DIabetes GLycemic Assessment in Newly Confirmed Episodes (DI-GLANCE)
Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis
This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose [SMBG] using conventional glucometers).
The gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.
調査の概要
状態
詳細な説明
Newly diagnosed Type 2 Diabetes (T2D) represents a critical therapeutic window where intensive glycemic control can significantly preserve beta-cell function, reduce glycemic variability, and potentially induce diabetes remission. International guidelines emphasize that early, tight glycemic control is strongly associated with a better long-term prognosis and a reduced risk of micro- and macrovascular complications. However, traditional self-monitoring of blood glucose (SMBG) via finger-prick glucometers offers only static "snapshots" of glucose levels, missing critical fluctuations, asymptomatic hypoglycemia, and postprandial spikes. Routine indicators like fasting plasma glucose and glycated hemoglobin (HbA1c) fail to capture the full spectrum of glycemic variability, which is an independent risk factor for cardiovascular disease.
Recently, Continuous Glucose Monitoring (CGM) technology has emerged as a transformative tool, providing real-time, 24-hour glucose profiles. Beyond its clinical utility, CGM serves as a powerful biofeedback mechanism, motivating patients to adopt sustainable lifestyle changes-such as targeted physical activity, dietary adjustments, and improved sleep hygiene. While CGM is widely adopted in established diabetes management, its clinical utility, impact on patient adherence, and quality of life in individuals with newly diagnosed T2DM who are starting or optimizing non-insulin pharmacological therapies remain insufficiently explored.
This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose [SMBG] using conventional glucometers).
The intensive intervention period with the assigned monitoring devices (CGM or SMBG) and pedometers will last for the first 1 month, followed by a 2-month observation phase. The study consists of three outpatient visits:
- Visit 1 (Baseline);
- Visit 2 (1 month, end of active intervention);
- Visit 3 (3 months, end of follow-up period).
During these visits, comprehensive metabolic, anthropometric, and psychological assessments will be conducted, including HbA1c, fructosamine, C-peptide, insulin resistance indices (HOMA2-IR), lipid profile, body mass index (BMI), waist circumference, bioimpedance body composition analysis, objective physical activity monitoring (pedometer data), and the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire to evaluate health-related quality of life.
The gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Kyiv、ウクライナ、01601
- 募集
- Bogomolets National Medical University
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コンタクト：
- Nazarii Kobyliak, Professor
- 電話番号：0442356005
- メール：nazariikobyliak@gmail.com
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コンタクト：
- Ilona Rudneva, PhD student
- 電話番号：0442356005
- メール：ilonarudneva57@gmail.com
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主任研究者：
- Nazarii Kobyliak, Professor
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副調査官：
- Eva Ilkiv, PhD Student
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Kyiv、ウクライナ、01601
- 募集
- University Hospital of Bogomolets National Medical University
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コンタクト：
- Ilona Rudneva, PhD student
- 電話番号：0442356005
- メール：ilonarudneva57@gmail.com
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コンタクト：
- Victoriia Yerokhovych, PhD
- 電話番号：0442356005
- メール：korinnaviktoriaer@gmail.com
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Kyiv、ウクライナ、01601
- 招待による登録
- Bogomoletz Institute of Physiology
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age of 18 years and older.
- Newly diagnosed Type 2 Diabetes Mellitus according to ADA (American Diabetes Association) criteria (Fasting Plasma Glucose ≥ 7.0 mmol/L, or 2-hour Post-Prandial Glucose ≥ 11.1 mmol/L during OGTT, or HbA1c ≥6.5%).
- Time since the initial diagnosis of T2D must not exceed 3 months ( less 90 days) at the time of screening.
- HbA1c level between 6.5% and 9.5% (inclusive) at screening.
- Patients may be lifestyle-controlled or receiving any stable non-insulin anti-diabetic therapy (including Metformin, SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or Sulfonylureas) as monotherapy or combination therapy.
- Ability to provide written informed consent and willingness to adhere to the study protocol and follow-up schedule.
