Wireless Innovation for Seniors With Diabetes Mellitus

NCT03240432 | Completed DMC FDA Device

• 1 other identifier: WISDM
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 22

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Time spent with glucose level <70 mg/dL

  The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (\<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.

  6 months (26 weeks) from baseline

Secondary Outcomes (10)

• Change in HbA1c

  6 months (26 weeks) from baseline

• Change in QOL: Preferring Hypoglycemia Scale

  6 months (26 weeks) from baseline

• Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire

  6 months (26 weeks) from baseline

• Change in QOL: Hypoglycemia Fear Survey

  6 months (26 weeks) from baseline

• Change in QOL: Diabetes Distress Questionnaire

  6 months (26 weeks) from baseline

Other Outcomes (14)

• Rate of episodes of severe hypoglycemia

  baseline to 6 months (26 weeks)

• Rate of episodes of diabetic ketoacidosis events

  baseline to 6 months (26 weeks)

• Number of falls

  baseline to 6 months (26 weeks)

Study Arms (2)

Continuous Glucose Monitor group

ACTIVE COMPARATOR

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.

Device: Dexcom CGM

Blood Glucose Meter group

NO INTERVENTION

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.

Interventions

Dexcom CGM 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.

Continuous Glucose Monitor group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (22)

University of Southern California

Beverly Hills, California, 90211, United States

Location

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

University of Colorado - Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Florida Hospital Diabetes Institute

Orlando, Florida, 32804, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University - Naomi Berrie Diabetes Center

New York, New York, 10032, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington Diabetes Care Center

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• 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.

  PMID: 35294272 DERIVED

• 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.

  PMID: 32543682 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kellee Miller

  Jaeb Center for Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 7, 2017
• Study Start: September 26, 2017
• Primary Completion: June 6, 2019
• Study Completion: September 10, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (22)