ベータ
治験レーダーAI
フィルター基準に一致する試験が1件見つかりました
タイル表示
検索に戻る

Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes 30

完了
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05550480 は 介入研究 臨床試験 で、Pancreatogenic Type 3C Diabetes Mellitus を対象とした研究でした。現在は 完了 です。2022年9月8日 に開始し、30 名の参加者 が参加しました。この試験は オールボー大学 によって主導され、2024年6月5日 に完了しました。ClinicalTrials.gov からの最新更新日は 2024年10月4日 です。
概要
This study will investigate the effect of continuous glucose monitoring (CGM) (compared to self-monitoring) on hypoglycemia and glycemic control in patients with insulin-treated pancreatogenic diabetes.
詳細説明
The use of CGM in people with type 1 or type 2 diabetes receiving multiple daily insulin injections improves glycemic control and reduces time spent in hypoglycemia compared to self-monitoring. These beneficial effects of CGM are likely also present in people with pancreatogenic diabetes but have only been sparsely investigated.

In this study, the investigators, therefore, aim to investigate the effects of CGM (comp...

もっと見る
公式タイトル

Effect of Continuous Glucose Monitoring on Hypoglycemia in Adults With Pancreatogenic Diabetes

疾患名
Pancreatogenic Type 3C Diabetes Mellitus
その他の研究識別子
  • N-20210064
  • N-20210064 (その他の識別子) (North Denmark Region Committee in Health Research Ethics)
NCT番号
NCT05550480
開始日
2022-09-08
最終更新日
2024-10-04
終了予定日
2024-06-05
目標参加者数
30
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
Chronic pancreatitis
Pancreatic Diseases
Digestive System Diseases
Diabetes
Continuous Glucose Monitoring
主目的
治療
割付方法
無作為化
介入モデル
クロスオーバー法
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的Continuous glucose monitoring
Participants will monitor their glucose levels using CGM with access to interstitial glucose levels continuously throughout the day. Each study period is preceded by 20 days of masked CGM assessment.
持続血糖モニタリング
Continuous glucose monitoring for 50 days
非介入Self-monitoring of blood glucose
Participants will monitor their blood glucose levels using a glucometer and a capillary blood sample from finger-pricking. Participants will in addition use masked CGM for the last 20 days of the study period to monitor glucose levels for comparison. Each study period is preceded by 20 days of masked CGM assessment.
該当なし
主要評価項目
評価指標指標の説明時間枠
Time spent with glucose value <3.0 mmol/l (level 2 hypoglycemia)
The difference between CGM and self-monitoring of blood glucose in time spent with glucose value \<3.0 mmol/l (level 2 hypoglycemia) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
副次評価項目
評価指標指標の説明時間枠
Time in range (glucose value 3.9 - 10.0 mmol/l)
The difference between CGM and self-monitoring of blood glucose in time in range (glucose value 3.9 - 10.0 mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Time below range (glucose <3.9 mmol/L)
The difference between CGM and self-monitoring of blood glucose in time below range (glucose value \< 3.9 mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Time below range (glucose 3.0-3.8 mmol/L, hypoglycaemia level 1)
The difference between CGM and self-monitoring of blood glucose in time below range (glucose value 3.0-3.8 mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Time above range (glucose >10.0 mmol/L)
The difference between CGM and self-monitoring of blood glucose in time above range (glucose value \>10.0 mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Time above range (glucose 10.1-13.9 mmol/L, hyperglycaemia level 1)
The difference between CGM and self-monitoring of blood glucose in time above range (glucose value 10.1-13.9 mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Time above range (glucose >13.9 mmol/L, hyperglycaemia level 2)
The difference between CGM and self-monitoring of blood glucose in time above range (glucose value \>13.9 mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Mean glucose (mmol/L)
The difference between CGM and self-monitoring of blood glucose in mean glucose (mmol/L) measured by CGM.
The last 20 ±2 days of each study period
Mean amplitude of glycemic excursions [MAGE]
The difference between CGM and self-monitoring of blood glucose in mean amplitude of glycemic excursions \[MAGE\] measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Continuous overall net glycemic action [CONGA]
