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Completed

NCT Number: NCT05550480

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

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.

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Key information

Conditions

Pancreatogenic Type 3C Diabetes Mellitus Chronic Disease Diabetes Mellitus Digestive System Diseases Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Aalborg Hospital

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Continuous glucose monitoring

Device

Continuous glucose monitoring for 50 days

Other names: CGM

Primary outcomes

  1. Time spent with glucose value <3.0 mmol/l (level 2 hypoglycemia)

    Time frame: 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.

    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.

Secondary outcomes

  1. Time in range (glucose value 3.9 - 10.0 mmol/l)

    Time frame: 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.

    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.

  2. Time below range (glucose <3.9 mmol/L)

    Time frame: 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.

    The difference between CGM and self-monitoring of blood glucose in time below range (glucose value < 3.9 mmol/L) measured by CGM.

  3. Time below range (glucose 3.0-3.8 mmol/L, hypoglycaemia level 1)

    Time frame: 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.

    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.

  4. Time above range (glucose >10.0 mmol/L)

    Time frame: 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.

    The difference between CGM and self-monitoring of blood glucose in time above range (glucose value >10.0 mmol/L) measured by CGM.

  5. Time above range (glucose 10.1-13.9 mmol/L, hyperglycaemia level 1)

    Time frame: 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.

    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.

  6. Time above range (glucose >13.9 mmol/L, hyperglycaemia level 2)

    Time frame: 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.

    The difference between CGM and self-monitoring of blood glucose in time above range (glucose value >13.9 mmol/L) measured by CGM.

  7. Mean glucose (mmol/L)

    Time frame: The last 20 ±2 days of each study period

    The difference between CGM and self-monitoring of blood glucose in mean glucose (mmol/L) measured by CGM.

  8. Mean amplitude of glycemic excursions [MAGE]

    Time frame: 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.

    The difference between CGM and self-monitoring of blood glucose in mean amplitude of glycemic excursions [MAGE] measured by CGM.

  9. Continuous overall net glycemic action [CONGA]

    Time frame: 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.

    The difference between CGM and self-monitoring of blood glucose in continuous overall net glycemic action [CONGA] measured by CGM.

  10. Insulin dose (unit)

    Time frame: The last 20 ±2 days of each study period

    The difference in the mean insulin dose between CGM and self-monitoring of blood glucose.

  11. Quality of life (EORTC QLQ-C30)

    Time frame: At the end of each study period (day 70 ±2 and 140 ±2).

    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.

  12. Patient global impression of change score (PGIC)

    Time frame: At the end of each study period (day 70 ±2 and 140 ±2).

    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.

  13. Hypoglycemia awareness

    Time frame: At the end of each study period (day 70 ±2 and 140 ±2).

    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.

  14. Standard deviation (mmol/L)

    Time frame: 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.

    The difference between CGM and self-monitoring of blood glucose in standard deviation of mean glucose (mmol/L) measured by CGM.

  15. Coefficient of variance (%)

    Time frame: 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.

    The difference between CGM and self-monitoring of blood glucose in coefficient of variance of mean glucose (mmol/L) measured by CGM.

  16. HbA1c (mmol/L)

    Time frame: At the end of each study period (day 70 ±2 and 140 ±2).

    The difference between CGM and self-monitoring of blood glucose in HbA1c mmol/L.

  17. HbA1c (percentage)

    Time frame: At the end of each study period (day 70 ±2 and 140 ±2).

    The difference between CGM and self-monitoring of blood glucose in HbA1c (percentage).

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2022
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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