Clinical trial NCT03240432: Wireless Innovation for Seniors With Diabetes Mellitus
Official title: Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
name: Juvenile Diabetes Research Foundation
First posted: 2017-08-07
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve quality of life including reducing hypoglycemic fear and diabetes distress. Despite these potential benefits, CGM is used by only a small proportion of older adults with T1D. Previous studies assessing CGM efficacy have included only a small number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia, focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors. These studies are not generalizable to the population of older adults with T1D. The potential benefit of CGM in reducing hypoglycemia in the older adult population has not been well studied. The goal of this study is to assess the potential benefits and risks of CGM in older adults with T1D.

Eligibility criteria: 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:

   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:
   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 240 hours (10 out of 14 days) of sensor glucose data with appropriate number of calibrations from the blinded CGM pre-randomization phase

Exclusion Criteria:

Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation.

1. 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 (see section 8.1).
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 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.

Primary outcomes:
measure: Time spent with glucose level <70 mg/dL
timeFrame: 6 months (26 weeks) from baseline
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 6 months (26 weeks) from baseline
measure: Change in QOL: Preferring Hypoglycemia Scale
timeFrame: 6 months (26 weeks) from baseline
measure: Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire
timeFrame: 6 months (26 weeks) from baseline
measure: Change in QOL: Hypoglycemia Fear Survey
timeFrame: 6 months (26 weeks) from baseline
measure: Change in QOL: Diabetes Distress Questionnaire
timeFrame: 6 months (26 weeks) from baseline
measure: Change in QOL: PROMIS Measures for QOL
timeFrame: 6 months (26 weeks) from baseline
measure: Change in QOL: NIH Cognitive Toolbox
timeFrame: 6 months (26 weeks) from baseline
measure: Change in QOL: NIH Emotions Toolbox
timeFrame: 6 months (26 weeks) from baseline
measure: Time spent with glucose level <60 mg/dL
timeFrame: 6 months (26 weeks) from baseline
measure: Time spent with glucose level <54 mg/dL
timeFrame: 6 months (26 weeks) from baseline
Other outcomes:
measure: Rate of episodes of severe hypoglycemia
timeFrame: baseline to 6 months (26 weeks)
measure: Rate of episodes of diabetic ketoacidosis events
timeFrame: baseline to 6 months (26 weeks)
measure: Number of falls
timeFrame: baseline to 6 months (26 weeks)
measure: Number of ER visits
timeFrame: baseline to 6 months (26 weeks)
measure: Number of hospitalizations
timeFrame: baseline to 6 months (26 weeks)
measure: Number of device-related adverse events
timeFrame: baseline to 6 months (26 weeks)
measure: Hyperglycemia: time >180 mg/dL
timeFrame: 6 months (26 weeks) from baseline
measure: Hyperglycemia: time >250 mg/dL
timeFrame: 6 months (26 weeks) from baseline
measure: Hyperglycemia: time >300mg/dL
timeFrame: 6 months (26 weeks) from baseline
measure: Hyperglycemia: area under the curve 180 mg/dL
timeFrame: 6 months (26 weeks) from baseline
measure: Hyperglycemia: high blood glucose index
timeFrame: 6 months (26 weeks) from baseline
measure: Time in range 70-180 mg/dL
timeFrame: 6 months (26 weeks) from baseline
measure: Mean glucose
timeFrame: 6 months (26 weeks) from baseline
measure: Glycemic variability (coefficient of variation)
timeFrame: 6 months (26 weeks) from baseline
Locations:
city: Beverly Hills
country: United States
facility: University of Southern California
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: Aurora
country: United States
facility: University of Colorado - Barbara Davis Center
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Diabetes Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University - Naomi Berrie Diabetes Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington Diabetes Care Center
state: Washington
Study officials:
affiliation: Jaeb Center for Health Research
name: Kellee Miller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller KM, Kanapka LG, Rickels MR, Ahmann AJ, Aleppo G, Ang L, Bhargava A, Bode BW, Carlson A, Chaytor NS, Gannon G, Goland R, Hirsch IB, Kiblinger L, Kruger D, Kudva YC, Levy CJ, McGill JB, O'Malley G, Peters AL, Philipson LH, Philis-Tsimikas A, Pop-Busui R, Salam M, Shah VN, Thompson MJ, Vendrame F, Verdejo A, Weinstock RS, Young L, Pratley R. Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):424-434. doi: 10.1089/dia.2021.0503. Epub 2022 Apr 11.
citation: Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928.