Insulin Treated Type 2 Diabetes MellitusNCT04158921
Control:Diabetes Pilot Study I
A study of Insulin Treated Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin Treated Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to 20 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of Type 1 Diabetes or Type 2 Diabetes
- Treatment with multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII)
- Baseline HbA1c between 7% and 10.5% (as reported by the participant) and/or self- reported frequency of symptomatic hypoglycemia ≥ 3 times / week
- Ownership of a smartphone running either Android or iOS operating system with an active data plan
Who cannot join
- Using a closed loop insulin delivery system (Medtronic 670G or OpenAPS)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes
This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. This study will enroll approximately 70 individuals with insulin-treated diabetes mellitus. The study will include two online surveys (baseline and exit), one study initiation phone call, and will also collect data entered by the users into the mobile app.
Read the detailed description
The objectives of this study are to:
- Test the hypothesis that patients with diabetes mellitus treated with insulin and elevated blood glucose will achieve better glycemic control after using the Control:Diabetes mobile app.
- Test the hypothesis that patients with diabetes mellitus treated with insulin and frequent hypoglycemia will achieve lower frequency of hypoglycemia after using the Control:Diabetes mobile app.
- Being tested
- Control:Diabetes mobile app
- Keywords
- Diabetes Mellitus, Insulin Therapy, Glycemic Control, Hyperglycemia, Hypoglycemia, Health Education, Self-Management, Lifestyle
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Hyperglycemia, Hypoglycemia, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control:Diabetes mobile appOther
The Control:Diabetes app will encourage patients to: a) predict their blood glucose level at a particular time point in the future (e.g. the next morning); then b) enter their actual blood glucose levels when that time (the next morning) comes; and c) enter reasons for the discrepancy between prediction and reality, if the prediction was significantly (e.g. > 20%) different from the actual measurement. We hypothesize that by repeatedly encouraging disassembly of blood glucose changes into individual reasons (cognitive task analysis) while providing an incentive in the form of being able to more accurately predict blood glucose levels (operant conditioning), the app will prompt the patient to learn how various internal and environmental factors affect their blood glucose. They will then be able to adjust their behavior and medications to improve their blood glucose control.
| Study group | Role | What they receive |
|---|---|---|
| The Control:Diabetes mobile app for Diabetes self-management. | Other | This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app. Receives: Other: Control:Diabetes mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in blood glucose.
As recorded by the patient in the app.
Measured: Measured between the first two weeks and the last two weeks of the study.
Secondary outcomes (1)
The change in the number of hypoglycemic episodes.
Number of low blood sugar episodes as reported in the study surveys.
Measured: Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start7 Nov 2019
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Treated Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Turchin, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158921
- Sponsor's protocol ID
- controldiabetes01
- Status last verified
- Jun 2023
- First submitted
- 7 Nov 2019
- Last updated
- 22 Jun 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT04158921
- Acronym / sponsor ID
- controldiabetes01
- Keywords
- Diabetes Mellitus, Insulin Therapy, Glycemic Control, Hyperglycemia, Hypoglycemia, Health Education, Self-Management, Lifestyle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 12 Nov 2019 (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.
This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. This study will enroll approximately 70 individuals with insulin-treated diabetes mellitus. The study will include two online surveys (baseline and exit), one study initiation phone call, and will also collect data entered by the users into the mobile app.
Detailed description
The objectives of this study are to:
- Test the hypothesis that patients with diabetes mellitus treated with insulin and elevated blood glucose will achieve better glycemic control after using the Control:Diabetes mobile app.
- Test the hypothesis that patients with diabetes mellitus treated with insulin and frequent hypoglycemia will achieve lower frequency of hypoglycemia after using the Control:Diabetes mobile app.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Control:Diabetes mobile app for Diabetes self-management. | Other | Other: Control:Diabetes mobile appThis is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosis of Type 1 Diabetes or Type 2 Diabetes
- Treatment with multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII)
- Baseline HbA1c between 7% and 10.5% (as reported by the participant) and/or self- reported frequency of symptomatic hypoglycemia ≥ 3 times / week
- Ownership of a smartphone running either Android or iOS operating system with an active data plan
Key exclusion criteria (1 listed)
- Using a closed loop insulin delivery system (Medtronic 670G or OpenAPS)
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 |
|---|---|---|
| Control:Diabetes mobile appThe Control:Diabetes app will encourage patients to: a) predict their blood glucose level at a particular time point in the future (e.g. the next morning); then b) enter their actual blood glucose levels when that time (the next morning) comes; and c) enter reasons for the discrepancy between prediction and reality, if the prediction was significantly (e.g. > 20%) different from the actual measurement. We hypothesize that by repeatedly encouraging disassembly of blood glucose changes into individual reasons (cognitive task analysis) while providing an incentive in the form of being able to more accurately predict blood glucose levels (operant conditioning), the app will prompt the patient to learn how various internal and environmental factors affect their blood glucose. They will then be able to adjust their behavior and medications to improve their blood glucose control. | Other | The Control:Diabetes mobile app for Diabetes self-management. |
Primary outcome
The mean change in blood glucose.
Time frame: Measured between the first two weeks and the last two weeks of the study.
As recorded by the patient in the app.
1 secondary outcome
The change in the number of hypoglycemic episodes.
Time frame: Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Insulin Treated Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Brigham and Women's Hospital at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was stopped early (reason given: Lack of funding). 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?
The mean change in blood glucose. (time frame: Measured between the first two weeks and the last two weeks of the study.). 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 22 Jun 2023.