment | CSII with formula-based initial insulin regimen, CSII with weight-based initial insulin regimen |
| Clinical Study Identifier | NCT05084079 |
| Sponsor | Sun Yat-sen University |
| Last Modified on | 26 October 2021 |
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