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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Enrollment Rate (%) | up to 9 months | (Number of patients who were shipped devices) / (Number of patients invited to enroll) \* 100 |
| Program Completion Rate (%) | up to 9 months | (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \* 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Age of Participants Who Start Trial (Yrs) | up to 9 months | (Sum of ages of all enrollees) / (Total number of enrollees) |
| Average Age of Participants Who Complete Trial (Yrs) | up to 9 months | (Sum of age of patients who complete) / (Total number who complete) |
| Weekly Average of Estimated Glucose Values (EGV) | up to 10 weeks | (Sum of EGV for a given week) / (Total number of EGV for a given week) |
| Coaching Participation Rate | up to 9 months | (Sum of weekly coaching calls completed) / (Total number of participants\*weeks) |
| Texting With Coaches | up to 9 months | (Sum of all text messages) / (Total number of participants\*days) |
| Change in Medication Dosage (mg/Day; U/Day) | up to 9 months | (dosage of Rx on Day 180) - (dosage of Rx on Day 0) |
Countries
United States
Participant flow
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. | 358 |
| Total | 358 |
Baseline characteristics
| Characteristic | Diabetes Management Educational Program | — |
|---|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 7.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 358 participants | — |
| Sex: Female, Male Female | 184 Participants | — |
| Sex: Female, Male Male | 171 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 358 |
| other Total, other adverse events | 10 / 358 |
| serious Total, serious adverse events | 3 / 358 |
Outcome results
Primary
Program Completion Rate (%)
(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \* 100
Time frame: up to 9 months
Population: Unit of measure, below, should read, percentage of participants completing 10 weeks of CGM, but there is not enough space.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diabetes Management Educational Program | Program Completion Rate (%) | 54 percentage of participants |
Primary
Program Enrollment Rate (%)
(Number of patients who were shipped devices) / (Number of patients invited to enroll) \* 100
Time frame: up to 9 months
Population: Note that the number analyzed is greater than the number of participants (358) because participants are a subset of those who were invited to participate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diabetes Management Educational Program | Program Enrollment Rate (%) | 6.1 percentage of invitees |
Secondary
Average Age of Participants Who Complete Trial (Yrs)
(Sum of age of patients who complete) / (Total number who complete)
Time frame: up to 9 months
Population: One of the 193 participants who completed 10 weeks of CGM use lacked age data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Management Educational Program | Average Age of Participants Who Complete Trial (Yrs) | 70.6 years | Standard Deviation 6.5 |
Secondary
Average Age of Participants Who Start Trial (Yrs)
(Sum of ages of all enrollees) / (Total number of enrollees)
Time frame: up to 9 months
Population: Two of the 358 participants who started the study lacked age data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Management Educational Program | Average Age of Participants Who Start Trial (Yrs) | 71.4 years | Standard Deviation 7.6 |
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 9 months
Population: After starting the study, administrator realized that it would not be able to obtain medication data from participants. There is no data to report for this measure.
Secondary
Coaching Participation Rate
(Sum of weekly coaching calls completed) / (Total number of participants\*weeks)
Time frame: up to 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diabetes Management Educational Program | Coaching Participation Rate | 0.46 calls per participant per week |
Secondary
Texting With Coaches
(Sum of all text messages) / (Total number of participants\*days)
Time frame: up to 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diabetes Management Educational Program | Texting With Coaches | 0.003 text messages per participant per day |
Secondary
Weekly Average of Estimated Glucose Values (EGV)
(Sum of EGV for a given week) / (Total number of EGV for a given week)
Time frame: up to 10 weeks
Population: 358 Participants started the study, but participants dropped out as time passed. By week 10, there were only 193 participants remaining who were providing EGV.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 1 | 153.9 milligrams/deciliter | Standard Deviation 59.7 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 2 | 152.7 milligrams/deciliter | Standard Deviation 57.9 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 3 | 152.3 milligrams/deciliter | Standard Deviation 57.1 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 4 | 152.9 milligrams/deciliter | Standard Deviation 57.4 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 5 | 151.5 milligrams/deciliter | Standard Deviation 54.2 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 6 | 151.1 milligrams/deciliter | Standard Deviation 52.3 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 7 | 149.9 milligrams/deciliter | Standard Deviation 52.3 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 8 | 149.4 milligrams/deciliter | Standard Deviation 54.1 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 9 | 151.0 milligrams/deciliter | Standard Deviation 55.6 |
| Diabetes Management Educational Program | Weekly Average of Estimated Glucose Values (EGV) | Week 10 | 149.6 milligrams/deciliter | Standard Deviation 54.2 |