The difference between CGM and self-monitoring of blood glucose in continuous overall net glycemic action \[CONGA\] measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Insulin dose (unit)
The difference in the mean insulin dose between CGM and self-monitoring of blood glucose.
The last 20 ±2 days of each study period
Quality of life (EORTC QLQ-C30)
Difference between CGM and self-monitoring of blood glucose in quality of life assessed by EORTC QLQ-C30 questionnaire. The questionnaire has been validated for assessment of quality of life in patients with chronic pancreatitis and is composed of single-item measures and multi-item scales with scores ranging from 0 to 100 after linear transformation of the raw score. A high score for a functional scale represents a high level of functioning, as does a high score for the global health status, while a high score for the symptom items represents a high level of symptomatology.
At the end of each study period (day 70 ±2 and 140 ±2).
Patient global impression of change score (PGIC)
Difference between CGM and self-monitoring of blood glucose in Patient global impression of change score (PGIC). The PGIC is a self-reported measure used to assess a patient's overall perception of improvement or change in their condition over time. It uses a 7-point scale, ranging from "very much improved" to "very much worse". A score ≤3 means that the condition has improved.
At the end of each study period (day 70 ±2 and 140 ±2).
Hypoglycemia awareness
The difference between CGM and self-monitoring of blood glucose in hypoglycemia awareness assessed by the Clarke Hypoglycemia Awareness Survey. It comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to, hypoglycemia. A score of four or more implies impaired awareness of hypoglycemia.
At the end of each study period (day 70 ±2 and 140 ±2).
Standard deviation (mmol/L)
The difference between CGM and self-monitoring of blood glucose in standard deviation of mean glucose (mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
Coefficient of variance (%)
The difference between CGM and self-monitoring of blood glucose in coefficient of variance of mean glucose (mmol/L) measured by CGM.
In period 1, the observation period begins on day 50 ±2 days of the study and ends on day 70 ±2 days. In period 2, the observation period starts on day 120 ±2 days and ends on day 140 ±2 days.
HbA1c (mmol/L)
The difference between CGM and self-monitoring of blood glucose in HbA1c mmol/L.
At the end of each study period (day 70 ±2 and 140 ±2).
HbA1c (percentage)
The difference between CGM and self-monitoring of blood glucose in HbA1c (percentage).
At the end of each study period (day 70 ±2 and 140 ±2).
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  • Signed informed consent before any study specific procedures
  • Able to read and understand Danish
  • Male or female age ≥ 18 ≤ 85 years
  • A definitive diagnosis of chronic pancreatitis based on the M-ANNHEIM criteria
  • A diagnosis of insulin treated pancreatogenic diabetes based on the World Health Organization criteria for diabetes (HbA1c ≥6.5 % (48 mmol/mol) and/or fasting plasma glucose ≥126 mg/dl (7.0 mmol/l)) >3 months after diagnosis of pancreatitis

  • Known or suspected abdominal cancer (incl. intestine, pancreas, and the hepato-biliary system)
  • Severe pre-existing comorbidities (assessed by investigator upon inclusion)
  • Attack of acute on chronic pancreatitis requiring admission within four weeks prior to inclusion
  • Use of glucocorticoid medications within four weeks prior to inclusion, with the exception of inhaled glucocorticoids in the treatment of chronic pulmonary diseases.
  • Presence of autoimmune antibodies suggestive of type 1 diabetes
  • Prior pancreatic surgery (including total pancreatectomy, pancreaticoduodenectomy, distal pancreatectomy, pancreaticojejunostomy, enucleation, or Frey procedure)
  • Prior gastric surgery or vagotomy
  • Autoimmune pancreatitis
Aalborg University Hospital logoオールボー大学198 件のアクティブな治験を探索
責任者
Soren Schou Olesen, 主任研究者, Professor, Chief Physician, MD, PhD, Aalborg University Hospital
連絡先情報がありません。
1 1カ国の場所
Department of Gastroenterology, Aalborg Hospital, Aalborg, 9000, Denmark