Type1diabetesNCT05663606
Happy Bob App in 9-13 Year-old Children
A study testing Happy Bob and CGM in people with Type1diabetes, run by Helsinki University Central Hospital.
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… Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Happy Bob and CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes diagnosis more than 6 months ago
- Age 9-13 years
- Prepubertal
- Capability to use Happy Bob -app and continuous glucose monitoring (CGM)
Who cannot join
- Psychiatric diagnosis and other conditions, which in the opinion of the investigator would put the participant at risk during the trial.
About this study
Official title: Glycemic Outcomes and Diabetes Distress in Children With Type 1 Diabetes Aged 9-13 Years Using Happy Bob -Application
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).
Read more
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.
Read the detailed 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.
- Conditions
- Type1diabetes
- Being tested
- Happy Bob, CGM
- Keywords
- Type 1 diabetes, Continuous glucose monitoring, Gamification, Time in Range
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy BobCombination product
Application, which gives stars when subject reachs Time In Range
CGMDevice
Dexcom CGM
| Study group | Role | What they receive |
|---|---|---|
| Happy Bob Arm | Active comparator | Subjects, who are using Happy Bob App in addition to CGM Receives: Combination Product: Happy Bob; Device: CGM |
| Controls | Placebo comparator | Subjects, who are using CGM only Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIR
Change in time in range, 3.9-10 mmol/l (%)
Measured: 6 months
Secondary outcomes (8)
TBR
change in time below range (<3.9 mmol), %
Measured: 6 months
TAR
change in time above range (>10.0 mmol), %
Measured: 6 months
SG
change in mean sensor glucose value (SG) (mmol/l)
Measured: 6 months
SD
change in standard deviation of sensor glucose values (mmol/l)
Measured: 6 months
CV
change in coefficient of variation of sensor glucose values (SG/SDx100),%
Measured: 6 months
Boluses
number of boluses/day (lowest 0, highest not defined)
Measured: 6 months
Diabetes distress
PAID (problem areas in diabetes) score: 0-100, higher score indicates more burden
Measured: 6 months
HbA1c
glycated haemoglobin, mmol/mol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Jun 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Tero Varimo, MD, PhD, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663606
- Sponsor's protocol ID
- OUS-2022-028
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2022
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Outcomes and Diabetes Distress in Children With Type 1 Diabetes Aged 9-13 Years Using Happy Bob -Application
- ClinicalTrials.gov ID
- NCT05663606
- Acronym / sponsor ID
- OUS-2022-028
- Conditions
- Type1diabetes
- Keywords
- Type 1 diabetes, Continuous glucose monitoring, Gamification, Time in Range
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Happy Bob Arm | Active comparator | Combination Product: Happy Bob, Device: CGMSubjects, who are using Happy Bob App in addition to CGM |
| Controls | Placebo comparator | Device: CGMSubjects, who are using CGM only |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Type 1 diabetes diagnosis more than 6 months ago
- Age 9-13 years
- Prepubertal
- Capability to use Happy Bob -app and continuous glucose monitoring (CGM)
Key exclusion criteria (1 listed)
- Psychiatric diagnosis and other conditions, which in the opinion of the investigator would put the participant at risk during the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happy BobApplication, which gives stars when subject reachs Time In Range | Combination product | Happy Bob Arm |
| CGMDexcom CGM | Device | Controls, Happy Bob Arm |
Primary outcome
TIR
Time frame: 6 months
Change in time in range, 3.9-10 mmol/l (%)
8 secondary outcomes
TBR
Time frame: 6 months
TAR
Time frame: 6 months
SG
Time frame: 6 months
SD
Time frame: 6 months
CV
Time frame: 6 months
Boluses
Time frame: 6 months
Diabetes distress
Time frame: 6 months
HbA1c
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Happy Bob and CGM in people with Type1diabetes, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIR (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.