N/A
N=358
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)
Type2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03290768 ↗Enrolled (actual)
358
Serious AEs
0.8%
Results posted
Jul 2019
Primary outcome: Primary: Program Enrollment Rate (%) — 6.1 percentage of invitees
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
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Program Enrollment Rate (%) |
6.1 | — |
| PRIMARY Program Completion Rate (%) |
54 | — |
| SECONDARY Weekly Average of Estimated Glucose Values (EGV) |
153.9; 152.7; 152.3; 152.9; 151.5; 151.1 | — |
| SECONDARY Change in Medication Dosage (mg/Day; U/Day) |
— | — |
| SECONDARY Average Age of Participants Who Start Trial (Yrs) |
71.4 | — |
| SECONDARY Average Age of Participants Who Complete Trial (Yrs) |
70.6 | — |
| SECONDARY Texting With Coaches |
0.003 | — |
| SECONDARY Coaching Participation Rate |
0.46 | — |
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
- Be able to read and understand English
- Have access to a telephone
- Have a Medicare Advantage health plan through Senior Dimensions
Exclusion Criteria
- Pregnant
- Blind
- Deaf
- Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)
- Misusing 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 (NCT03290768). 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.