N/A
N=52
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03252964 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Program Enrollment Rate (%) — 14 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous Glucose Monitor (CGM) (Device); Activity Tracker (Device); Coaching (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Savvysherpa, Inc.
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Program Enrollment Rate (%) |
14 | — |
| PRIMARY Program Completion Rate (%) |
38 | — |
| SECONDARY Change in A1c Measurement (%) |
— | — |
| SECONDARY Weekly Average of Estimated Glucose Values (EGV) (Average) |
— | — |
| SECONDARY Change in Medication Dosage (mg/Day; U/Day) |
— | — |
| SECONDARY Average Age of Participants Who Start Trial (Yrs) |
— | — |
| SECONDARY Average Age of Participants Who Complete Trial (Yrs) |
— | — |
| SECONDARY Race of Participants Who Start the Trial (n) |
— | — |
| SECONDARY Ethnicity of Participants Who Start the Trial (n) |
— | — |
| SECONDARY Texting With Coaches (Daily Average of Text Messages) |
— | — |
| SECONDARY Coaching Participation Rate |
— | — |
Summary
This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.
Eligibility Criteria
Inclusion Criteria
- Be diagnosed with type 2 diabetes
- Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin
- Be able to read and understand English
- Have access to a telephone
- Have a Medicare health plan
Exclusion Criteria
- Pregnant
- Blind
- Deaf
- Currently receiving chemotherapy or radiation therapy to treat cancer
- Addicted to any drugs (including alcohol, painkillers, hallucinogens, or others)
- Critically ill
- Diagnosed with or experiencing:
- Kidney disease stages 4 and 5
- End stage renal disease
- Severe liver disease
- Dementia
- Schizophrenia
- Bipolar disorder
- Autism
- An intellectual or learning disability
- Arrhythmias other than atrial fibrillation
- Congestive heart failure
- Has had a:
- Myocardial infarction within the last 6 months
- Stroke within the last 6 months
- Stroke that resulted in significant disability (e.g., unable to write clearly or walk)
Data sourced from ClinicalTrials.gov (NCT03252964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.