Simplified Insulin Protocol Using Lantus in Elderly (SIMPLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01480843
Recruitment Status : Completed
First Posted : November 29, 2011
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Glargine Phase 4

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  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simplification of Diabetes Regimen in Elderly Patients Using Glargine
Study Start Date : June 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

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 Name: Lantus

Primary Outcome Measures :
  1. Change in Duration of Hypoglycemia Episodes [ Time Frame: baseline, 5 months, 8 months ]
    duration of hypoglycemia measured by continuous glucose monitoring

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01480843

United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Principal Investigator: Medha N Munshi, MD Joslin Diabetes Center

Bonsignore P DL, Suhl E, Sternthal A, Giusti J, Munshi MN. Unrecognized Errors in Insulin Injection Techniques Are Frequent in Older Adults Even with Longer Duration of Insulin Use. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 913-P.
Medha N. Munshi EB, Ramachandiran Cooppan. Diabetes in the Older Adult. In: Richard S. Beaser MatSoJDC, ed. Joslin's Diabetes Deskbook : A guide for primary care providers. 2nd ed. Boston: Joslin Diabetes Center; 2007:623-38.
McAulay V FB. Hypoglycemia in diabetes in old age. In: Sinclair A, Finucane P, ed. 2nd ed. Chichester, UK: John wiley and sons; 2001:133-52.
Ayres D SE, Capelson R, Weinger K, Munshi M. Identifying Barriers to Diabetes Education and Self-Care in Older Adults. In: American diabetes Association 65th scientific sessions 2005; San Diego CA; 2005. p. 941-P
Munshi MN DL, Iwata I, Suhl E, Giusti J, Bonsignore P, Sternthal A The Risk of Hypoglycemia Is a Treatment-Limiting Factor in Older Adults Even with Poor Glycemic Control. In: American Diabetes Association annual meeting 2009; 2009; New Orleans LA; 2009. p. 2123-PO.

Responsible Party: Joslin Diabetes Center Identifier: NCT01480843     History of Changes
Other Study ID Numbers: 2011-05
First Posted: November 29, 2011    Key Record Dates
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Joslin Diabetes Center:

Additional relevant MeSH terms:
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs