Type 1 DiabetesNCT04259775
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
A study testing Automated Insulin Dose Adjustment in people with Type 1 Diabetes, run by Yale University.
Trial summary
We propose conducting a pilot randomized study to assess the feasibility of using the automated insulin dose adjustment (AIDA) system to assist the parents of children with Type 1 Diabetes to make insulin dose adjustments between visits with their diabetes provider. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Automated Insulin Dose Adjustment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Apr 2023
- 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for at least 1 year ii. Ages 7-21 years iii. Participants 18 years of age must be able to read and provide written consent iv. Participants under 18 years of age must be able to read and provide written assent v. Participants are managed using an insulin pump or multiple daily injections vi. Participant has a CGM or is willing to wear a CGM for the duration of the study
Who cannot join
- Hemoglobin A1c <7.5% or > 10.0% ii. Recent history of more than 1 episode of diabetic ketoacidosis (DKA) in the past 4 months iii. Treatment with glucose lowering drugs other than insulin iv. Females who are pregnant, lactating, or planning to become pregnant in the next 6 months v. Another medical condition that precludes participation in the study.
About this study
We propose conducting a pilot randomized study to assess the feasibility of using the automated insulin dose adjustment (AIDA) system to assist the parents of children with Type 1 Diabetes to make insulin dose adjustments between visits with their diabetes provider. Study results will be used to inform a larger RCT with an anticipated primary outcome of change in HbA1c in patients managed with either standard care (changes in therapy settings effected at regularly scheduled patients visits) or AIDA guided care.
Read the detailed description
Screening \& End of 3-Week Run-in Period (Visit 1, Week 0) : Screening will be conducted by invitation to potentially eligible subjects. The study will be explained and written informed consent will be obtained from parents or patients (when 18 years of age or older) prior to conducting any study-related procedures. After written informed consent and patient assent (when <18 years of age) have been obtained, potential participants will undergo a history and physical exam. Girls of childbearing potential will have a urine pregnancy test performed at the time of the enrollment visit and the need for contraception for the entire duration of the study will be discussed. At this and all other study visits, participants/parents will meet with a diabetes care provider (i.e., a physician, nurse practitioner, or physician assistant) who will carry out a comprehensive review of diabetes management and review blood glucose and ketone records. The treatment regimen will be adjusted as clinically indicated during the initial screening visit and baseline data (including CGM and insulin dose data) will be collected in all participants during the 3-week run-in period of the study; HbA1c levels will be measured at the end of the 3-week baseline period in all eligible participants.
Baseline data obtained at the screening or 3-week baseline visit will include:
- Demographic characteristics, including family income, highest parental education attained, and number of individuals in the home
- 3-week data regarding CGM, insulin dose and Fitbit data
- Anthropometric measures (height, weight, BMI, vital signs) and physical exam
- Current diabetes care practices (frequency of self-monitored blood glucose (SMBG), insulin dosing, review of blood glucose values)
- Medical History: duration of diabetes, comorbidities, past medical history, social history, family history, medications, and allergies
- Additional diabetes history including current/past use of CGM, insulin pump, and other modes of diabetes technology
- Frequency of Emergency Department visits due to decompensated diabetes (i.e., hyperglycemia, ketosis and DKA) over the past 6 months
- Baseline laboratory assessment including lipid panel and urine microalbumin
- Psychosocial Questionnaires will be administered
- Hypoglycemia Fear Survey (parent and child)
- Pittsburgh Sleep Quality Index
- Diabetes Treatment Satisfaction Questionnaire (DTSQ, DTSQc), which includes eight items, six of which form a scale (scored 0-36) in which higher scores indicate greater treatment satisfaction
- Diabetes-specific emotional distress using Problem Areas in Diabetes scale
After collection of all baseline data, eligible participants will be randomized to either the control or intervention group and receive instructions for the study. Participants will also be provided with a FitBit and instructed to wear this for the duration of the study to track activity levels. Participants in the intervention group will be required to upload their diabetes devices to Tidepool each week for the duration of the study. Tidepool is program used at Yale Pediatric Diabetes clinics as the current standard of care for uploading devices (pumps, CGMs, Bluetooth enabled pens) in our clinics and is HIPAA compliant. Participants may contact the Yale Diabetes Team for insulin dose adjustments or the study team at any point during the study if they have a question about the study.
