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| ID | Type | Description | Link |
|---|---|---|---|
| N-20210064 | Other Identifier | North Denmark Region Committee in Health Research Ethics |
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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.
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 (compared to self-monitoring) on hypoglycemia and glycemic control in patients with pancreatogenic diabetes. Patients with chronic pancreatitis and insulin-treated diabetes will be randomized 1:1 to receive 50 days of CGM followed by 50 days of self-monitoring or vice versa. Each study period is preceded by 20 days of masked CGM assessment, which also serves as the washout period between the two study periods. Furthermore, the self-monitoring group will use masked CGM for the last 20 days of the study period to monitor glucose levels for comparison with the unmasked CGM period. Thus, each study period lasts a total of 70 days.
The investigators hypothesize that the use of CGM vs self-monitoring of blood glucose in patients with pancreatogenic diabetes will lead to decreased time spent with a glucose value <3.0 mmol/l and increased time in glycemic range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous glucose monitoring | Experimental | 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. |
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| Self-monitoring of blood glucose | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | Continuous glucose monitoring for 50 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren S Olesen, Professor | Mech-Sense, Department of Gastroenterology, Aalborg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Aalborg Hospital | Aalborg | 9000 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2022 | Sep 15, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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). |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |