A Study of Continuous Glucose Monitoring in Individuals 60 Years Old or Older with Type 1 Diabetes

Overview

About this study

The primary objective of this study is to determine if continuous glucose monitoring (CGM) can reduce hypoglycemia and improve quality of life in older adults with type 1 diabetes (T1D).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

To be eligible for the study, all participants must meet the following criteria:

  1. Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator and meeting at least one of the following criteria: 
    1. Age > 6 months and < 10 years old at diagnosis OR
    2. Positive pancreatic autoantibodies at any time (GAD-65, IA-2, ICA or ZnT8) or positive anti-insulin autoantibody at diagnosis only (within 10 days of starting insulin) OR
    3. Presence of 2 or more of the following clinical indicators suggestive of type 1 diabetes:
      1. Age at diagnosis < 40 years
      2. Non-obese at diagnosis according to BMI (< 95th percentile pediatric and < 30 kg/m2 adult)
      3. Diabetic ketoacidosis (DKA) at any time,
      4. Plasma C-peptide level < 0.8 ng/ml (with blood glucose > 80 mg/dL if available) at any time
      5. Family history of type 1 diabetes in a first degree relative (parent, sibling, or child).
  2. Age ≥60 years
  3. HbA1c <10.0% at screening or within 30 days prior to screening visit (the upper limit was selected as a surrogate measure of likelihood of adherence to the protocol with the belief that those with higher HbA1c levels are generally noncompliant with diabetes management and thus not good candidates for the trial)
  4. Insulin regimen involves either use of an insulin pump (a minimum of 40% of study population) or multiple daily injections of insulin (minimum of 40% of study population).
  5. Participant is able to manage his/her diabetes with respect to insulin administration and glucose monitoring (which may include assistance from spouse or other caregiver)
  6. Participant understands the study protocol and agrees to comply with it
  7. Participant comprehends written and spoken English
  8. At least hours (10 out of 14 days) of sensor glucose data with appropriate number of calibrations from the blinded CGM pre-randomization phase

Exclusion Criteria:

  1. Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation. Use of unblinded CGM, outside of a research study, as part of real-time diabetes management in the last 3 months
  2. At least 10% of time spent with sensor glucose levels < 54 mg/dl during the blinded CGM screening period AND a severe hypoglycemic event in the past 6 months (a severe hypoglycemic event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
  3. Extreme visual or hearing impairment that would impair ability to use real-time CGM assessed at screening visit
  4. Known adhesive allergy or skin reaction during the blinded CGM pre-randomization phase that would preclude participation in the randomized trial
  5. Plans to begin non-insulin medication for blood glucose lowering during the course of the study
  6. Stage 4 or 5 renal disease or most recent GFR < 30 ml/min/m2 from local lab within the past 6 months
  7. The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with 482 life expectancy of <1 year.
  8. Clinical diagnosis of dementia (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)
  9. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial (unless stipulation no longer required with use of newer generation sensors)
  10. Inpatient psychiatric treatment in the past 6 months
  11. Participation in an intervention study (including psychological studies) in past 6 weeks.
  12. Expectation that participant will be moving out of the area of the clinical center during the next 6 months, unless the move will be to an area served by another study center.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yogish Kudva, M.B.B.S.

Open for enrollment

Contact information:

Shelly McCrady-Spitzer M.S.

(507)255-5916

McCradySpitzer.Shelly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20347032

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