Effects of Glucose Fluctuation Intervention on the Prognosis of Patients With Type 2 Diabetes and Cerebral Infarction

Nanjing University of Traditional Chinese Medicine

Status: Unknown

Conditions: Type 2 Diabetes and Cerebral Infarction

Treatments: Behavioral: Glucose fluctuation targeted intervention; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03932084

N2017003

Details and patient eligibility

About

The present randomized control trial sought to establish glucose fluctuation as an important target for management on metabolic index, neurologic function, and quality of life in Type 2 diabetes mellitus (T2DM) patients and cerebral infarction (CI).

Full description

There is a significant association between glycemic fluctuation and the incidence of diabetes macrovascular complications. Therefore, understanding the impact of glycemic fluctuations on diabetic macroangiopathy could be helpful for discovering a strategy of prevention and treatment of macroangiopathy in diabetes. However, previous studies on the glycemic fluctuation in T2DM patients with CI were cross-sectional studies, there has been no prospective intervention study confirming the effects of glucose fluctuation targeted management on the prognosis of T2DM patients following CI. Based on previous fingdings, investigators will assess the effects of glucose fluctuation targeted intervention on metabolic index, neurologic function, and quality of life in T2DM patients and CI.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. cerebral infarction within one month, diagnosed by magnetic resonance imaging (MRI) or computed tomography (CT) according to 1995 acute cerebral infarction diagnosis standards promulgated by the Fourth National Cerebrovascular Disease Conference [1];
• 2. having type 2 diabetes mellitus (as defined by the WHO diagnostic criteria in 1999) [2];

Exclusion criteria

• 1. coexisting acute complications of diabetes including diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), metabolic acidosis;
• 2. severe comorbid chronic complications of diabetes;
• 3. active malignancy;
• 4. subjects with mental illness and communication disorders; 5) those actively participating in other research studies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Control group

Experimental group

Description:

During hospitalization: 1. Monitor subjects' blood glucose; 2. One-on-one education: Education includes skills related to diabetes self-management, basic knowledge of diabetes, diet, exercise, medication, blood glucose monitoring, risks of glucose fluctuations; 3. Teaching patients and their families to use blood glucose meters and correctly record results. The diabetes specialist nurses demonstrate correct methods for self-monitoring blood glucose. During discharge: Patients were given standard hospital discharge instructions and were asked to monitor their blood glucose 5 times daily after discharge. Follow-up: If a patient FPG was less than 7 mmol/L, 2hPG was less than 10 mmol/L, or A1c was less than 7%, no intervention would be implemented. If one of these items was above the numbers, a referral would be made to an endocrinologist for medication adjustment. Participants received telephone follow-up one week after discharge, thereafter, follow-up were conducted once a month.

Treatment:

Behavioral: Control group

Glucose fluctuation targeted intervention

Experimental group

Description:

We set achieving goals for this intervention group (both A1c\<7% and LAGE\<80mg/dl). Participants received the same usual care as the control group; though additional attention was paid to glucose fluctuation on the basis of glucose control. Even the patient's FPG, 2hPG, and A1c were all well controlled, If his or her LAGE≥80mg/dl, we would carefully assess the patient's diet and exercise and daily activities first. If it was caused by lifestyle or events, the researchers worked with patients to find a self-care behavioral solution for the glucose fluctuation, and set behavioral goals, otherwise, the researchers would refer the patient to an endocrinologist for medication adjustment. During next follow-up, we evaluated the glucose fluctuation and target completion.

Treatment:

Behavioral: Glucose fluctuation targeted intervention