Clinical trial NCT03078491: Technological Advances in Glucose Management in Older Adults
Official title: Technological Advances in Glucose Management in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Older Adults
Hypoglycemia
Keywords: type 1 diabetes
geriatrics
older adults
technology
CGM
clinical decision support
hypoglycemia
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Boston Children's Hospital
name: RTI International
First posted: 2017-03-13
Enrollment: 168
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to assess the effectiveness of CGM (Continuous Glucose Monitor), enhanced by a diabetes management platform (DMP), collectively called enhanced CGM (eCGM), in the care of older patients with T1D. The DMP includes an automated data transfer from CGM, insulin-delivery devices, and activity tracker to a clinical decision support system (CDS) that provides dosing adjustment recommendations based on that data to the healthcare team. In addition, the DMP includes on-demand education for patients and caregivers, and an interface for communication between providers, patients, and their caregivers.

Detailed description: Hypoglycemia is a major and often devastating complication of T1D in the elderly. CGM has been shown to reduce the risk for hypoglycemia in adults with T1D including some more functional patients over 65 years old. However, the Medicare population is heterogeneous and may have age-related clinical and functional impairments that can impact self-care. These patients will require additional targeted guidance and support to fully realize the potential benefits of CGM. To address these age-specific barriers which could limit the effective use of CGM, in our planned RCT (Specific Aim 1) the use of CGM will be coupled with the DMP (Diabetes Management Platform), a tablet-based technology platform ( termed enhanced CGM (eCGM)). The CGM, insulin delivery, and activity data uploaded from the DMP will be analyzed by the clinical decision support system (CDS), which will provide insulin dosing recommendations to the study physicians, who will then accept or reject changes in therapy. The use of the DMP is expected to help the less technologically proficient Medicare patients to derive benefit from CGM. Specific Aim 2 will involve extensive mixed methods research (including semi-structured interviews of patients and caregivers) directed at making an in-depth assessment of barriers to the use of diabetes technology in older adults. This investigation will provide the evidence-base for future improvements in both the technology and clinical approach to the training of older adults and their caregivers. Specific Aim 3 will involve a cost-effectiveness analysis of the technology system (CGM with DMP = enhanced CGM \[eCGM\]) used in the trial as well as quality of life measures, providing a foundation for decision-making on coverage.

Eligibility criteria: Inclusion Criteria:

* Patients with age ≥ 65 years
* Community-living
* Clinical diagnosis of T1D
* On multiple insulin injections (≥3 injection/s day) or insulin pump.

Exclusion Criteria:

* Use of real-time CGM in past 2 years
* A1c \> 10% (since individuals with very poor glycemic control usually have barriers to optimal self-care that preclude effective use of technology)
* Use of insulin pump that cannot be uploaded for CDS
* Unable or unwilling to perform task needed for study participation during the run-in period
* Severe vision or hearing impairment that could interfere with study tasks
* Need to use acetaminophen on regular basis (since can interfere with CGM accuracy)
* Living in an institutional setting (e.g. group homes, nursing homes)
* Terminal diseases with life expectancy \< 1 year (e.g. malignancy)
* Severe comorbidities that prevent completing outcome measurements (e.g. severe dementia, severe vision impairment, severe functional disabilities, inability to perform basic activities of daily living)
* Alcohol or other drug abuse
* Conditions that impact wear of CGM (e.g. CHF with edema, skin conditions); and
* End stage renal insufficiency (eGFR\<30), or on dialysis (since impact of fluid shift on sensor lag not clearly understood).

Primary outcomes:
measure: Change in duration of hypoglycemia
timeFrame: change of duration of hypoglycemia(minutes/day) from baseline to 6 months between intervention and control groups
Secondary outcomes:
measure: Fasting and bedtime CGM glucose values per day
timeFrame: change in glucose values(mg/dl) from baseline to 6 months between intervention and control groups
measure: Severe biochemical hypoglycemia
timeFrame: change in severe biochemical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups
measure: Severe clinical hypoglycemia
timeFrame: change in severe clinical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups
measure: Hemoglobin A1C
timeFrame: Change in A1C (%) from baseline to 6 months between intervention and control groups
measure: Cost-effectiveness and cost-utility
timeFrame: 6 months
measure: Barriers and facilitators of CGM use
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Medha N Munshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munshi M, Slyne C, Adam A, Davis D, Michals A, Atakov-Castillo A, Weinger K, Toschi E. Impact of Diabetes Duration on Functional and Clinical Status in Older Adults With Type 1 Diabetes. Diabetes Care. 2022 Mar 1;45(3):754-757. doi: 10.2337/dc21-2000.
citation: Munshi M, Slyne C, Davis D, Michals A, Sifre K, Dewar R, Atakov-Castillo A, Toschi E. Use of Technology in Older Adults with Type 1 Diabetes: Clinical Characteristics and Glycemic Metrics. Diabetes Technol Ther. 2022 Jan;24(1):1-9. doi: 10.1089/dia.2021.0246.
citation: Toschi E, Slyne C, Sifre K, O'Donnell R, Greenberg J, Atakov-Castillo A, Carl S, Munshi M. The Relationship Between CGM-Derived Metrics, A1C, and Risk of Hypoglycemia in Older Adults With Type 1 Diabetes. Diabetes Care. 2020 Oct;43(10):2349-2354. doi: 10.2337/dc20-0016. Epub 2020 May 27.
citation: Toschi E, Munshi MN. Benefits and Challenges of Diabetes Technology Use in Older Adults. Endocrinol Metab Clin North Am. 2020 Mar;49(1):57-67. doi: 10.1016/j.ecl.2019.10.001. Epub 2019 Nov 18.