Type 1 Diabetes Mellitus
Conditions
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.
Interventions
DEVICEDexcom 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.
Sponsors
The Leona M. and Harry B. Helmsley Charitable Trust
Juvenile Diabetes Research Foundation
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent with glucose level <70 mg/dL | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in QOL: Preferring Hypoglycemia Scale | 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. |
| Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire | 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. |
| Change in QOL: Hypoglycemia Fear Survey | 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. |
| Change in QOL: Diabetes Distress Questionnaire | 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. |
| Change in HbA1c | 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. |
| Change in QOL: NIH Cognitive Toolbox | 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. |
| Change in QOL: NIH Emotions Toolbox | 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. |
| Time spent with glucose level <60 mg/dL | 6 months (26 weeks) from baseline | Analyses will be similar to the primary objective. |
| Time spent with glucose level <54 mg/dL | 6 months (26 weeks) from baseline | Analyses will be similar to the primary objective. |
| Change in QOL: PROMIS Measures for QOL | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time in range 70-180 mg/dL | 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. |
| Number of falls | 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. |
| Glycemic variability (coefficient of variation) | 6 months (26 weeks) from baseline | Glycemic variability will be compared between groups using the methods described above for the primary objective. |
| Mean glucose | 6 months (26 weeks) from baseline | Mean glucose will be compared between groups using the methods described above for the primary objective. |
| Number of ER visits | 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. |
| Number of hospitalizations | baseline to 6 months (26 weeks) | The number of hospitalizations will be tabulated and compared between treatment groups using a Fishers's exact test. |
| Rate of episodes of severe hypoglycemia | 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. |
| Rate of episodes of diabetic ketoacidosis events | 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. |
| Number of device-related adverse events | 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. |
| Hyperglycemia: time >180 mg/dL | 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. |
| Hyperglycemia: time >250 mg/dL | 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. |
| Hyperglycemia: time >300mg/dL | 6 months (26 weeks) from baseline | Time spent \>300mg/dL will be compared between groups using the methods described above for the primary objective. |
| Hyperglycemia: area under the curve 180 mg/dL | 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. |
| Hyperglycemia: high blood glucose index | 6 months (26 weeks) from baseline | High blood glucose index will be compared between groups using the methods described above for the primary objective. |
Countries
United States
Outcome results
None listed