Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04646473 |
| Other study ID # |
23559 |
| Secondary ID |
R01DK124428 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 29, 2021 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Trustees of Dartmouth College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study will test an app and web-delivered intervention designed to improve glycemic
control (HbA1c) among young adults with Type 1 diabetes. All participants will receive the
"core" digital intervention, the SweetGoals app, focused on self-monitoring and goal setting.
Efficacy of two independent intervention components (incentives for adherence and web health
coaching) will be tested
Description:
ASSIGNMENT OF PARTICIPANTS:
Interested participants will download the SweetGoals app. Once all screening procedures are
complete, including A1c verification via the mail in test kit, research staff will schedule a
web video meeting to (1) randomize participants and inform them of their intervention
condition assignment; (2)assist participants in setting up their Glooko account and uploading
their devices and orient them to the Glooko data visualization hub; and (3) download the
Glooko mobile app, which may be used by all participants and into which participants without
a Glooko compatible pump will enter carb counts.
INTERVENTION DELIVERY:
All participants will receive the core intervention, the SweetGoals app. Those assigned to
Incentives will receive the app plus incentives for meeting adherence goals. Those assigned
to Coaching will receive web health coaching to increase motivation and skill in
self-management as described below.
DIABETES CARE FOR ALL PARTICIPANTS:
Participants in all conditions will receive ongoing treatment for type 1 diabetes from their
current medical provider. Report of a visit within the past 6 months is a study inclusion
criterion. Study staff will not provide medical care or intervention. All participants will
receive information about recommendations for medical care related to diabetes (e.g.,
quarterly visits and A1c assessment, consistent with Standards of Medical Care in Diabetes).
Informational links will be provided within SweetGoals for various online resources
addressing T1D educational topics.
CORE INTERVENTION FOR ALL PARTICIPANTS: SWEETGOALS APP
All participants will receive the SweetGoals app, an automated intervention that sets weekly
self-management goals and provides weekly feedback. The SweetGoals app will be implemented
and delivered using the MobileCoach app platform, which runs on both Android and iOS systems.
The SweetGoals app sends weekly reminders to upload devices, retrieves device data via the
Glooko API, applies decision rules to evaluate daily and weekly goals, and sends weekly
feedback messages about goal adherence and encouragement about adherence in the upcoming
week.
Diabetes Self-Management Goals. Glooko stores multiple variables that are used to evaluate
the glucose monitoring and mealtime goals. Across both glucose monitoring and mealtime target
behaviors, we use a similar structure to the goals to promote ease of remembering the goals
and communication with participants. Specifically, regardless of the devices used or the
target (glucose monitoring or mealtime behaviors) there is a daily adherence goal, and there
is a weekly goal of meeting the daily goal on >5 days each week. These weekly goals were
selected to promote high consistency in mealtime glucose monitoring and carb counting. Each
week, participants will be asked to set personal goals for the next week for the number of
days they think they can meet each daily goal. Each week they will receive a message stating
the number of days on which they met each goal, how that compared to their personal goal, and
whether they met the ultimate weekly goal (met daily goal >5 days per week).
Glucose monitoring goals. Each participant will receive a device-specific (glucometer vs.
CGM) daily goal based on the device they use to monitoring their glucose levels, and the
ultimate weekly goal for all participants is to meet the daily goal on at least 5 days per
week. For participants who use a glucometer only, the daily self-monitoring of blood glucose
(SMBG) goal is >5 checks, each >2 hours from another check. For participants who use CGM, the
CGM wear time goal is 80% of expected values each day. Expected values per day are based on
the device-specific check frequency (e.g., every 5 mins for Dexcom G6). We selected this
cutoff to reflect clinically necessary glucose monitoring frequency, but also allow for
legitimate disconnect time (sports, leisure activities) and sensor changes.
Mealtime goals. Each participant will receive daily goals specific to their insulin delivery
method (pump vs. MDI). Participants will be asked to check their glucose before they eat (if
they use a glucometer only, not CGM). Participants who use a Glooko compatible pump will only
need to use their pump to document the mealtime goals. If they use a pump+glucometer
combination that requires manual entry of the glucose value into the pump, they must complete
the glucose check and that manual entry no longer than 30 minutes before the carb entry to
receive credit for meeting the mealtime goal. If they use a pump+CGM or other meter that
transfers the glucose value to the pump without manual entry, no manual entry is necessary.
If they use MDI (no insulin pump), they will use the Food event screen to enter their carb
counts in the Glooko smartphone app.
When each participant's Glooko data are retrieved, our algorithm evaluates whether or not
there is a valid glucose value within 30 minutes prior to each carb entry. The daily mealtime
target is 3 paired glucose level/carb count values.
INCENTIVE COMPONENT
In addition to using the SweetGoals app, participants assigned to Incentives will also
receive incentives for meeting goals. Incentives to improve adherence to glucose monitoring
and mealtime behaviors that support appropriate insulin bolusing are paid weekly from weeks
1-11, then fade in frequency from weeks 12-25, a procedure used to promote long lasting
improvements in adherence and A1c. In the fading phase, incentives are paid at increasing
time intervals (i.e., 2,3,4 then 5-week delays; paid at weeks 13, 16, 20, 25).
For meeting daily and weekly goals, participants can earn the following incentives: (1) $1
for each day meeting glucose monitoring goal. (maximum=$7 per week); (2) $5 per week bonus
for meeting the glucose monitoring goal 6 or 7 days to promote consistent weekly glucose
monitoring. (maximum=$5 per week) (3) $1 for every day with >3 properly timed glucose
value/carb entry pairs (maximum=$7 per week); (4) $5 per week bonus for meeting the mealtime
goal 6 or 7 days to promote consistent weekly glucose checking and carb counting at mealtime.
(maximum=$5 per week). Total earnings possible each week are $24 (~$3.50 per day). The
maximum earnings for all goals are $600 across 25 weeks. Research staff will load earned
incentives on reloadable prepaid MasterCards.
WEB HEALTH COACHING COMPONENT:
Participants assigned to coaching will also receive 15 Web Health Coaching sessions by a
bachelors-level health coach. These coaching sessions are designed to promote effective
self-management of diabetes. Coaching sessions are held weekly from weeks 1-11, then fade
over the second half of the intervention with 4 sessions held during weeks 12-25 (weeks 13,
16, 20, and 25). Sessions 1-7 are 30 minutes each, as new material is introduced and
practiced. Sessions 8-15 are 15 minutes each, as problem solving skills are practiced and
applied to new challenges identified by participants. Coaching will be completed using Zoom,
an online HIPAA compliant web conference system.
