Technological Advances in Glucose Management in Older Adults

NCT03078491 | Completed DMC

• 1 other identifier: CHS #2016-29
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus; Older Adults; Hypoglycemia

Keywords

type 1 diabetes; geriatrics; older adults; technology; CGM; clinical decision support; hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Change in duration of hypoglycemia

  Minutes per day CGM \< 70 mg/dL assessed over 2 weeks CGM use (blinded in the control arm; unblinded in the treatment arm)

  change of duration of hypoglycemia(minutes/day) from baseline to 6 months between intervention and control groups

Secondary Outcomes (6)

• Fasting and bedtime CGM glucose values per day

  change in glucose values(mg/dl) from baseline to 6 months between intervention and control groups

• Severe biochemical hypoglycemia

  change in severe biochemical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups

• Severe clinical hypoglycemia

  change in severe clinical hypoglycemia (episodes per day) from baseline to 6 months between intervention and control groups

• Hemoglobin A1C

  Change in A1C (%) from baseline to 6 months between intervention and control groups

• Cost-effectiveness and cost-utility

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will use eCGM (CGM with Diabetes Management Platform(DMP)) and an activity meter. The DMP will be pre-loaded with geriatric-specific education material, weblink to online education and surveys. 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 DMP can also be configured to route the insulin regimen change approved by the study physician to the designated care providers of the patient. Blue-tooth unabled insulin pens will also provide additional data to verify if the patient is taking recommended insulin doses.

Other: eCGM (enhanced CGM)

Attention Control

NO INTERVENTION

The attention control group will receive an android tablet pre-loaded with activity monitor devices, education material, and weblink to online education and surveys. However, the data will not be analyzed by CDS. An independent physician and a study staff member- only caring for the control group subjects will review the insulin and glucose data at in-person and remote study visits and make appropriate dosing adjustments based on self monitoring glucose levels

Interventions

eCGM (enhanced CGM) OTHER

Glucose (CGM and Bluetooth BG meter), insulin (pump or Bluetooth insulin pen) and activity data will be automatically uploaded via the subjects' tablet computers, and analyzed by the CDS. The CDS will, if indicated generate adjustable insulin dosing recommendations that will compensate for different insulin requirements following high vs low activity days. The recommendations of the CDS will be used by the clinical team in their therapeutic decision-making about insulin dosing adjustments at the scheduled study follow up visits and the remote visits between these in-person visits. In addition, study staff will provide recommendations regarding hypoglycemic warning symptoms, causes, and appropriateness of treatment.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Beth Israel Deaconess Medical Center: collaborator
• Boston Children's Hospital: collaborator
• RTI International: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

• 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.

  PMID: 35076712 DERIVED

• 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.

  PMID: 34524033 DERIVED

• 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.

  PMID: 32461211 DERIVED

• 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.

  PMID: 31980121 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Medha N Munshi, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 13, 2017
• Study Start: March 30, 2017
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)