Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Jaeb Center for Health Research
- Enrollment
- 200
- Locations
- 22
- Primary Endpoint
- Time spent with glucose level <70 mg/dL
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in QOL: NIH Cognitive Toolbox(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: PROMIS Measures for QOL(6 months (26 weeks) from baseline)
- Time spent with glucose level <60 mg/dL(6 months (26 weeks) from baseline)
- Time spent with glucose level <54 mg/dL(6 months (26 weeks) from baseline)
- Change in QOL: NIH Emotions Toolbox(6 months (26 weeks) from baseline)
- Change in HbA1c(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)