isCGM With Education and Feedback for Non-Insulin Dependent Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— iCUDE  

Official title:

Intermittently Scanned CGM Versus Usual Care With Diabetes Education and Feedback, in Adults With Non-Insulin Dependent Type 2 Diabetes (iCUDE): A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319496
• Other study ID #: Pro00119503
• Status: Completed
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Glycemic control is an important for adults with diabetes. Self-monitoring of glucose can help adults with type 2 diabetes (T2DM) meet their glucose targets. Continuous glucose monitoring (CGM), an alternative to traditional capillary (finger-stick) blood glucose, uses a wearable sensor that continuously measures glucose levels under the skin. With intermittently scanned CGM (isCGM), patients scanning the sensor to obtain readings. isCGM is painless, provides information on glucose trends, and has improves patient satisfaction.

Most adults with diabetes are not on insulin. Yet, the effectiveness of CGM is not well studied in this population. In this randomized trial, we are looking for adults with type 2 diabetes, who need further blood glucose lowering (HbA1c > 7.0%), who are not yet on insulin. Participants randomized to the treatment group (50%) will receive isCGM with individual coaching; those in the the enhanced usual care group (50%) will receive diabetes coaching only. The intervention will feature three FreeStyle Libre 2 (Abbott Laboratories, IL) sensors (6 weeks), and is intended to be affordable and applicable to a wide range of adults with diabetes under real world conditions.

Description:

Objective: To evaluate the effectiveness of intermittently scanned continuous glucose monitoring (isCGM) with education and feedback on glycemic control at 12 weeks, in adults with type 2 diabetes and uncontrolled HbA1c (> 7.0%) not on insulin therapy.

Background: Continuous glucose monitoring (CGM) has been shown to reduce hypoglycemia in adults on insulin. The effectiveness of CGM in adults with type 2 diabetes not on insulin therapy has not been well studied. We hypothesize that isCGM linked to structured education - specifically one-on-one review and feedback of glucose values with a diabetes educator - can improve HbA1c via a combination of improved lifestyle choices and accelerated medication intensification, in adults with earlier T2DM. To test this hypothesis, we propose a randomized controlled trial of isCGM + structured education, versus enhanced usual care with structured education only.

Methods: Open-label, 12-week, single-center randomized controlled trial. Included adults will be randomized 1:1 to intervention or enhanced usual care. Intervention participants will receive three FreeStyle Libre 2 (Abbott Laboratories, IL) isCGM sensors to be applied over weeks 1-6. Diabetes education and coaching will be provided at the beginning and end of the sensor period. The control group will receive diabetes education and coaching during weeks 1-2 and 5-6, but not the isCGM sensors. The primary outcome (HbA1c change from baseline) will be measured by venous blood draw at 12 weeks. Participants will be asked to complete patient-reported outcome instruments for secondary outcomes, e.g.: diabetes self-empowerment, diet, and physical activity - at baseline, 6 weeks, and 12 weeks.

Significance: This trial will examine the effectiveness of scheduled, intermittent use of isCGM sensors for type 2 diabetes, when combined with education and feedback. The intervention is designed to be affordable and applicable to a wide range of adults with diabetes, and may have significant implications for the use of isCGM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 12, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >= 18 years with type 2 diabetes.

• HbA1c > 7.0% within the last 6 months.

• Non-insulin therapy.

• Able to attend two in-person study visits.

• English-speaking.

• Community-dwelling

• In possession of a cell phone capable of accessing the internet and receiving FreeStyle Libre 2 sensor readings

• Has a primary care provider who has been in contact with the patient for diabetes in the last 12 months.

Exclusion Criteria:

• Type 1 diabetes or diabetes clearly identified as having monogenetic etiology (e.g.:

MODY).

• Steroid-induced diabetes if steroid use is on-going or most recently taken within the last 3 months.

• Pregnancy; plans to become pregnant within 6 months; breast-feeding.

• Any use of insulin in the previous year.

• Current or previous use of isCGM or rtCGM within the last 6 months.

• Cognitive dysfunction (SPMSQ score >= 5).

• Symptoms of acute metabolic decompensation (extreme thirst, high urinary output, and weight loss, accompanied by acute fatigue or dyspnea).

• Any terminal condition that would limit life expectancy to < 1 year.

• Inability to use isCGM (e.g.: afraid of the device).

• Inability to be reached by telephone.

• Concurrent participation in a different diabetes-related trial.

• Has not already received two doses of a Health Canada-approved vaccine against SARS-CoV-2.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Intermittently scanned continuous glucose monitor (isCGM)
A wearable sensor the size of 2 stacked quarters, that allows individuals to "scan" their glucose levels on demand. No fingerstick is required. The device measure interstitial glucose through a filament that is inserted under the skin. The application process is painless, and each sensor lasts 90 days. Sensors can be scanned with certain smart phones. This device is marketed as the FreeStyle Libre 2 glucometer (Abbott Laboratories, IL).

Behavioral:
• Education and coaching
Two encounters with a certified diabetes educator, who will assess lifestyle and medications, and provide individualized advice on diet, physical activity, and medication changes to improve glycemic control.

Locations

Country	Name	City	State
Canada	University of Alberta Hospital / Kaye Edmonton Clinic	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Epidemiology Coordinating and Research Centre, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c assessed by venous blood draw, compared to baseline.	12 weeks
Secondary	Diabetes treatment satisfaction	Difference in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score from baseline (DTSQs scores range 0-36, higher indicating better treatment satisfaction); DTSQc "change" score at 6 weeks.	6 weeks and 12 weeks
Secondary	Diabetes self-care empowerment	Change in Diabetes Empowerment Scale - Short Form (DES-SF) score from baseline. DES-SF score ranges 1-5, higher scores indicating greater self-care empowerment.	6 weeks and 12 weeks
Secondary	Diabetes-related distress	Change in Problem Areas in Diabetes Questionnaire (PAID) score from baseline. PAID score ranges 0-100, a score above 40 indicates severe diabetes distress.	6 weeks and 12 weeks
Secondary	Healthy diet	Change in UK Diabetes and Diet Questionnaire (UKDDQ) score from baseline. UKDDQ score ranges 0-5 with higher scores indicating more healthy dietary choices.	6 weeks and 12 weeks
Secondary	Physical activity	Change in International Physical Activity Questionnaire (IPAQ) short form score. IPAQ score estimates total metabolic equivalent-minutes per week, with higher scores indicating more a more physically active individual.	6 weeks and 12 weeks
Secondary	Health-related quality of life	Change in Euroqol EQ-5D-5L health utility score from baseline. EQ-5D scores range from 0-100, with 100 indicating a state of perfect health.	6 weeks and 12 weeks
Secondary	Emergency department visits	Number of emergency department visits during the 12-week trial period.	12 weeks
Secondary	Hospital admissions	Number of hospital admissions during the 12-week trial period.	12 weeks