Simplified Insulin Protocol Using Lantus in Elderly (SIMPLE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medha Munshi, Joslin Diabetes Center Identifier:
First received: November 9, 2011
Last updated: March 30, 2015
Last verified: March 2015
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 Intervention Phase
Drug: Glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Simplification of Diabetes Regimen in Elderly Patients Using Glargine

Resource links provided by NLM:

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Change in frequency and duration of hypoglycemia episodes [ Time Frame: baseline, 5 months, 8 months ] [ Designated as safety issue: Yes ]
    frequency and duration of hypoglycemia measured by continuous glucose monitoring

Estimated Enrollment: 65
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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: Medha Munshi, Director, Joslin Geriatric Diabetes Program, Joslin Diabetes Center Identifier: NCT01480843     History of Changes
Other Study ID Numbers: 2011-05 
Study First Received: November 9, 2011
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:

Additional relevant MeSH terms:
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 04, 2016