Wireless Innovation for Seniors With Diabetes Mellitus

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve quality of life in older adults with T1D.

Key facts

Study ID: NCT03240432
Run by: Jaeb Center for Health Research
People needed: 200
Starts: 2017-09-26
Expected to finish: 2019-09-10
Last updated by the study team: 2019-09-12

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

To be eligible for the study, all participants must meet the following criteria:
Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator and meeting at least one of the following criteria:
i. Age > 6 months and < 10 years old at diagnosis OR ii. 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 iii. Presence of 2 or more of the following clinical indicators suggestive of type 1 diabetes:
Age at diagnosis < 40 years
Non-obese at diagnosis according to BMI (< 95th percentile pediatric and < 30 kg/m2 adult)
Diabetic ketoacidosis (DKA) at any time,
Plasma C-peptide level < 0.8 ng/ml (with blood glucose > 80 mg/dL if available) at any time
Family history of type 1 diabetes in a first degree relative (parent, sibling, or child).
Age ≥60 years
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)
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).
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)
Participant understands the study protocol and agrees to comply with it
Participant comprehends written and spoken English
At least 240 hours (10 out of 14 days) of sensor glucose data with appropriate number of calibrations from the blinded CGM pre-randomization phase

You may not qualify if…

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
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 (see section 8.1).
Extreme visual or hearing impairment that would impair ability to use real-time CGM assessed at screening visit
Known adhesive allergy or skin reaction during the blinded CGM pre-randomization phase that would preclude participation in the randomized trial
Plans to begin non-insulin medication for blood glucose lowering during the course of the study
Stage 4 or 5 renal disease or most recent GFR < 30 ml/min/m2 from local lab within the past 6 months
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 life expectancy of <1 year.
Clinical diagnosis of dementia (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)
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)
Inpatient psychiatric treatment in the past 6 months
Participation in an intervention study (including psychological studies) in past 6 weeks.
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.

Where it is running

University of Southern California — Beverly Hills, California, United States
Scripps Whittier Diabetes Institute — La Jolla, California, United States
University of Colorado - Barbara Davis Center — Aurora, Colorado, United States
University of Miami — Miami, Florida, United States
Florida Hospital Diabetes Institute — Orlando, Florida, United States
Atlanta Diabetes Associates — Atlanta, Georgia, United States
Northwestern University — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
University of Massachusetts — Worcester, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Henry Ford Health System — Detroit, Michigan, United States
International Diabetes Center — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University — St Louis, Missouri, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Columbia University - Naomi Berrie Diabetes Center — New York, New York, United States
SUNY Upstate Medical University — Syracuse, New York, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Oregon Health & Science University — Portland, Oregon, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
University of Washington Diabetes Care Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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