Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)

September 11, 2019 updated by: Jaeb Center for Health Research

Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • University of Southern California
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Barbara Davis Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32804
        • Florida Hospital Diabetes Institute
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associates
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Columbia University - Naomi Berrie Diabetes Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • University of North Carolina
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington Diabetes Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 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.
Device: 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time spent with glucose level <70 mg/dL
Time Frame: 6 months (26 weeks) from baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in HbA1c from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be computed for each randomization group and compared in a regression model adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Change in QOL: Preferring Hypoglycemia Scale
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Change in QOL: Hypoglycemia Fear Survey
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Change in QOL: Diabetes Distress Questionnaire
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Change in QOL: PROMIS Measures for QOL
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Change in QOL: NIH Cognitive Toolbox
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Change in QOL: NIH Emotions Toolbox
Time Frame: 6 months (26 weeks) from baseline
Mean ± SD values for the change in total and composite score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
6 months (26 weeks) from baseline
Time spent with glucose level <60 mg/dL
Time Frame: 6 months (26 weeks) from baseline
Analyses will be similar to the primary objective.
6 months (26 weeks) from baseline
Time spent with glucose level <54 mg/dL
Time Frame: 6 months (26 weeks) from baseline
Analyses will be similar to the primary objective.
6 months (26 weeks) from baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of episodes of severe hypoglycemia
Time Frame: baseline to 6 months (26 weeks)
A hypoglycemic event will be defined as severe low blood sugar requiring assistance of another person due to altered or loss of consciousness. The rate of episodes will be tabulated and assessed using a regression model adjusted for baseline number of events.
baseline to 6 months (26 weeks)
Rate of episodes of diabetic ketoacidosis events
Time Frame: baseline to 6 months (26 weeks)

A diabetic ketoacidosis event will be defined as hyperglycemia meeting all of the following criteria:

  • Symptoms such as polyuria, polydipsia, nausea, or vomiting;
  • Serum ketones >1.5 mmol/L or large/moderate urine ketones;
  • Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15; and
  • Treatment provided in a health care facility

The rate of episodes of diabetic ketoacidosis will be tabulated and assessed using a regression model adjusted for baseline number of events.
baseline to 6 months (26 weeks)
Number of falls
Time Frame: baseline to 6 months (26 weeks)
The number of falls and any resulting injuries will be tabulated and compared between treatment groups using a Fisher's exact test.
baseline to 6 months (26 weeks)
Number of ER visits
Time Frame: baseline to 6 months (26 weeks)
The number of ER visits will be tabulated and compared between treatment groups using a Fisher's exact test.
baseline to 6 months (26 weeks)
Number of hospitalizations
Time Frame: baseline to 6 months (26 weeks)
The number of hospitalizations will be tabulated and compared between treatment groups using a Fishers's exact test.
baseline to 6 months (26 weeks)
Number of device-related adverse events
Time Frame: baseline to 6 months (26 weeks)

The study investigator will determine if an adverse event (severe hypoglycemic events, diabetic ketoacidosis events, falls, hospitalizations, ER visits, etc.) may have been caused by the study intervention (CGM) by any of the following:

  • Component disconnections
  • CGM sensors lasting fewer than 7 days
  • CGM tape adherence issues
  • Battery lifespan deficiency due to inadequate charging or extensive wireless communication
  • Intermittent device component disconnections/communication failures not leading to system replacement
  • Device issues clearly addressed in the user guide manual that do not require additional troubleshooting
  • Skin reactions from CGM sensor placement that don't meet criteria for AE reporting

The number of device-related adverse events will be tabulated and compared between treatment groups using a Fisher's exact test.
baseline to 6 months (26 weeks)
Hyperglycemia: time >180 mg/dL
Time Frame: 6 months (26 weeks) from baseline
Time spent >180 mg/dL will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline
Hyperglycemia: time >250 mg/dL
Time Frame: 6 months (26 weeks) from baseline
Time spent >250 mg/dL will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline
Hyperglycemia: time >300mg/dL
Time Frame: 6 months (26 weeks) from baseline
Time spent >300mg/dL will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline
Hyperglycemia: area under the curve 180 mg/dL
Time Frame: 6 months (26 weeks) from baseline
The area under the curve for 180 mg/dL will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline
Hyperglycemia: high blood glucose index
Time Frame: 6 months (26 weeks) from baseline
High blood glucose index will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline
Time in range 70-180 mg/dL
Time Frame: 6 months (26 weeks) from baseline
The time in range (70-180 mg/dL) will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline
Mean glucose
Time Frame: 6 months (26 weeks) from baseline
Mean glucose will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline
Glycemic variability (coefficient of variation)
Time Frame: 6 months (26 weeks) from baseline
Glycemic variability will be compared between groups using the methods described above for the primary objective.
6 months (26 weeks) from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaeb Center for Health Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Juvenile Diabetes Research Foundation
The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kellee Miller, Jaeb Center for Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WisDM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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