Visit 2 (Week 13) \& Visit 3 (Week 26): At these visits, all participants will meet with a diabetes care provider who will carry out a comprehensive review of diabetes management and review blood glucose and insulin records. Diabetes devices will be downloaded, and glycemic trends and insulin dosing regimens will be reviewed. The treatment regimen will be adjusted as clinically indicated.
After 26 weeks in the study, intervention group parents will be asked to participate in focus groups to discuss the study. These meetings will take place at the Yale Pediatric Diabetes Research Center.
- Conditions
- Type 1 Diabetes
- Being tested
- Automated Insulin Dose Adjustment, Control
- Keywords
- automated insulin dose adjustment, continuous glucose monitor
- 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.
Automated Insulin Dose AdjustmentDevice
The system originally developed at Boston Children's Hospital, obtains CGM, insulin delivery, and activity data, from the cloud each day at approximately 8:00 PM using an Application Program Interface (API) calls to commercial companies (primarily Glooko and Tidepool) that aggregate data from different devices used to manage glucose levels in individuals. A detailed statistical and control analysis (see preliminary data study 1 for algorithm details) of the data are then conducted to determine if a change in therapy is required. If the analysis indicates a change in therapy is required, the patient or parent is notified by text or email directing then to a web portal detailing the change. The patient or parent can accept or modify the recommended change. If a change is made, the AIDA system confirms that the change is correctly implemented into the patient's pump or Bluetooth enabled pen when the patient next uploads the device data to the cloud.
ControlDevice
Standard Care - change in therapy settings effected at regularly scheduled patient visits
| Study group | Role | What they receive |
|---|---|---|
| Automated Insulin Dose Adjustment (AIDA) | Active comparator | Using the AIDA system to assist the parents of children with T1D make insulin dose adjustments Receives: Device: Automated Insulin Dose Adjustment |
| Control | Active comparator | Standard Care - change in therapy settings effected a regularly scheduled patients visits Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients at target range from baseline to 13 week
Based on continuous glucose monitoring. Target range is defined as 70- 180 mg/dL
Measured: 13 weeks
Percent of patients at target range from baseline to 26 weeks
Based on continuous glucose monitoring. Target range is defined as 70- 180 mg/dL
Measured: 26 weeks
Secondary outcomes (12)
Change from baseline in HbA1c
This outcome will determine if there was a change in HbA1c levels from baseline to 13 weeks based on continuous glucose monitoring
Measured: 13 weeks
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
Based on continuous glucose monitoring
Measured: Baseline
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
Based on continuous glucose monitoring
Measured: 13 week
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
Based on continuous glucose monitoring
Measured: 26 week
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
Frequency of nighttime hypoglycemic events
Measured: Baseline
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
Frequency of nighttime hypoglycemic events
Measured: 13 week
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
Frequency of nighttime hypoglycemic events
Measured: 26 week
Percent of the recommendations that are accepted or modified by the family
Percent of the recommendations that are accepted or modified by the family
Measured: 26 week
Hypoglycemia Fear Survey
This will be administered to the child and parent. The survey consists of 23 questions. Questions are answered using a 5 point likert scale ranging from never, rarely, sometimes, often, and always. The administration time is 10 minutes. The higher scores entail greater worry.
Measured: 26 weeks
Pittsburgh Sleep Quality Survey (PSQI)
The survey consists of 10 questions. The Questions relate to usual sleep habits over the last month, including time it takes to fall asleep, usual bedtime, hours of sleep per night, as well as questions about the frequency of sleep issues (not during the past month, less than once per week, once or twice per week, or three or more times per week). Higher scores suggest poorer sleep quality. The administration time is 5 minutes.