Exclusion Criteria:
- Diagnosis or suspicion of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA) (e.g., positive anti-GAD antibodies if tested), or secondary types of diabetes (e.g., pancreatic or drug-induced).
- Any prior or current use of insulin therapy.
- Severe microvascular or macrovascular complications (proliferative retinopathy, severe diabetic nephropathy with eGFR < 45 mL/min/1.73m², diabetic foot ulcers, severe peripheral neuropathy).
- Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia.
- History of myocardial infarction, stroke, unstable angina, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) within the past 6 months.
- Active malignancy, decompensated heart failure (NYHA Class III or IV), or chronic infectious diseases.
- Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception.
- Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant.
- Participation in another clinical study within the last 3 months.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：traditional fingerstick glucometer
Participants with prediabetes will be provided with traditional fingerstick glucometer device to self-monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services.
Pre and post intervention surveys and investigation will be implemented.
Participants will be utilizing glucometer with at least 2-3 measurements per week for 28 days and then followed up for 3-month participation.
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Capillary glucose monitoring using fingerstick glucometer as per standard care.
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実験的：CGM group
articipants with prediabetes will be provided with a Real-Time Continuous Glucose Monitoring (RT-CGM) device to monitor their blood glucose along with educational materials to better understand and manage their prediabetes and other supporting services.
Pre and post intervention surveys and investigation will be implemented.
Participants will be utilizing RT-CGM device for 28 days and then followed up for 3-month participation.
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A registered medical device for real-time monitoring of glucose levels in interstitial fluid.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in HbA1c level
時間枠：at 3 month (end of follow-up period)
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HbA1c in %
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at 3 month (end of follow-up period)
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Changes in Fructosamine level
時間枠：at 1 month (end of intervention period)
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Fructosamine in μmol/L
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at 1 month (end of intervention period)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
body mass index (BMI)
時間枠：at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
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weight in kg and height in meters will be combined to report BMI in kg/m^2
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at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
|
|
waist circumferences (WC)
時間枠：at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
|
WC in cm
|
at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
|
|
Total Cholesterol (TC)
時間枠：at 3 month (follow-up period) compared to baseline
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TC in mmol/l
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at 3 month (follow-up period) compared to baseline
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Tryglicerides (TG)
時間枠：at 3 month (follow-up period) compared to baseline
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TG in mmol/l
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at 3 month (follow-up period) compared to baseline
|
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LDL-Cholesterol (LDL-C)
時間枠：at 3 month (follow-up period) compared to baseline]
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LDL-C in mmol/l
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at 3 month (follow-up period) compared to baseline]
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Physical activity levels
時間枠：at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
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Daily number of steps as measured by a sealed pedometer
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at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
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Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR)
時間枠：at 3 month (follow-up period) compared to baseline
|
HOMA2-IR will be calculated based on fasting plasma glucose and fasting serum insulin levels using the non-linear Homeostasis Model Assessment.
The score is continuous, theoretically starting from 0, where higher values indicate greater insulin resistance (a worse clinical outcome).
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at 3 month (follow-up period) compared to baseline
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insulin sensitivity (%S)
時間枠：at 3 month (follow-up period) compared to baseline
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This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
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at 3 month (follow-up period) compared to baseline
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β-cell function (%B)
時間枠：at 3 month (follow-up period) compared to baseline
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This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
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at 3 month (follow-up period) compared to baseline
|
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Quality of Life Evaluation: Medical Outcomes Study Short-Form 36 (SF-36)
時間枠：at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
|
Health-related quality of life will be evaluated using the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire.
The SF-36 consists of 36 items measuring 8 health domains, which are aggregated into two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
For each domain and summary score, values are transformed to a scale ranging from a minimum of 0 to a maximum of 100.
Higher scores represent better health status and a better quality of life outcome.
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at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
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visceral fat content
時間枠：at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
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visceral fat content using electronic scales-analyzers of body composition Huawei (Smart Scale series 3/3 Pro)
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at 1 month (end of intervention) and 3 month (follow-up period) compared to baseline
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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