Type2 Diabetes
Conditions
Brief 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.
Interventions
DEVICEContinuous Glucose Monitor (CGM)
Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
DEVICEActivity Tracker
Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.
BEHAVIORALCoaching
Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.
Sponsors
Savvysherpa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Enrollment Rate (%) | up to three months | (Number of patients who signed a consent form)/(Number of patients invited to enroll) |
| Program Completion Rate (%) | up to six months | (Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Dosage (mg/Day; U/Day) | up to six months | (dosage of Rx on Day 180)-(dosage of Rx on Day 0) |
| Average Age of Participants Who Start Trial (Yrs) | up to three months | (Sum of ages of all enrollees)/(Total number of enrollees) |
| Average Age of Participants Who Complete Trial (Yrs) | up to six months | (Sum of age of patients who complete)/(Total number who complete) |
| Change in A1c Measurement (%) | Day 0 and Day 180 | (Final A1c measure)-(Initial A1c measure) |
| Ethnicity of Participants Who Start the Trial (n) | up to three months | Sum of Hispanic or Latino and Sum of Not Hispanic or Latino |
| Texting With Coaches (Daily Average of Text Messages) | up to six months | (Sum of all text messages)/(Total number of days) |
| Coaching Participation Rate | up to six months | (Sum of weekly coaching calls completed)/(Total number of weeks) |
| Race of Participants Who Start the Trial (n) | up to three months | Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White |
| Weekly Average of Estimated Glucose Values (EGV) (Average) | up to six months | (Sum of EGV for one week)/(Total number of EGV) |
Countries
United States
Participant flow
Recruitment details
364 candidates were contacted. Of those, 52 enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Diabetes Management Educational Program Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging. | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Diabetes Management Educational Program | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 44 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 2 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Program Completion Rate (%)
(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)
Time frame: up to six months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diabetes Management Educational Program | Program Completion Rate (%) | 38 Percentage of participants |
Primary
Program Enrollment Rate (%)
(Number of patients who signed a consent form)/(Number of patients invited to enroll)
Time frame: up to three months
Population: 52 participants enrolled in the study. Hence, 52 participants analyzed. However, enrollment rate is the number of participants enrolled (52) divided by the number of candidates contacted (364). This explains why the Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diabetes Management Educational Program | Program Enrollment Rate (%) | 14 Percentage of participants |
Secondary
Average Age of Participants Who Complete Trial (Yrs)
(Sum of age of patients who complete)/(Total number who complete)
Time frame: up to six months
Population: Lack of study resources to collect sufficient data on outcome variable.
Secondary
Average Age of Participants Who Start Trial (Yrs)
(Sum of ages of all enrollees)/(Total number of enrollees)
Time frame: up to three months
Population: Lack of study resources to collect adequate information on this variable.
Secondary
Change in A1c Measurement (%)
(Final A1c measure)-(Initial A1c measure)
Time frame: Day 0 and Day 180
Population: Lack of study resources to collect sufficient information on this variable.
Secondary
Change in Medication Dosage (mg/Day; U/Day)
(dosage of Rx on Day 180)-(dosage of Rx on Day 0)
Time frame: up to six months
Population: Lack of study resources to collect adequate information on this variable.
Secondary
Coaching Participation Rate
(Sum of weekly coaching calls completed)/(Total number of weeks)
Time frame: up to six months
Population: Lack of study resources to collect sufficient data on outcome variable.
Secondary
Ethnicity of Participants Who Start the Trial (n)
Sum of Hispanic or Latino and Sum of Not Hispanic or Latino
Time frame: up to three months
Population: Lack of study resources to collect sufficient data on outcome variable.
Secondary
Race of Participants Who Start the Trial (n)
Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White
Time frame: up to three months
Population: Lack of study resources to collect sufficient data on outcome variable.
Secondary
Texting With Coaches (Daily Average of Text Messages)
(Sum of all text messages)/(Total number of days)
Time frame: up to six months
Population: Lack of study resources to collect sufficient data on outcome variable.
Secondary
Weekly Average of Estimated Glucose Values (EGV) (Average)
(Sum of EGV for one week)/(Total number of EGV)
Time frame: up to six months
Population: Lack of study resources to collect sufficient information on this variable.