Measured: 26 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
This will be administered to the parent and teen. The survey consists of 12-24 questions that are based on a likert scale ranging from 0 to 6. Higher scores entail greater satisfaction. The administration time is 10 minutes.
Measured: 26 weeks
Problem Areas in Diabetes Scale (PAID)
This is a questionnaire with 20 questions scaled from 0 to 4 on a likert scale. Questions involve feelings and emotional distress related to diabetes. Higher scores entail a more serious problem related to diabetes. The Administration time is 5 minutes.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study startSep 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: Needed FDA approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Nally, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259775
- Sponsor's protocol ID
- 2000027002
- Other IDs
- 2K12DK094714-06
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2020
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04259775
- Acronym / sponsor ID
- 2000027002
- Conditions
- Type 1 Diabetes
- Keywords
- automated insulin dose adjustment, continuous glucose monitor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Needed FDA approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 6 Feb 2020 (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.
We propose conducting a pilot randomized study to assess the feasibility of using the automated insulin dose adjustment (AIDA) system to assist the parents of children with Type 1 Diabetes to make insulin dose adjustments between visits with their diabetes provider. Study results will be used to inform a larger RCT with an anticipated primary outcome of change in HbA1c in patients managed with either standard care (changes in therapy settings effected at regularly scheduled patients visits) or AIDA guided care.
Detailed description
Screening \& End of 3-Week Run-in Period (Visit 1, Week 0) : Screening will be conducted by invitation to potentially eligible subjects. The study will be explained and written informed consent will be obtained from parents or patients (when 18 years of age or older) prior to conducting any study-related procedures. After written informed consent and patient assent (when <18 years of age) have been obtained, potential participants will undergo a history and physical exam. Girls of childbearing potential will have a urine pregnancy test performed at the time of the enrollment visit and the need for contraception for the entire duration of the study will be discussed. At this and all other study visits, participants/parents will meet with a diabetes care provider (i.e., a physician, nurse practitioner, or physician assistant) who will carry out a comprehensive review of diabetes management and review blood glucose and ketone records. The treatment regimen will be adjusted as clinically indicated during the initial screening visit and baseline data (including CGM and insulin dose data) will be collected in all participants during the 3-week run-in period of the study; HbA1c levels will be measured at the end of the 3-week baseline period in all eligible participants.
Baseline data obtained at the screening or 3-week baseline visit will include:
- Demographic characteristics, including family income, highest parental education attained, and number of individuals in the home
- 3-week data regarding CGM, insulin dose and Fitbit data
- Anthropometric measures (height, weight, BMI, vital signs) and physical exam
- Current diabetes care practices (frequency of self-monitored blood glucose (SMBG), insulin dosing, review of blood glucose values)
- Medical History: duration of diabetes, comorbidities, past medical history, social history, family history, medications, and allergies
- Additional diabetes history including current/past use of CGM, insulin pump, and other modes of diabetes technology
- Frequency of Emergency Department visits due to decompensated diabetes (i.e., hyperglycemia, ketosis and DKA) over the past 6 months
- Baseline laboratory assessment including lipid panel and urine microalbumin
- Psychosocial Questionnaires will be administered
- Hypoglycemia Fear Survey (parent and child)
- Pittsburgh Sleep Quality Index
- Diabetes Treatment Satisfaction Questionnaire (DTSQ, DTSQc), which includes eight items, six of which form a scale (scored 0-36) in which higher scores indicate greater treatment satisfaction
- Diabetes-specific emotional distress using Problem Areas in Diabetes scale
After collection of all baseline data, eligible participants will be randomized to either the control or intervention group and receive instructions for the study. Participants will also be provided with a FitBit and instructed to wear this for the duration of the study to track activity levels. Participants in the intervention group will be required to upload their diabetes devices to Tidepool each week for the duration of the study. Tidepool is program used at Yale Pediatric Diabetes clinics as the current standard of care for uploading devices (pumps, CGMs, Bluetooth enabled pens) in our clinics and is HIPAA compliant. Participants may contact the Yale Diabetes Team for insulin dose adjustments or the study team at any point during the study if they have a question about the study.
