Simplified Insulin Protocol Using Lantus in Elderly (SIMPLE)

Joslin Diabetes Center

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: Glargine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01480843

2011-05

Details and patient eligibility

About

The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

Full description

As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Enrollment: 65 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 70 years or older
• Diagnosis of diabetes mellitus Type II
• At least 2 (short-acting or mixed) insulin injections per day
• At least 1 episode of hypoglycemia (glucose value <70) on screening CGM

Exclusion criteria

• Patients with the following illnesses in the past 12 months Myocardial infarction Angina Coronary artery bypass grafting Percutaneous transluminal coronary angiography Cerebrovascular event (stroke, TIA)
• Active liver disease (history of cirrhosis or LFT > 3 times normal)
• On dialysis or with severe renal dysfunction (creatinine clearance <20 ml/min)
• Malignancy that limits life span to less than 18 months
• Patients seen in the geriatric clinic who already have simplified regimen as proposed in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Glargine

Experimental group

Description:

We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.

Treatment:

Drug: Glargine