Retrospective and Prospective Study on Professional Continuous Glucose Monitoring in Insulin-treated Type 2 Diabetes

NCT04141111 | Completed DMC FDA Device

• 1 other identifier: 639/2015
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

In people with type 2 diabetes (T2D) without adequate glycemic control for an extended period of time, continuous glucose monitoring (CGM) can provide detailed information about daily glycemic profile facilitating therapeutic adjustments decision which can contribute to an improvement of glycemic control and overall health status. The ADJUST study aims to evaluate the impact of CGM systems' use on clinical decision and glycemic control of people with badly controlled T2D, already under insulin therapy.

Conditions

Diabetes Mellitus, Type 2

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

• Glycemic control

  Evaluated by glycated haemoglobin (A1c). A1c is expressed as %, in relation to native haemoglobin. This is a validated clinical laboratory parameter.

  -12 months to 12 months, in relation to study initiation

• Glycemic control

  Evaluated by TIR (time-in-range), deduced through CGM-generated analysis as the time spent between 70 and 140 mg/dl glucose. TIR is expressed as % of time duration.

  Study initiation and 4, 8 and 12 months

Secondary Outcomes (3)

• Health status

  Study initiation and 12 months

• Treatment satisfaction

  Study initiation and 12 months

• Therapeutic changes

  During the previous year, and at 4, 8 and 12 months

Study Arms (1)

CGM intervention

EXPERIMENTAL

Underwent intervention defined by the intermittent use of a continuous glucose monitoring (CGM) device.

Device: Continuous Glucose Monitoring (CGM)

Interventions

Continuous Glucose Monitoring (CGM) DEVICE

On each visit (baseline, 4, 8, and 12 months), participants received an iPro2 CGM device (MiniMed Medtronic), placed according to the manufacturer's standard procedure. The iPro2 was used each time for 7-days. During this period, patients were asked to perform 4 SMBG measurements daily for calibration (fasting, lunch, dinner, and before bed). Patients received a diary to register food intake, physical activity and medication, SMBG values, and any diabetes-related event (extra consultations, phone calls, etc) in the previous 4 months. Each time, CGM data was interpreted by an expert clinician, and a report was delivered, within one week, to the respective healthcare team. This report was discussed together by the patient and one member of the healthcare team, either in consultation or by phone, agreeing on any necessary therapeutic changes. If necessary, extra consultations for nutrition, nursing, or education, were scheduled, to address specific needs identified during rCGM review.

CGM intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to enrolment.
• Male or female, aged between 18-65 years old.
• Type 2 Diabetes Mellitus for more than 12 months, on insulin, on a stable dose for 60 days prior to screening.
• Available clinical records for the past 12 months, regarding medical treatment for diabetes and A1c evaluations.
• A1c \>7.5 % in the 60 days prior to screening.
• Discrepancies between A1c and glycaemic levels (the log book not reflecting the A1c result) that justify the clinical decision of pCGM future use.
• Decision to use Carelink iPro must precede enrollment.
• Ability to adhere to protocol requirements.

You may not qualify if:

• Gestational Diabetes.
• Pregnant or planning to become pregnant during the course of the study.
• Continuous Glucose Monitoring use by any device or manufacturer in the year prior to screening.
• Serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
• Inability to comply with study requirements.

Sponsors & Collaborators

• Associacao Protectora dos Diabeticos de Portugal: lead
• Medtronic: collaborator

Study Sites (1)

APDP

Lisbon, 1250-189 Lisboa, Portugal

Location

Related Publications (1)

• Ribeiro RT, Andrade R, Nascimento do O D, Lopes AF, Raposo JF. Impact of blinded retrospective continuous glucose monitoring on clinical decision making and glycemic control in persons with type 2 diabetes on insulin therapy. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1267-1275. doi: 10.1016/j.numecd.2020.12.024. Epub 2020 Dec 31.

  PMID: 33612381 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Joao Raposo, MD PhD

  Associacao Protectora dos Diabeticos de Portugal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of clinical outcomes and patient reported outcomes

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: March 22, 2015
• Primary Completion: January 24, 2017
• Study Completion: March 1, 2018
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)