Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05663606 |
| Other study ID # |
OUS-2022-028 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
September 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Helsinki University Central Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to evaluate the effectiveness of the Happy Bob -application on
glycemic control in children aged 9-13 years with type 1 diabetes. Additionally,
investigators evaluate the perceived burden on the diabetes treatment to families during the
Happy Bob use, compared to conventional treatment (diabetes distress).
This is a prospective, randomized, controlled study where primary endpoint is the change in
time-in-range (TIR, 3.9-10 mmol/l) after Happy Bob application initiation. Secondary
endpoints are HbA1c, time below range (TBR, <3.9 mmol/l), time above range (TAR, >10 mmol/l),
mean sensor glucose (SG), standard deviation of SG, coefficient of variation (CV, SD/SGx100
(%)), number of boluses and diabetes distress evaluated by PAID (Problem Areas In Diabetes
for parents and children/youth). A sample size of 40 subjects (20 in each groups, and assumed
drop-out rate of 10%) would provide the trial with 80% power and type 1 error rate of 0.05
with the following assumption: 7% higher TIR during Happy Bob -use compared to conventional
treatment with continuous glucose monitoring (CGM), with a standard deviation of 7.5% (based
on Happy Bob marketing study).
The inclusion criteria are 1) Type 1 diabetes diagnosis more than 6 months ago 2) Age 9-13
years and prepubertal 3) capability to use Happy Bob -app and continuous glucose monitoring
(CGM). The exclusion criteria are psychiatric diagnosis and other conditions, which in the
opinion of the investigator would put the participant at risk during the trial.
The study includes 6 months study time with 2 standard outpatient clinic visits.
Description:
The study will be conducted at pediatric diabetes outpatient clinics of Helsinki University
Hospital (New Children's Hospital, Jorvi Hospital, Lohja Hospital, Porvoo Hospital and
Raasepori Hospital).
The study protocol is explained to the participants (9-13 -year-old children) and their
guardian(s). Informed consent from participants' caregivers and participants will be taken by
investigators, clinicians or diabetes nurses. The investigator or his/her representative will
explain the nature of the study to the patient and parents, and answer all questions
regarding the study. Prior to any study-related screening procedures, the informed consent
statement will be reviewed and signed and dated by the participant's caregiver.
The participants are using their usual diabetes treatment (multiple daily injections, MDI, or
continuous subcutaneous insulin infusion, CSII) with Dexcom™ G6 (Dexcom Inc., San Diego, CA)
CGM during the study period and will get instructions for insulin treatment from their
diabetes nurses/doctors as usual. Study group will also use Happy Bob application, which
takes data from Dexcom CGM system, and gives a user a star, whenever he/she is within target
area, measured every five minutes. The more stars patients get, the better the score is.
Happy Bob is not a medical device, and it does not give any instructions on how to dose
insulin. The use of CGM is familiar to subjects and their families, since every patient is
already using some CGM before the study. If Dexcom CGM is not the CGM device patients uses
normally, the instructions for the use is given by study nurses either remotely (video
appointment) or during outpatient clinic group visit.
The instruction for the Happy Bob use is given by study nurse in groups, either remotely
(video appointment) or in outpatient clinic group visit.
The used CGM is Dexcom G6 sensor, which is integrated to Happy Bob -app. It measures the
glucose level in the subcutaneous tissue. The CGM sensor connects to a transmitter that sends
the glucose data to patients phone (Dexcom app) and receiver device. The sensor is worn for
10 days and then replaced with a new one by the patients' caregivers. The CGM data are
collected from Glooko® Therapy management software, which is in clinical use at Helsinki
University Hospital. The data from CGM is downloaded either by caregivers or diabetes nurse
at diabetes clinic.
Glycated haemoglobin (HbA1c, mmol/mol) (Afinion2™, Abbott) is measured by a diabetes nurse
from fingertip as point of care test. The Diabetes Distress is evaluated by a standardized
questionnaire (PAID) in run-in phase and at 6 months visit.
The study includes a starting visit, during which Happy Bob and Dexcom G6 CGM is started and
patient's normal outpatient clinic visits in 3 and 6 months.