Visit 2 (Week 13) \& Visit 3 (Week 26): At these visits, all participants will meet with a diabetes care provider who will carry out a comprehensive review of diabetes management and review blood glucose and insulin records. Diabetes devices will be downloaded, and glycemic trends and insulin dosing regimens will be reviewed. The treatment regimen will be adjusted as clinically indicated.
After 26 weeks in the study, intervention group parents will be asked to participate in focus groups to discuss the study. These meetings will take place at the Yale Pediatric Diabetes Research Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Insulin Dose Adjustment (AIDA) | Active comparator | Device: Automated Insulin Dose AdjustmentUsing the AIDA system to assist the parents of children with T1D make insulin dose adjustments |
| Control | Active comparator | Device: ControlStandard Care - change in therapy settings effected a regularly scheduled patients visits |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of type 1 diabetes for at least 1 year ii. Ages 7-21 years iii. Participants 18 years of age must be able to read and provide written consent iv. Participants under 18 years of age must be able to read and provide written assent v. Participants are managed using an insulin pump or multiple daily injections vi. Participant has a CGM or is willing to wear a CGM for the duration of the study
Key exclusion criteria (1 listed)
- Hemoglobin A1c <7.5% or > 10.0% ii. Recent history of more than 1 episode of diabetic ketoacidosis (DKA) in the past 4 months iii. Treatment with glucose lowering drugs other than insulin iv. Females who are pregnant, lactating, or planning to become pregnant in the next 6 months v. Another medical condition that precludes participation in the study.
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 |
|---|---|---|
| Automated Insulin Dose AdjustmentThe system originally developed at Boston Children's Hospital, obtains CGM, insulin delivery, and activity data, from the cloud each day at approximately 8:00 PM using an Application Program Interface (API) calls to commercial companies (primarily Glooko and Tidepool) that aggregate data from different devices used to manage glucose levels in individuals. A detailed statistical and control analysis (see preliminary data study 1 for algorithm details) of the data are then conducted to determine if a change in therapy is required. If the analysis indicates a change in therapy is required, the patient or parent is notified by text or email directing then to a web portal detailing the change. The patient or parent can accept or modify the recommended change. If a change is made, the AIDA system confirms that the change is correctly implemented into the patient's pump or Bluetooth enabled pen when the patient next uploads the device data to the cloud. | Device | Automated Insulin Dose Adjustment (AIDA) |
| ControlStandard Care - change in therapy settings effected at regularly scheduled patient visits | Device | Control |
Primary outcome
Percent of patients at target range from baseline to 13 week
Time frame: 13 weeks
Based on continuous glucose monitoring. Target range is defined as 70- 180 mg/dL
Percent of patients at target range from baseline to 26 weeks
Time frame: 26 weeks
Based on continuous glucose monitoring. Target range is defined as 70- 180 mg/dL
12 secondary outcomes
Change from baseline in HbA1c
Time frame: 13 weeks
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
Time frame: Baseline
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
Time frame: 13 week
Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
Time frame: 26 week
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
Time frame: Baseline
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
Time frame: 13 week
Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
Time frame: 26 week
Percent of the recommendations that are accepted or modified by the family
Time frame: 26 week
Hypoglycemia Fear Survey
Time frame: 26 weeks
Pittsburgh Sleep Quality Survey (PSQI)
Time frame: 26 weeks
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 26 weeks
Problem Areas in Diabetes Scale (PAID)
Time frame: 26 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- 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.
Laura Nally, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Automated Insulin Dose Adjustment in people with Type 1 Diabetes, run by Yale University.
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 1 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: withdrawn, as of the sponsor's last update on 27 Apr 2022. 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. 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 withdrawn before enrolling participants, so there are no results.
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?
Percent of patients at target range from baseline to 13 week (time frame: 13 weeks). The study lists 2 primary outcomes in all. 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 27 Apr 2022.