Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734667
• Other study ID #: 35990
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: February 2020

Study information

• Verified date: February 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.

Description:

Synopsis of study protocol

This pilot randomized clinical trial compares newly diagnosed T1D youth who are started on CGM (the intervention group) versus those who are not (the control group). The investigators will examine group differences over a 6-month period (Phase 1) on two sets of outcomes: psychosocial variables and glycemic variables. After the initial comparison of intervention to control across the first six months after diagnosis, the investigators will conduct a longitudinal follow-up (Phase 2) of glycemic and psychosocial variables for an additional 18 months. The CGM system used in this study is the Dexcom G5 System with the Share function (FDA Approved). An IDE was obtained to use this system in a non-adjunctive manner. Participants will complete Phase 1 in six months. Phase 2 includes 3 more assessments conducted every six months until participants are two years post-diagnosis.

Study Procedures

Participants will be recruited at two centers: Stanford University and the Barbara Davis Center for Diabetes, University of Colorado. Participants will be enrolled while inpatient or within 1 month of diagnosis. Once identified, study staff will approach potential participants to explain the study, determine eligibility, and obtain informed consent. Once enrolled in the study, participants will be randomized. Participants will be randomized at a 2:1 ratio, intervention to control. The investigators will also stratify by age group to ensure equal representation of ages across groups. The age groups (in years) are 2-6, 7-11, and 12-17. To ensure safety in the youngest group, recruitment of participants in the age 2-6 years group will not begin until the investigators have at least 2 weeks of non-adjunctive CGM use data in at least 3 participants aged 7-17 years. Data will be reviewed by the DSMB on these 3 participants and if deemed safe by the DSMB, the investigators will start enrolling participants in the youngest age group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

To be eligible for the study, a child must meet the following criteria:

1. Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria

2. Time since diagnosis of no longer than one month

3. Age between 2 and 17 years

4. Parental consent (and assent from the child where applicable) to participate in the study

5. No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.

To be eligible for the study, a parent must meet the following criteria:

1. Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above

2. Age of 18.0 years or older

3. Parent comprehends written English

4. Parent understands the study protocol and signs the informed consent document

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

1. Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).

2. Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol

3. Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study

4. Child is unable to completely avoid acetaminophen for duration of study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• CGM at diagnosis of T1D
Initiation of non-adjunctive CGM use at diagnosis of T1D

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Korey Hood	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Spent in Blood Glucose Range (70-180mg/dL)	Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads. It is calculated using the values for 14 days around the assessment time point.	Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
Primary	Glucose Monitoring Satisfaction Survey (GMSS) - Parent	The GMSS is a validated survey created to measure the level of satisfaction a person with diabetes - type 1 or type 2 - experiences in response to monitoring glucose values. It was validated in people using CGM. Scores range 0 to 5 with higher scores indicating greater satisfaction.	Baseline, 24 months
Primary	Time Spent in Hypoglycemia (< 70 mg/dL)	Time spent in hypoglycemia is calculated using the values for 14 days around the assessment time point.	Collected entire period for 6 months post-baseline; primary endpoint is 14 day period around that 6-month time point
Secondary	Pediatric Quality of Life Inventory	This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living. Scores range from 0 to 100. Higher scores indicate greater quality of life.	Baseline, 24 months
Secondary	Problem Areas in Diabetes Score	Participants in the study report on daily problems with diabetes via this measure. Respondents indicate the degree to which each of the items is currently a problem for them. Score range: 0 to 4, higher scores correspond to more serious problems.	Baseline, 24 months
Secondary	Diabetes Distress Scale	This measure is widely used to capture the psychological distress experienced in relation to diabetes. Parent scale score range: 0-4. Youth scale score range: 1-6. Higher scores indicate greater diabetes-related distress.	Baseline, 24 months
Secondary	Patient Health Questionnaire 9	This is a widely used measure that captures depressive symptoms, and was used to assess health symptoms in parents. Score range: 0-24. Higher scores indicate greater severity of symptoms.	Baseline, 24 months
Secondary	State-Trait Anxiety Inventory	This is a widely used measure of anxiety symptoms, and was used to assess anxiety symptoms in parents. Score range for both state-anxiety is: 20-80. Higher scores indicate greater anxiety.	Baseline, 24 months
Secondary	Pittsburgh Sleep Quality Index	This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants, and was used to assess sleep quality in parents. Score range is: 0-21. Higher scores indicate lower sleep quality.	Baseline, 24 months
Secondary	Hypoglycemic Fear Survey	People with diabetes worry about hypoglycemia, and was used to assess parent's worry about their child. This measure captures those worries. Score range: 0-72. Higher scores indicate greater fear and worry of hypoglycemia.	Baseline, 24 months
Secondary	Hypoglycemic Confidence Questionnaire	Hypoglycemia needs to be managed in various daily situations. This questionnaire captures confidence of the participants in those various situations, and was used to assess parent's confidence. Score range: 8-32. Higher scores indicate greater confidence to manage hypoglycemia.	Baseline, 24 months
Secondary	General and Diabetes-specific Technology Use	This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices. Score range: 5-25. Higher scores indicate more positive attitudes about technology.	Baseline, 24 months
Secondary	Center for Epidemiologic Studies Depression Measure	This is a widely used measure of depression, and was used to assess depression symptoms in youths. Score range: 0-60. Higher scores indicate greater symptoms.	Baseline, 24 months
Secondary	Child Health Utility 9D	Widely used measure of quality of life that is used to generate quality-adjusted life years, and was used to assess health symptoms in youth. Each score scale is 0 to 4, with scores of 3 or 4 denoting more severe problems. The count of participants responding 3 or higher for each parameter are presented.	Baseline, 24 months
Secondary	Hemoglobin A1c	The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes. Collected through a blood sample.	Baseline, 24 months
Secondary	C-peptide	This is a biologic measure of endogenous production and is collected through a blood sample.	Baseline, 24 months