Simplified Insulin Protocol Using Lantus in Elderly (SIMPLE)

October 9, 2017 updated by: Joslin Diabetes Center

Simplification of Diabetes Regimen in Elderly Patients Using Glargine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glargine
We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.
Drug: Glargine
Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
Other Names:
  • Lantus

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

Sanofi

Investigators

  • Principal Investigator: Medha N Munshi, MD, Joslin Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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