Wireless Innovation for Seniors With Diabetes Mellitus

NCT ID: NCT03240432

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2019-09-10

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Continuous Glucose Monitor group

CGM group participants will be asked to use a Dexcom CGM sensor on a daily basis, inserting a new sensor as needed. Participants will be instructed to use the sensor according to FDA labeling. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading. Participants will have clinic visits at 10 days, 4 weeks, 8 weeks, 16 weeks, and 26 weeks.

Group Type: ACTIVE_COMPARATOR

Dexcom CGM

Intervention Type: DEVICE

CGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick.

Blood Glucose Meter group

BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 4 times a day. Participants will be permitted to check a fingerstick glucose as many times a day as they choose. Participants will have a phone visits at 10 days and clinic visits at 4 weeks, 8 weeks, 16 weeks, and 26 weeks. In addition to the in-clinic study visits, the BGM group will have blinded sensor placement visits one week prior to each of the 8, 16, and 26 week visits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexcom CGM

CGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick.

Intervention Type: DEVICE

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

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kellee Miller

Role: PRINCIPAL_INVESTIGATOR

Jaeb Center for Health Research

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35294272 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32543682 (View on PubMed)

Other Identifiers

WISDM

Identifier Type: -

Identifier Source: org_study_id