Simplified Insulin Protocol Using Lantus in Elderly

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: Glargine

• Registration Number: NCT01480843
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-29
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2017-04-25
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-09
• Last Update Submitted: 2017-10-09
• Results First Posted: 2017-11-08
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Duration of Hypoglycemia Episodes	baseline, 5 months, 8 months	duration of hypoglycemia measured by continuous glucose monitoring
Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months	baseline, 5 months, 8 months	frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States