Protocol: Severe Hypoglycemia in Older Adults with Type 1 Diabetes: A Study to Identify Factors Associated with the Occurrence of Severe Hypoglycemia in Older Adults with T1D
Status: Closed
Start Date: 08/05/2013
End Date: 06/10/2014
Clinical Trial ID:  
Public Dataset:  Download

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A. Study Design

  • Case (severe hypoglycemia event in past 12 months) : Control (no severe hypoglycemia event in past 3 years)

B. Objectives

  • Identify factors associated with the occurrence of severe hypoglycemia in older adults with type 1 diabetes.

C. Major Eligibility Criteria

  • Clinical diagnosis of presumed autoimmune type 1 diabetes
  • Age ≥60 years old
  • Duration of T1D ≥20 years
  • Insulin presently required
  • Has not used a real-time CGM device for the past 2 weeks
  • Fluent in English

D. Treatment

  • Not Applicable

E. Duration of follow-up: None

F. Main Outcomes

  • Participants will be given the following tests and assessments
    • Montreal Cognitive Assessment
    • Symbol Digit Modalities Test
    • Trail Making Test
    • Hopkins Verbal Learning Test-Revised
    • Geriatric Depression Scale
    • Diabetes Numeracy Test (shortened version)
    • Functional Activities Questionnaire
    • Grooved Pegboard Test
    • Vision assessment
    • Hypoglycemic Unawareness Assessment- Clarke Survey
    • Hypoglycemia Fear Survey
    • Blood Glucose Attitudes Scale
    • Duke Social Support Scale
    • Failty 10 foor walk
    • Blinded continuous glucose monitoring for up to 14 days
    • Laboratory testing: HbA1c, non-fasting C-peptide, glucose, and creatine
    • Heart activity monitor for up to 14 days for a few participants from selected sites who are willing
    • Activity tracker device for up to 14 days for a few participants from selected sites who are willing

G. Sample Size

  • 100 cases and 100 controls (frequency matched by clinical site and age)


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