AzTrials
AzTrials

HypoglycemiaSMARTNCT05133765

The SMART B Exercise Study :''The SMART Study''

A study testing Insulin pump in people with Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Despite the established health benefits conveyed by physical activity for people with type 1 diabetes (T1D), participation rates remain low, with fear of hypoglycaemia, lack of freedom to engage in unplanned activities, and uncertainty in making appropriate adjustments to insulin and nutritional therapy reported as… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypoglycemia
What is being tested?
Insulin pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteDenmark
Study dates
14 Sep 2021to 7 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Type 1 diabetes ≥2 years.
  • HbA1c;
  • 58-63 mmol/mol (maximum 30% of participants) OR
  • ≥ 64 mmol/mol (minimum 70% of participants)
  • Insulin pump treatment ≥12 months
  • CGM or isCGM use ≥6 months
Show all 9Show fewer
  • Novorapid use ≥4 weeks
  • Carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals.
  • Carbohydrate intake >80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit)

Who cannot join

  • • Breast-feeding, pregnancy or planning to become pregnant.
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
  • Use of hybrid closed-loop systems
  • Daily use of paracetamol (acetaminophen)
  • Alcohol or drug abuse.
  • Severe cardiac disease or retinopathy contraindicating HbA1c <53 mmol/mol.
Show all 9Show fewer
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the person unsuitable for study participation.
  • Lack of compliance with key study procedures at the discretion of the investigator.
  • Unacceptable adverse events at the discretion of the investigator

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

Official title: Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study''

Despite the established health benefits conveyed by physical activity for people with type 1 diabetes (T1D), participation rates remain low, with fear of hypoglycaemia, lack of freedom to engage in unplanned activities, and uncertainty in making appropriate adjustments to insulin and nutritional therapy reported as the leading barriers to regular exercise engagement. Indeed, the synergistic glucose lowering effects of peripheral hyperinsulinaemia and exercising muscle tissue accentuate the risk of exercise-related hypoglycaemia for individuals with T1D, particularly if performed post-prandially. Hence, the introduction of commercially available artificial pancreas systems, also known as ''advanced hybrid-closed-loop'' (AHCL) systems, that regulate insulin rates with minimal user interaction constitute compelling therapeutic aids with clinically relevant potential. Nevertheless, we know little about their safe and efficacious integration around dynamic physical exercise. Nor do we know how alterations in carbohydrate fueling strategies around exercise effect subsequent glucose trends.

This study aims to 1) compare the efficacy of an AHCL system versus usual care insulin pump therapy, with carbohydrates taken before or during exercise, in optimising TIR around dynamic physical exercise and 2) explore the influence of carbohydrate intake before versus during exercise on the metabolomic, hormonal and physiological responses to exercise.

Read the detailed description

Following successful completion of a screening visit, participants will attend the laboratory to complete 3 experimental visits during which they will undertake a 45-minute bout of moderate intensity continuous exercise on a bicycle ergometer at ~60% of the individualised VȮ2max. Prior to commencing exercise, participants will consume a standardised low-glycaemic index, carbohydrate-based meal (equating to 0.75g.CHO.kg.bm-1) with, or without, a 25% reduction in their meal-time insulin dose as well as with carbohydrates before or during exercise (according to the randomisation). Venous blood glucose sampling will be taken in 15-minute intervals leading into and after exercise with 5-minute intervals performed during exercise. Samples will be used to retrospectively cross-compare the metabolic, hormonal, and physiological responses between visits. Visits 1 \& 2 will be separated by ≥14 days to ensure adequate familiarisation with the AHCL system whilst visits 2 \& 3 will be separated by ≥3days. Each participant will undertake 1 screening and 3 experimental visits equating to a total of 80 study visits.

Conditions
Hypoglycemia
Being tested
Insulin pump
Medical subject headings
Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin pumpDevice

    Alterations in insulin pump therapy or carbohydrate consumption

Study groups in NCT05133765
Study groupRoleWhat they receive
SMART B1 - Usual care insulin pumpExperimentalUsual care pump therapy arm with carbohydrate consumption before exercise
Receives: Device: Insulin pump
SMART B2 - Advanced hybrid closed loop insulin pump with carbohydrates before exerciseExperimentalAdvanced hybrid closed loop therapy arm with carbohydrate consumption before exercise
Receives: Device: Insulin pump
SMART B3 - Advanced hybrid closed loop insulin pump with carbohydrates during exerciseExperimentalAdvanced hybrid closed loop therapy arm with carbohydrate consumption during exercise
Receives: Device: Insulin pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise

    Comparison of the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise

    Measured: 0 minutes to +105 minutes

Secondary outcomes (1)

  1. To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise

    To compare the influence of carbohydrate feeding before versus during exercise on the physiological responses to dynamic physical exercise

    Measured: 0 minutes to +45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start14 Sep 2021
  3. Primary completion7 Oct 2022
  4. Study completion7 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Three period randomised cross-over clinical trial
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05133765
Sponsor's protocol ID
SMART B
Acronym
SMART
Status last verified
Nov 2022
First submitted
14 Sep 2021
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • McCarthy OM, Christensen MB, Kristensen KB, Schmidt S, Ranjan AG, Bain SC, Bracken RM, Norgaard K. Glycemia Around Exercise in Adults with Type 1 Diabetes Using Automated and Nonautomated Insulin Delivery Pumps: A Switch Pilot Trial. Diabetes Technol Ther. 2023 Apr;25(4):287-292. doi: 10.1089/dia.2022.0542. Epub 2023 Feb 16.

    PubMed 36724311

  • McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, Ranjan AG, Nicholas C, Bain SC, Norgaard K, Bracken R. Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy. Diabetes Obes Metab. 2023 Mar;25(3):878-888. doi: 10.1111/dom.14938. Epub 2023 Jan 3.

    PubMed 36482870

Questions about this trial

What is this clinical trial studying?

A study testing Insulin pump in people with Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise (time frame: 0 minutes to +105 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05133765, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in