Clinical trial NCT04259775: Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
Official title: Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: automated insulin dose adjustment
continuous glucose monitor
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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

  1. Hypoglycemia Fear Survey (parent and child)
  2. Pittsburgh Sleep Quality Index
  3. 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
  4. 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.

Eligibility criteria: Inclusion Criteria:

i. 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

Exclusion Criteria:

I. 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.

Primary outcomes:
measure: Percent of patients at target range from baseline to 13 week
timeFrame: 13 weeks
measure: Percent of patients at target range from baseline to 26 weeks
timeFrame: 26 weeks
Secondary outcomes:
measure: Change from baseline in HbA1c
timeFrame: 13 weeks
measure: Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
timeFrame: Baseline
measure: Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
timeFrame: 13 week
measure: Nighttime hypoglycemic defined as the % of time spent <55 mg/dL
timeFrame: 26 week
measure: Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
timeFrame: Baseline
measure: Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
timeFrame: 13 week
measure: Nighttime hypoglycemic defined as the % of time spent under 70 mg/dL
timeFrame: 26 week
measure: Percent of the recommendations that are accepted or modified by the family
timeFrame: 26 week
measure: Hypoglycemia Fear Survey
timeFrame: 26 weeks
measure: Pittsburgh Sleep Quality Survey (PSQI)
timeFrame: 26 weeks
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: 26 weeks
measure: Problem Areas in Diabetes Scale (PAID)
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Laura Nally, MD
role: PRINCIPAL_INVESTIGATOR
References: